{
  "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": "2026-10-28",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Lip Shine SPF35 Sunscreen Zinc Oxide Zinc Oxide Zinc Oxide Phenyl Trimethicone Neopentyl Glycol Diheptanoate Disteardimonium Hectorite MICA Ethylhexyl Palmitate Triethyl Citrate Glyceryl Isostearate .ALPHA.-TOCOPHEROL ACETATE CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3) POLYHYDROXYSTEARIC ACID (2300 MW) Tribehenin HYALURONATE SODIUM Palmitoyl Tripeptide-1 Sorbitan Isostearate LIMONENE, (+)- STANNIC OXIDE FERRIC OXIDE RED FERROSOFERRIC OXIDE FERRIC OXIDE YELLOW CARMINIC ACID TITANIUM DIOXIDE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Distributed in USA by Colorescience ® Carlsbad, CA 92011"
      ],
      "active_ingredient": [
        "Active ingredients Zinc Oxide 6.6%"
      ],
      "purpose": [
        "Purpose Sunscreen"
      ],
      "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. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. 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."
      ],
      "when_using": [
        "When using this product keep out of eyes. Rinse with water to remove."
      ],
      "stop_use": [
        "Stop use and ask a doctor if rash occurs."
      ],
      "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. Works best on moisturized skin. Reapply: After 40 minutes of swimming or sweating. Immediately after towel drying. 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 this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m.– 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Phenyl Trimethicone, Bis-Vinyl Dimethicone/ Dimethicone Copolymer, Neopentyl Glycol Diheptanoate, Disteardimonium Hectorite, Mica, Ethylhexyl Palmitate, Tocopheryl Acetate, Triethyl Citrate, Glyceryl Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Polyhydroxystearic Acid, Tribehenin, Sodium Hyaluronate, Palmitoyl Tripeptide-1, Sorbitan Isostearate, Tin Oxide, Flavor/Aroma, Limonene, Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891), Carmine (CI 75470). Contains Carmine as a color additive."
      ],
      "storage_and_handling": [
        "Other information Protect this product from excessive heat and direct sun."
      ],
      "questions": [
        "Questions or comments? Call toll free 866.426.5673"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 4 mL Tube Carton colorescience ® LIP SHINE Moisturizes & smooths lips Defends against UV rays Tint of color, natural shine Water resistant (40 minutes) 35 Broad Spectrum SPF 35 Sunscreen 0.13 fl. oz. / 4 mL PRINCIPAL DISPLAY PANEL - 4 mL Tube Carton"
      ],
      "set_id": "3a6506c4-1ba9-493a-a4c8-e5f9c60d221b",
      "id": "10c37e69-e203-43fb-a8c3-50be826a74f1",
      "effective_time": "20241213",
      "version": "3",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Lip Shine SPF35 Sunscreen"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Colorescience"
        ],
        "product_ndc": [
          "68078-028"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "spl_id": [
          "10c37e69-e203-43fb-a8c3-50be826a74f1"
        ],
        "spl_set_id": [
          "3a6506c4-1ba9-493a-a4c8-e5f9c60d221b"
        ],
        "package_ndc": [
          "68078-028-01",
          "68078-028-02"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}