{
  "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": "2026-10-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Coppertone Waterbabies Sunscreen SPF 50 Avobenzone 3%, Homosalate 9%, Octisalate 4.5%, Octocrylene 9% STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) DISODIUM EDTA-COPPER NEOPENTYL GLYCOL DIHEPTANOATE 1,2-HEXANEDIOL POTASSIUM HYDROXIDE WATER DIMETHYL ETHER ALOE VERA LEAF ALKYL (C12-15) BENZOATE HYDROXYACETOPHENONE CARBOMER INTERPOLYMER TYPE C (ALLYL SUCROSE CROSSLINKED) TOCOPHEROL VINYLPYRROLIDONE/EICOSENE COPOLYMER OCTOCRYLENE OCTOCRYLENE OCTISALATE OCTISALATE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Other information ■ protect this product from excessive heat and direct sun ■ store between 20˚ to 25˚C (68˚ to 77˚F) ■ may stain or damage some fabrics or surfaces"
      ],
      "active_ingredient": [
        "Active ingredients (To Deliver) Avobenzone 3%, Homosalate 9%, Octisalate 4.5%, Octocrylene 9%"
      ],
      "purpose": [
        "Purpose Sunscreen"
      ],
      "indications_and_usage": [
        "Use ■ helps prevent sunburn"
      ],
      "warnings": [
        "Warnings For external use only Flammable: Do not use near heat, flame, or while smoking"
      ],
      "do_not_use": [
        "Do not use on damaged or broken skin"
      ],
      "when_using": [
        "When using this product ■ keep away from face to avoid breathing it ■ keep out of eyes. Rinse with water to remove. ■ use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal. ■ do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120˚F."
      ],
      "stop_use": [
        "Stop use and ask a doctor if rash occurs"
      ],
      "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."
      ],
      "dosage_and_administration": [
        "Directions ■ shake well before each use ■ spray liberally and spread evenly by hand 15 minutes before sun exposure ■ hold container 4 to 6 inches from the skin to apply ■ do not spray directly into face. Spray on hands then apply to face. ■ do not apply in windy conditions ■ use in a well-ventilated area ■ reapply: ■ after 80 minutes of swimming or sweating ■ immediately after towel drying ■ 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 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-sleeve shirts, pants, hats, and sunglasses ■ children under 6 months: Ask a doctor"
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, dimethyl ether, aloe barbadensis leaf juice, C12-15 alkyl benzoate, neopentyl glycol diheptanoate, butylene glycol, styrene/acrylates copolymer, VP/eicosene copolymer, 1,2-hexanediol, hydroxyacetophenone, fragrance, tocopherol, acrylates/C10-30 alkyl acrylate crosspolymer, potassium hydroxide, disodium EDTA"
      ],
      "questions": [
        "Questions? 1-866-288-3330"
      ],
      "package_label_principal_display_panel": [
        "Coppertone ® Sunscreen Lotion Spray #1 Pediatrician Recommended Sunscreen Brand water babies 50 Hypoallergenic With Aloe and Nourishing Vitamin E Free of Oxybenzone, Octinoxate, Dyes & PABA Water Resistant (80 Minutes) Broad Specturm SPF 50 WB Lotion Spray"
      ],
      "set_id": "d53e1253-f6a4-4f3d-e053-2a95a90a79ed",
      "id": "4746f008-cb1b-e19b-e063-6394a90aadee",
      "effective_time": "20251231",
      "version": "4",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Coppertone Waterbabies Sunscreen SPF 50"
        ],
        "generic_name": [
          "AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%"
        ],
        "manufacturer_name": [
          "Beiersdorf Inc"
        ],
        "product_ndc": [
          "66800-4232"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OCTOCRYLENE",
          "OCTISALATE",
          "AVOBENZONE",
          "HOMOSALATE"
        ],
        "spl_id": [
          "4746f008-cb1b-e19b-e063-6394a90aadee"
        ],
        "spl_set_id": [
          "d53e1253-f6a4-4f3d-e053-2a95a90a79ed"
        ],
        "package_ndc": [
          "66800-4232-6",
          "66800-4232-9"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0072140027179"
        ],
        "unii": [
          "5A68WGF6WM",
          "4X49Y0596W",
          "G63QQF2NOX",
          "V06SV4M95S"
        ]
      }
    }
  ]
}