Label: CETAPHIL - octocrylene, 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

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 29, 2016

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 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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  • 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

    p50935-5-spf15-4oz

    Cetaphil®

    Daily Facial
    Moisturizer

    with sunscreen

    BROAD SPECTRUM SPF 15

    Face All skin types

    Hydrates, nourishes and protects

    UVA/UVB Protection

    Non-comedogenic

    Fragrance free

    Lightweight, non-greasy

    4 FL OZ (118mL)

    Cetaphil

    Daily Facial

    Moisturizer

    with sunscreen

    BROAD SPECTRUM

    SPF 15

    FOR ALL SKIN TYPES

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

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

    Non-comedogenic

    Fragrance free / PABA free

    Dermatologist recommended

    Actual size

    Cetaphil

    Daily Facial

    Moisturizer

    with sunscreen

    BROAD SPECTRUM

    SPF 15

    FOR ALL SKIN TYPES

    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. Also, broad spectrum sunscreen protection helps decrease early signs of aging caused by the sun when used with other sun protection measures.

    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, Texas 76177 USA

    Cetaphil is a registered trademark of Galderma.


    Made in Canada

    cetaphil.com
    P50935-5

    LOT:

    EXP:

    p52883-0-mens-carton

    Cetaphil®

    MEN

    Daily Face Lotion

    with sunscreen

    BROAD SPECTRUM SPF 15

    Face • For all skin types

    Soothes sensitive skin even post-shave

    Hydrates and protects skin without clogging pores

    4 FL OZ (118 mL)

    Cetaphil MEN

    Daily Face Lotion

    with sunscreen

    BROAD SPECTRUM

    SPF 15

    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.  Broad spectrum SPF 15 protection helps decrease early signs of aging caused by the sun when used with other sun protection measures. Perfect for post-shave, it also soothes sensitive skin. The result is healthy, hydrated skin all day or night long. Use after cleansing with Cetaphil Men Daily Face Wash.

    Won't clog pores.

    Non-irritating.

    No fragrance.

    Dermatologist developed and tested.

    Actual Size

    Cetaphil® MEN

    Daily Face Lotion

    with sunscreen

    BROAD SPECTRUM

    SPF 15

    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.

    Distributed by:

    Galderma Laboratories L.P.

    Fort Worth, TX 76177 USA

    CETAPHIL is a registered trademark of GALDERMA.

    Made in Canada

    cetaphil.com
    P52833-0

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  • INGREDIENTS AND APPEARANCE
    CETAPHIL  
    octocrylene, avobenzone lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0299-3928
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    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 BOTTLE, PUMP; Type 0: Not a Combination Product
    2 NDC:0299-3928-07 1 in 1 CARTON
    2 118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    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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