Label: COPPERTONE 5X UV PROTECT FACE SUNSCREEN- avobenzone 3%, homosalate 9%, octisalate 4.5%, octocrylene 9% lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated January 10, 2024

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

  • Drug Facts

  • Active ingredients

    Avobenzone 3%, Homosalate 9%, Octisalate 4.5%, Octocrylene 9%

  • Purpose

    Sunscreen

  • 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

    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.

  • 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.

  • Directions

    ■ 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, C12-15 alkyl benzoate, neopentyl glycol diheptanoate, styrene/acrylates copolymer, butylene glycol, diethylhexyl syringylidenemalonate, VP/Eicosene copolymer, 1,2-hexanediol, hydroxyacetophenone, aloe barbadensis leaf juice, tocopherol, acrylates/C10-30 alkyl acrylate crosspolymer, potassium hydroxide, disodium EDTA, sodium ascorbyl phosphate

  • Questions?

    1-866-288-3330

  • PRINCIPAL DISPLAY PANEL

    Coppertone Sunscreen Lotion

    UV Protect

    Face

    SPF 50+ PA+++

    5X

    UVA/UVB Protection

    Anti Photo-aging

    Light Weight

    Oil Free

    Hydrates Skin

    Water Resistant (80 Minutes)

    Broad Spectrum SPF 50+

    UV 5X

  • INGREDIENTS AND APPEARANCE
    COPPERTONE 5X UV PROTECT FACE SUNSCREEN 
    avobenzone 3%, homosalate 9%, octisalate 4.5%, octocrylene 9% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66800-0067
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE9 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE9 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)  
    WATER (UNII: 059QF0KO0R)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    Product Characteristics
    Colorwhite (White to Off-White) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66800-0067-274 g in 1 TUBE; Type 0: Not a Combination Product11/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only11/01/2023
    Labeler - Beiersdorf Inc (001177906)