Label: CETAPHIL - octocrylene and avobenzone lotion

  • NDC Code(s): 0299-3928-04, 0299-3928-07
  • 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 05/11

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)

    • 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.

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  • Warnings

    For external use only
    Do not use on damaged or broken skin.
    Stop use and ask a doctor if rash occurs.
    When using this product keep out of eyes.
    Rinse with water to remove.

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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 liberally 15 minutes before sun exposure.
    • Use a water resistant sunscreen if swimming or sweating
    • Reapply at least every 2 hours.
    • Children under 6 months: ask a doctor
    SUN PROTECTION MEASURES: Spending time in the sun increases your risk of 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 10am – 2 pm.
    • Wear long-sleeved shirts, pants, hats, and sun glasses.

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  • INACTIVE INGREDIENTS:

    Water, Diisopropyl Adipate, Cyclomethicone, Glycerin, Glyceryl Steartae, 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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  • Other Information

    • Protect this product from excessive heat and direct sun.
    • May stain some fabrics.

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  • Questions?

    1-866-735-4137

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  • PRINCIPAL DISPLAY PANEL

    p50935-3-4oz-spf15-carton-v2

    Cetaphil®

    Every Age. Every Stage. Every Day.®

    Daily Facial
    Moisturizer

    with sunscreen

    BROAD SPECTRUM SPF 15

    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. Reapply as necessary throughout the day and before sun exposure.

    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.

    Distributed by:
    Galderma Laboratories, L.P.
    Fort Worth, Texas 76177 USA
    GALDERMA is a registered trademark
    Made in Canada
    cetaphil.com
    P50935-3

    10142-1014-cetaphil-men-dfl-crtn

    Cetaphil® MEN

    Daily Face Lotion

    with sunscreen

    BROAD SPECTRUM SPF 15

    Moisturizes and protects skin without clogging pores

    Dermatologist developed and tested

    4 FL OZ (118 mL)

    GALDERMA

    Cetaphil® MEN

    Daily Face Lotion

    with sunscreen

    BROAD SPECTRUM SPF 15

    Your face lotion should protect your skin from harsh outdoor elements and the effects of your razor.

    This lightweight formula absorbs quickly and locks in moisture to strengthen skin's natural moisture barrier. Perfect for post-shave, it soothes sensitive skin and helps defend skin from the sun's harmful rays to help prevent early signs of aging.

    The result is healthy, hydrated skin all day long...or all night long.

    Non-irritating. Won't clog pores. Unscented, Dermatologist developed and tested.

    Cetaphil® MEN

    Daily Face Lotion

    with sunscreen

    BROAD SPECTRUM SPF 15

    DIRECTIONS: Apply daily to face and neck, away from eyes. Reapply as necessary throughout the day and before sun exposure.

    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 help prevent sunburn and other skin damage.

    Use in combination with a complete regimen of Cetaphil cleansers and moisturizers for your daily skin care needs.

    Distributed by:

    Galderma Laboratories L.P.

    Fort Worth, TX 76177 USA

    GALDERMA is a registered trademark

    Made in Canada

    cetaphil.com

    10142-1014

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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:0299-3928-07 1 in 1 CARTON
    2 118 mL in 1 TUBE
    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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