{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-06-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Hydrating Sheer Lip Balm SPF 30 -Crystal Broad Spectrum SPF 30 UVA-UVB Sunscreen Avobenzone, Octisalate, and Homosalate AVOCADO OIL SHEA BUTTER HYDROGENATED SOYBEAN OIL PARAFFIN OCTYLDODECANOL CASTOR OIL OLIVE OIL BUTYLOCTYL SALICYLATE CORN OIL HYDROGENATED JOJOBA OIL, RANDOMIZED STEARIC ACID MICROCRYSTALLINE WAX HELIANTHUS ANNUUS SEED WAX SQUALANE TETRAHEXYLDECYL ASCORBATE .ALPHA.-TOCOPHEROL ACETATE TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX ACACIA DECURRENS FLOWER WAX POLYGLYCERIN-3 AVOBENZONE AVOBENZONE OCTISALATE OCTISALATE HOMOSALATE HOMOSALATE Hydrating Sheer Lip Balm SPF 30 - BARE Broad Spectrum SPF 30 UVA-UVB Sunscreen Avobenzone, Octisalate, and Homosalate AVOCADO OIL SHEA BUTTER HYDROGENATED SOYBEAN OIL PARAFFIN CASTOR OIL OLIVE OIL BUTYLOCTYL SALICYLATE CORN OIL HYDROGENATED JOJOBA OIL, RANDOMIZED MICROCRYSTALLINE WAX STEARIC ACID HELIANTHUS ANNUUS SEED WAX SQUALANE POLYGLYCERIN-3 TETRAHEXYLDECYL ASCORBATE .ALPHA.-TOCOPHEROL ACETATE TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX ACACIA DECURRENS FLOWER WAX SORBITAN MONOOLEATE AVOBENZONE AVOBENZONE OCTISALATE OCTISALATE HOMOSALATE HOMOSALATE Hydrating Sheer Lip Balm SPF 30 - BLUSH Broad Spectrum SPF 30 UVA-UVB Sunscreen Avobenzone, Octisalate, and Homosalate AVOCADO OIL SHEA BUTTER HYDROGENATED SOYBEAN OIL PARAFFIN CASTOR OIL OLIVE OIL BUTYLOCTYL SALICYLATE CORN OIL HYDROGENATED JOJOBA OIL, RANDOMIZED MICROCRYSTALLINE WAX STEARIC ACID HELIANTHUS ANNUUS SEED WAX SQUALANE POLYGLYCERIN-3 TETRAHEXYLDECYL ASCORBATE .ALPHA.-TOCOPHEROL ACETATE TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX ACACIA DECURRENS FLOWER WAX SORBITAN MONOOLEATE AVOBENZONE AVOBENZONE OCTISALATE OCTISALATE HOMOSALATE HOMOSALATE Hydrating Sheer Lip Balm SPF 30 - RUBY Broad Spectrum SPF 30 UVA-UVB Sunscreen Avobenzone, Octisalate, and Homosalate AVOCADO OIL SHEA BUTTER HYDROGENATED SOYBEAN OIL PARAFFIN CASTOR OIL OLIVE OIL BUTYLOCTYL SALICYLATE CORN OIL HYDROGENATED JOJOBA OIL, RANDOMIZED MICROCRYSTALLINE WAX STEARIC ACID HELIANTHUS ANNUUS SEED WAX SQUALANE POLYGLYCERIN-3 TETRAHEXYLDECYL ASCORBATE .ALPHA.-TOCOPHEROL ACETATE TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX ACACIA DECURRENS FLOWER WAX SORBITAN MONOOLEATE AVOBENZONE AVOBENZONE OCTISALATE OCTISALATE HOMOSALATE HOMOSALATE Hydrating Sheer Lip Balm SPF 30 - SHIMMER Broad Spectrum SPF 30 UVA-UVB Sunscreen Avobenzone, Octisalate, and Homosalate AVOCADO OIL SHEA BUTTER HYDROGENATED SOYBEAN OIL PARAFFIN CASTOR OIL OLIVE OIL BUTYLOCTYL SALICYLATE CORN OIL HYDROGENATED JOJOBA OIL, RANDOMIZED MICROCRYSTALLINE WAX STEARIC ACID HELIANTHUS ANNUUS SEED WAX SQUALANE POLYGLYCERIN-3 TETRAHEXYLDECYL ASCORBATE .ALPHA.