Label: COPPERTONE CLEARLY SHEER WHIPPED SUNSCREEN BROAD SPECTRUM SPF 30 SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion

  • NDC Code(s): 23667-801-01
  • Packager: Formulated Solutions, LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 2, 2023

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  • Drug Facts

  • Active ingredients

    (To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 4.5%,
    Octocrylene 8%

    Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection increases (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
  • 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.
    • use only as directed. Intentional misue 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 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.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • do not dispense or apply directly on face. Dispense into hands and apply to face
    • use in well-ventillated areas
    • reapply:
    • after 80 minutes if swimming or sweating
    • imediately 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 sunscereen 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
  • Other Information

    • protect this product from excessive heat and direct sun
    • avoid long term storage above 40°C (104°F)
    • may stain or damage some fabrics or surfaces
  • Inactive ingredients

    Water, Aluminum Starch Octenylsuccinate, Behenyl Alcohol, Glycerin, Styrene/Acrylates Copolymer, Dicaprylyl Ether, Microcrystalline Cellulose, Glyceryl Stearate, Cetyl Alcohol, Benzyl Alcohol, Butylated PVP, Palmitic Acid, Stearic Acid, Myristyl Alcohol, Chlorphenesin, Tocopherol (Vitamin E), Cellulose Gum, Lecithin, Disodium EDTA, Lauryl Alcohol, Sodium Ascorbyl Phosphate, Fragrance, Nitrous Oxide.

  • Questions?

    1-866-288-330

  • Package Labeling:

    Coppertone 30

  • INGREDIENTS AND APPEARANCE
    COPPERTONE CLEARLY SHEER WHIPPED SUNSCREEN BROAD SPECTRUM SPF 30  SPF 50
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:23667-801
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE80 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    WATER (UNII: 059QF0KO0R)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    LAURYL ALCOHOL (UNII: 178A96NLP2)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    NITROUS OXIDE (UNII: K50XQU1029)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23667-801-01142 g in 1 CAN; Type 0: Not a Combination Product02/09/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02002/09/2017
    Labeler - Formulated Solutions, LLC (143266687)
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