Label: COPPERTONE DEFEND AND CLEAR- octinoxate, octisalate, zinc oxide lotion

  • NDC Code(s): 66800-3641-3, 66800-3641-6
  • Packager: Beiersdorf Inc
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 16, 2023

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  • Drug Facts

    Active ingredients

    Octinoxate 7.5%, Octisalate 4.5%, Zinc Oxide 9.7%

  • Purpose


    Sunscreen

  • Use

    helps prevent sunburn

  • 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.

  • Directions

    ■ shake well before use

    ■ apply liberally 15 minutes before sun exposure

    ■ 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

  • Other information

    ■ protect this product from excessive heat and direct sun

    ■ may stain or damage some fabrics or surfaces

  • Inactive ingredients

    water, dicaprylyl ether, glycerin, polyester-27,styrene/acrylates copolymer, trilaureth-4phosphate,cetearylalcohol,beeswax,dimethicone, ammonium acryloyldimethyltaurate/VP copolymer, benzyl alcohol,glyceryl stearate, triethoxycaprylylsilane, chlorphenesin, disodium EDTA

  • Questions?

    1-866-288-3330

  • Principal Display Panel

    Coppertone Sunscreen Lotion

    Clear Zince FACE

    with Zinc Oxide

    Defend & Care

    Lightweight No White Residue

    Free of oxybenzone, dyes & PABA

    Water Resistant (80 Minutes)

    Broad Specturm SPF 50

    3 FL OZ (88 mL)

    DC_Clear Zinc Face

  • INGREDIENTS AND APPEARANCE
    COPPERTONE DEFEND AND CLEAR 
    octinoxate, octisalate, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66800-3641
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE9.7 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    WATER (UNII: 059QF0KO0R)  
    STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
    TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)  
    SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
    POLYESTER-7 (UNII: 0841698D2F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66800-3641-388 g in 1 TUBE; Type 0: Not a Combination Product11/02/2020
    2NDC:66800-3641-6177 g in 1 TUBE; Type 0: Not a Combination Product11/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/02/2020
    Labeler - Beiersdorf Inc (001177906)
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