{
  "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": "2026-10-02",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk spf50 OCTINOXATE OCTINOXATE AVOBENZONE AVOBENZONE OCTOCRYLENE OCTOCRYLENE LANOLIN TITANIUM DIOXIDE BUTYROSPERMUM PARKII (SHEA) BUTTER WHITE WAX CAPRYLIC/CAPRIC TRIGLYCERIDE CI 77491 MYROTHAMNUS FLABELLIFOLIA TOP THEOBROMA CACAO (COCOA) SEED BUTTER HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL OLEA EUROPAEA (OLIVE) FRUIT OIL TOCOPHEROL RICINUS COMMUNIS (CASTOR) SEED OIL BHT LIMONENE, (+)- VANILLIN MENTHA PIPERITA (PEPPERMINT) OIL MENTHOL CI 15850 CI 77492 CI 77499"
      ],
      "active_ingredient": [
        "Active Ingredients Avobenzone 3% Octinoxate 5% Octocrylene 4.7%"
      ],
      "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": [
        "Stop use and ask doctor if - rash occur"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children if swallowed , call a poison control centre or get medical help right away"
      ],
      "dosage_and_administration": [
        "Directions * Apply liberally 15 minutes before sun exposure * Reapply at least every 2 hours • Use a water resistant sunscreen if swimming or sweating * 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 10a.m.- 2p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses • Children under 6 months of age: Ask a doctor"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Lanolin, Theobroma Cacao (Cocoa) Seed Butter, Cera Alba, Ricinus Communis (Castor) Seed Oil, Butyrospermum Parkii (Shea) Butter, Helianthus Annuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Flavour, Caprylic/Capric Triglyceride, Tocopherol, Myrothamnus Flabellifolia Leaf/Stem Extract, BHT, Limonene, Vanillin, Mentha Piperta Oil, Menthol, Titanium Dioxide (Cl 77891), Red 7 Lake (CI 15850), Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499)"
      ],
      "other_safety_information": [
        "Other Information Protect this product from excessive heat and direct sun"
      ],
      "package_label_principal_display_panel": [
        "ULTRA VIOLETTE SHEEN SCREEN SPF 50 Hydrating Lip Balm The Ultimate Everyday Lip Protector DUSK Broad Spectrum SPF 50 15g 0.5oz PDP"
      ],
      "set_id": "2735ab0f-5eec-04c5-e063-6394a90aa60e",
      "id": "5a0e9ed0-8900-f1b7-e063-6394a90abe9f",
      "effective_time": "20261001",
      "version": "5",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk"
        ],
        "generic_name": [
          "SPF50"
        ],
        "manufacturer_name": [
          "Grace And Fire USA Inc."
        ],
        "product_ndc": [
          "84803-104"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OCTINOXATE",
          "AVOBENZONE",
          "OCTOCRYLENE"
        ],
        "spl_id": [
          "5a0e9ed0-8900-f1b7-e063-6394a90abe9f"
        ],
        "spl_set_id": [
          "2735ab0f-5eec-04c5-e063-6394a90aa60e"
        ],
        "package_ndc": [
          "84803-104-01",
          "84803-104-02"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "4Y5P7MUD51",
          "G63QQF2NOX",
          "5A68WGF6WM"
        ]
      }
    }
  ]
}