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
  • DEA Schedule: None

Drug Label Information

Updated November 14, 2024

If you are a consumer or patient please visit this version.

  • 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

    Do not use on damaged or broken skin

  • WHEN USING

    When using this product keep out of eyes. Rinse with water to remove.

  • WHEN USING

    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.

  • 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)

    DandC

  • 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
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100 g
    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
    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 DrugM02011/02/2020
    Labeler - Beiersdorf Inc (001177906)