Label: CETAPHIL - octocrylene and avobenzone lotion

  • NDC Code(s): 0299-3928-02, 0299-3928-04
  • Packager: Galderma Laboratories, L.P.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

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

  • Active Ingredients

    Avobenzone 3%
    Octocrylene 10%

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  • Purpose

    Avobenzone..........Sunscreen
    Octocrylene..........Sunscreen

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  • Use(s)

    Filters out the sun's harmful rays to help prevent:

    • skin damage
    • freckling
    • uneven coloration
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  • Warnings

    For external use only, not to be swallowed

    When using this product

    • avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a doctor if

    • signs of irritation or rash appear and persist.
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  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    • Apply daily to face and neck, away from eyes.
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  • Other Information

    • Moderate Sun Protection Product.
    • SUN ALERT: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
    • May stain some fabrics.
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  • INACTIVE INGREDIENT SECTION

    Water, Diisopropyl Adipate, Cyclomethicone, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Polymethyl Methacrylate, Phenoxyethanol, Benzyl Alcohol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Carbomer 940, Disodium EDTA, Triethanolamine

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  • PRINCIPAL DISPLAY PANEL

    Carton

    Cetaphil®

    Every Age. Every Stage. Every Day.®

    Daily Facial
    Moisturizer

    SPF15

    FOR ALL SKIN TYPES

    Non-comedogenic
    Lightweight, non-greasy
    Fragance free

    UVA/UVB Protection

    4 FL OZ (118 mL)

    GALDERMA

    This light, non-greasy moisturizer nourishes and hydrates your skin while also protecting it from the sun's harmful rays.

    Restores and improves your skin's ability to retain vital moisture.

    Non-comedogenic
    PABA free / Fragrance free
    Dermatologist recommended

    DIRECTIONS: Apply daily to face and neck, away from eyes.

    Importance of daily sunscreen protection:

    UV rays from the sun are made of UVA and UVB. It is important to protect against both UVA and UVB to prevent sunburn and other skin damage.

    Use in conbination with a complete regimen of Cetaphil® Cleansers and Moisturizers for you daily skin care needs.

    Marketed by:
    Galderma Laboratories, L.P.
    Fort Worth, Texas 76177 USA
    GALDERMA is a registered trademark
    Made in Canada
    cetaphil.com
    P50935-2

    Sample

    Cetaphil®

    Daily Facial
    Moisturizer

    SPF15

    UVA/UVB Protection
    Non-comedogenic

    .25 FL OZ (7 mL)

    USE: Sunscreen

    ACTIVE INGREDIENTS:
    AVOBENZONE 3%,
    OCTOCRYLENE 10%

    DIRECTIONS: Apply daily to face and neck, away from eyes.

    Marketed by:
    Galderma® Laboratories, L.P.
    Fort Worth, Texas 76177 USA
    Made in Canada
    cetaphil.com
    SAMPLE, NOT FOR SALE

    P50928-2

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  • INGREDIENTS AND APPEARANCE
    CETAPHIL  
    octocrylene, avobenzone lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0299-3928
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Octocrylene (Octocrylene) Octocrylene 10 g  in 100 mL
    Avobenzone (Avobenzone) Avobenzone 3 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Diisopropyl Adipate  
    Cyclomethicone  
    Glycerin  
    Glyceryl Monostearate  
    Polyoxyl 100 Stearate  
    Phenoxyethanol  
    Benzyl Alcohol  
    Carbomer Copolymer Type A  
    Carbomer Homopolymer Type C  
    Edetate Disodium  
    Trolamine  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0299-3928-04 1 in 1 CARTON
    1 118 mL in 1 TUBE
    2 NDC:0299-3928-02 4 mL in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 04/01/2000
    Labeler - Galderma Laboratories, L.P. (047350186)
    Establishment
    Name Address ID/FEI Business Operations
    G Production Inc. 251676961 MANUFACTURE(0299-3928)
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