-TOCOPHEROL ACETATE TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX ACACIA DECURRENS FLOWER WAX SORBITAN MONOOLEATE AVOBENZONE AVOBENZONE OCTISALATE OCTISALATE HOMOSALATE HOMOSALATE Hydrating Sheer Lip Balm SPF 30 - SPICE Broad Spectrum SPF 30 UVA-UVB Sunscreen Avobenzone, Octisalate, and Homosalate AVOCADO OIL SHEA BUTTER HYDROGENATED SOYBEAN OIL PARAFFIN CASTOR OIL OLIVE OIL BUTYLOCTYL SALICYLATE CORN OIL HYDROGENATED JOJOBA OIL, RANDOMIZED MICROCRYSTALLINE WAX STEARIC ACID HELIANTHUS ANNUUS SEED WAX SQUALANE POLYGLYCERIN-3 TETRAHEXYLDECYL ASCORBATE .ALPHA.-TOCOPHEROL ACETATE TOCOPHEROL ASCORBYL PALMITATE TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX ACACIA DECURRENS FLOWER WAX SORBITAN MONOOLEATE MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE AVOBENZONE AVOBENZONE OCTISALATE OCTISALATE HOMOSALATE HOMOSALATE Hydrating Sheer Lip Balm SPF 30 - DREAM Broad Spectrum SPF 30 UVA-UVB Sunscreen Avobenzone, Octisalate, and Homosalate AVOCADO OIL SHEA BUTTER HYDROGENATED SOYBEAN OIL PARAFFIN CASTOR OIL OLIVE OIL BUTYLOCTYL SALICYLATE CORN OIL HYDROGENATED JOJOBA OIL, RANDOMIZED MICROCRYSTALLINE WAX STEARIC ACID HELIANTHUS ANNUUS SEED WAX SQUALANE POLYGLYCERIN-3 TETRAHEXYLDECYL ASCORBATE .ALPHA.-TOCOPHEROL ACETATE TOCOPHEROL ASCORBYL PALMITATE TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX ACACIA DECURRENS FLOWER WAX SORBITAN MONOOLEATE MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE AVOBENZONE AVOBENZONE OCTISALATE OCTISALATE HOMOSALATE HOMOSALATE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "DISTRIBUTED BY MDSOLARSCIENCES CORP. GREENS FARMS, CT 06838"
      ],
      "active_ingredient": [
        "Active ingredients Purpose Avobenzone 3% Sunscreen Octisalate 5% Sunscreen Homosalate 10% Sunscreen"
      ],
      "active_ingredient_table": [
        "<table width=\"50%\"><col width=\"70%\" align=\"left\" valign=\"middle\"/><col width=\"30%\" align=\"right\" valign=\"middle\"/><thead><tr><th>Active ingredients</th><th>Purpose</th></tr></thead><tbody><tr><td>Avobenzone 3%</td><td>Sunscreen</td></tr><tr><td>Octisalate 5%</td><td>Sunscreen</td></tr><tr><td>Homosalate 10%</td><td>Sunscreen</td></tr></tbody></table>"
      ],
      "purpose": [
        "Active ingredients Purpose Avobenzone 3% Sunscreen Octisalate 5% Sunscreen Homosalate 10% Sunscreen"
      ],
      "purpose_table": [
        "<table width=\"50%\"><col width=\"70%\" align=\"left\" valign=\"middle\"/><col width=\"30%\" align=\"right\" valign=\"middle\"/><thead><tr><th>Active ingredients</th><th>Purpose</th></tr></thead><tbody><tr><td>Avobenzone 3%</td><td>Sunscreen</td></tr><tr><td>Octisalate 5%</td><td>Sunscreen</td></tr><tr><td>Homosalate 10%</td><td>Sunscreen</td></tr></tbody></table>"
      ],
      "indications_and_usage": [
        "Uses Helps prevent sunburn If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun."
