{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "CERAMIDE PREMIERE BROAD SPECTRUM SPF 30 Octinoxate, Octisalate, Oxybenzone, Octocrylene, Avobenzone OXYBENZONE OXYBENZONE OCTINOXATE OCTINOXATE HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) CHOLESTEROL OCTOCRYLENE OCTOCRYLENE AVOBENZONE AVOBENZONE GLYCERIN PHYTOSPHINGOSINE ETHYLPARABEN POTASSIUM SORBATE POLYSORBATE 20 STANNIC OXIDE BUTYLOCTYL SALICYLATE XANTHAN GUM CERAMIDE 1 FUCUS SERRATUS EDETATE DISODIUM AMINO ACIDS, SOY BUTYLPHENYL METHYLPROPIONAL DIMETHICONE EDETIC ACID MICA WATER BUTYLENE GLYCOL MEDIUM-CHAIN TRIGLYCERIDES DIMETHYL CAPRAMIDE CERAMIDE 6 II OCTISALATE OCTISALATE PEG-100 STEARATE SODIUM DODECYLBENZENESULFONATE SODIUM HYDROXIDE PEG-8 LAURATE TRAMIPROSATE METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER AMINOPROPYL DIMETHICONE (1000 MPA.S) ISOMETHYL-.ALPHA.-IONONE HYDROXYCITRONELLAL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE PROPYLPARABEN METHYLPARABEN DOCOSANOL PHENOXYETHANOL DESMENINOL CALCIUM SODIUM BENZOATE TITANIUM DIOXIDE HYDROGENATED POLYBUTENE (1300 MW) PETROLATUM GLYCERYL MONOSTEARATE HYDROGENATED SOYBEAN LECITHIN CERAMIDE 3 YEAST"
      ],
      "active_ingredient": [
        "Active Ingredients Purpose Active Ingredients Purpose OCTINOXATE 7.5% ....... Sunscreen OCTISALATE 5.0%........ Sunscreen OXYBENZONE 4.0%........ Sunscreen OCTOCRYLENE 3.0%. ...... Sunscreen AVOBENZONE 2.0%....... Sunscreen"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients WATER/AQUA/EAU, DIMETHICONE, GLYCERIN, HYDROGENATED POLYISOBUTENE, PETROLATUM, GLYCERYL STEARATE, BUTYLENE GLYCOL, BUTYLOCTYL SALICYLATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETEARYL ALCOHOL, PEG-100 STEARATE, BUTYROSPERMUM PARKII (SHEA BUTTER), HYDROGENATED LECITHIN, DIMETHYL CAPRAMIDE, CERAMIDE 1, CERAMIDE 3, CERAMIDE 6 II, FUCUS SERRATUS EXTRACT, YEAST EXTRACT/FAEX/EXTRAIT DE LEVURE, RETINYL LINOLEATE, TOCOPHERYL ACETATE, CETEARYL DIMETHICONE CROSSPOLYMER, PEG-40 HYDROGENATED CASTOR OIL, SOY AMINO ACIDS, 3-AMINOPROPANE SULFONIC ACID, CALCIUM HYDROXYMETHIONINE, HYDROLYZED SOY PROTEIN, METHYL METHACRYLATE CROSSPOLYMER, PHYTOSPHINGOSINE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, CHOLESTEROL, SODIUM LAUROYL LACTYLATE, PEG-8 LAURATE, POLYSORBATE 20, SODIUM DODECYLBENZENESULFONATE, STYRENE/ACRYLATES COPOLYMER, BEHENYL ALCOHOL, PENTYLENE GLYCOL, CARBOMER, HYDROXYETHYLCELLULOSE, POLYETHYLENE, XANTHAN GUM, EDTA, SODIUM HYDROXIDE, BHT, DISODIUM EDTA, MICA, TIN OXIDE, AMINOPROPYL DIMETHICONE, FRAGRANCE/PARFUM, ALPHA-ISOMETHYL IONONE, BUTYLPHENYL METHYLPROPIONAL, CITRONELLOL, HYDROXYCITRONELLAL, ETHYLPARABEN, METHYLPARABEN, PHENOXYETHANOL, POTASSIUM SORBATE, PROPYLPARABEN, SODIUM BENZOATE, TITANIUM DIOXIDE (CI 77891)."
      ],
      "instructions_for_use": [
        "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 product is swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "when_using": [
        "Directions For Sunscreen Use - Apply liberally 15 minutes before sun exposure - Reapply: - at least every 2 hours - 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 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-sleeve shirts, pants, hats, and sunglasses - Children under 6 months: Ask a doctor."
      ],
      "dosage_and_administration": [
        "Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours"
      ],
      "indications_and_usage": [
        "Helps prevent sunburn If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin againg caused by the sun"
      ],
      "keep_out_of_reach_of_children": [
        "Keep Out of Reach of Children . If product is swallowed, get medical help or contact a poison control center right away."
      ],
      "purpose": [
        "Sunscreen"
      ],
      "package_label_principal_display_panel": [
        "Artwork premier carton"
      ],
      "set_id": "b3358bfd-7fe5-33e2-e053-2a95a90ac2ea",
      "id": "471d8a24-eac2-ccb8-e063-6294a90aa3ec",
      "effective_time": "20251229",
      "version": "3",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "CERAMIDE PREMIERE BROAD SPECTRUM SPF 30"
        ],
        "generic_name": [
          "OCTINOXATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONE"
        ],
        "manufacturer_name": [
          "REVLON"
        ],
        "product_ndc": [
          "10967-669"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OXYBENZONE",
          "OCTINOXATE",
          "OCTOCRYLENE",
          "AVOBENZONE",
          "OCTISALATE"
        ],
        "spl_id": [
          "471d8a24-eac2-ccb8-e063-6294a90aa3ec"
        ],
        "spl_set_id": [
          "b3358bfd-7fe5-33e2-e053-2a95a90ac2ea"
        ],
        "package_ndc": [
          "10967-669-17"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "95OOS7VE0Y",
          "4Y5P7MUD51",
          "5A68WGF6WM",
          "G63QQF2NOX",
          "4X49Y0596W"
        ]
      }
    }
  ]
}