      ],
      "warnings": [
        "Warnings For external use only Do not use on damaged or broken skin Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "do_not_use": [
        "Do not use on damaged or broken skin"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions Apply liberally 15 minutes before sun exposure Reapply: use a water resistant sunscreen if swimming or sweating at least every 2 hours Children under 6 months: Ask a doctor Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10a.m.- 2p.m. Wear long-sleeved shirts, pants, hats and sunglasses"
      ],
      "storage_and_handling": [
        "Other Information Protect the product in this container from excessive heat and direct sunlight You may report serious adverse reactions to: Report Reaction, LLC., PO Box 22, Plainsboro, NJ 08536-0222"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Persea Gratissima (Avocado) Oil, Butyrospermum Parkii (Shea) Butter, Hydrogenated Soybean Oil, Paraffin, Ricinus Communis (Castor) Seed Oil, Olea Europaea (Olive) Fruit Oil, Octyldodecanol, Butyloctyl Salicylate, Hydrogenated Vegetable Oil, Jojoba Esters, Microcrystalline Wax, Stearic Acid, Helianthus Annuus (Sunflower) Seed Wax, Squalene, Polyglycerin-3, Tetrahexyldecyl Ascorbate (Vitamin C), Tocopheryl Acetate (Vitamin E), Ascorbyl Palmitate (Vitamin C), Tocopherol (Vitamin E), Rhus Verniciflua Peel Wax, Acacia Decurrens Flower Wax, Sorbitan Oleate, Synthetic Fluorphlogopite, May contain: CI 77891, CI 77491, CI 77492, CI 77499, CI 15850, CI 42090, CI 77861, CI 45410, CI 19140"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Crystal MDSOLARSCIENCES ® HYDRATING SHEER LIP BALM Broad Spectrum SPF 30 SPF 30 CRYSTAL DERMATOLOGIST DEVELOPED SHEA BUTTER VITAMIN E AVOCADO OIL VITAMIN C .15 OZ / 4.2 G PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Crystal",
        "PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Bare MDSOLARSCIENCES ® PROTECT & NOURISH HYDRATING SHEER LIP BALM Broad Spectrum SPF 30 SPF 30 BARE SHEA BUTTER VITAMIN E AVOCADO OIL VITAMIN C .15 OZ / 4.2 G PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Bare",
        "PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Blush MDSOLARSCIENCES ® PROTECT & NOURISH HYDRATING SHEER LIP BALM Broad Spectrum SPF 30 SPF 30 BLUSH SHEA BUTTER VITAMIN E AVOCADO OIL VITAMIN C .15 OZ / 4.2 G PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Blush",
        "PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Ruby MDSOLARSCIENCES ® PROTECT & NOURISH HYDRATING SHEER LIP BALM Broad Spectrum SPF 30 SPF 30 RUBY SHEA BUTTER VITAMIN E AVOCADO OIL VITAMIN C .15 OZ / 4.2 G PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Ruby",
        "PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Shimmer MDSOLARSCIENCES ® PROTECT & NOURISH HYDRATING SHEER LIP BALM Broad Spectrum SPF 30 SPF 30 SHIMMER SHEA BUTTER VITAMIN E AVOCADO OIL VITAMIN C .15 OZ / 4.2 G PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Shimmer",
        "PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Spice MDSOLARSCIENCES ® PROTECT & NOURISH HYDRATING SHEER LIP BALM Broad Spectrum SPF 30 SPF 30 SPICE SHEA BUTTER VITAMIN E AVOCADO OIL VITAMIN C .15 OZ / 4.2 G PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Spice",
        "PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Dream MDSOLARSCIENCES ® PROTECT & NOURISH HYDRATING SHEER LIP BALM Broad Spectrum SPF 30 SPF 30 DREAM SHEA BUTTER VITAMIN E AVOCADO OIL VITAMIN C .15 OZ / 4.2 G PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Dream"
      ],
      "set_id": "0f23441c-2399-4a72-9f0a-420d25db78af",
      "id": "36d8ea31-6d00-0d8f-e063-6394a90ae824",
      "effective_time": "20250605",
      "version": "2",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Hydrating Sheer Lip Balm SPF 30 -Crystal Broad Spectrum SPF 30 UVA-UVB Sunscreen",
          "Hydrating Sheer Lip Balm SPF 30 - BARE Broad Spectrum SPF 30 UVA-UVB Sunscreen",
          "Hydrating Sheer Lip Balm SPF 30 - BLUSH Broad Spectrum SPF 30 UVA-UVB Sunscreen",
          "Hydrating Sheer Lip Balm SPF 30 - RUBY Broad Spectrum SPF 30 UVA-UVB Sunscreen",
          "Hydrating Sheer Lip Balm SPF 30 - SHIMMER Broad Spectrum SPF 30 UVA-UVB Sunscreen",
          "Hydrating Sheer Lip Balm SPF 30 - SPICE Broad Spectrum SPF 30 UVA-UVB Sunscreen",
          "Hydrating Sheer Lip Balm SPF 30 - DREAM Broad Spectrum SPF 30 UVA-UVB Sunscreen"
        ],
        "generic_name": [
          "AVOBENZONE, OCTISALATE, AND HOMOSALATE"
        ],
        "manufacturer_name": [
          "MDSolarSciences"
        ],
        "product_ndc": [
          "49358-600",
          "49358-601",
          "49358-602",
          "49358-603",
          "49358-604",
          "49358-605",
          "49358-606"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "AVOBENZONE",
          "HOMOSALATE",
          "OCTISALATE"
        ],
        "spl_id": [
          "36d8ea31-6d00-0d8f-e063-6394a90ae824"
        ],
        "spl_set_id": [
          "0f23441c-2399-4a72-9f0a-420d25db78af"
        ],
        "package_ndc": [
          "49358-600-01",
          "49358-601-01",
          "49358-602-01",
          "49358-603-01",
          "49358-604-01",
          "49358-605-01",
          "49358-606-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0349358001643",
          "0349358001391"
        ],
        "unii": [
          "4X49Y0596W",
          "V06SV4M95S",
          "G63QQF2NOX"
        ]
      }
    }
  ]
}