Label: BRIGHTEN SPF 30- zinc oxide and octinoxate cream

  • 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 02/13

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

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    ZINC OXIDE 15%

    OCTINOXATE 6%

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  • PURPOSE

    PURPOSE

    SUNSCREEN

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  • INDICATIONS & USAGE

    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
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  • WARNINGS

    WARNINGS

    FOR EXTERNAL USE ONLY

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  • DO NOT USE

    DO NOT USE

    • On damaged or broken skin

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  • WHEN USING

    WHEN USING THIS PRODUCT

    • Keep out of eyes. Rinse with water to remove.
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  • STOP USE

    STOP USE AND ASK A DOCTOR IF TOO MUCH SKIN IRRITATION OR SENSITIVITY DEVELOPS OR INCREASES.

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

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  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    • Apply on to clean and dry face morning and night, avoiding the delicate eye area.
    • Apply 15 minutes before sun exposure. May be used daily.
    • Consult your physician before use.
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  • OTHER SAFETY INFORMATION

    Other Information

    • STORE AT 15-30°C (59-86°F)
    • PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.
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  • INACTIVE INGREDIENT

    INGREDIENTS

    aqua (water), cyclopentasiloxane, PEG-10 dimethicone, dimethicone, butylene glycol, cyclohexasiloxane, glycerin, corallina officinalis extract, algae extract, avena sativa (oat) kernel extract, angelica sinensis extract, 10-hydroxydecanoic acid, sebacic acid, 1,10-decanediol acid, betaine, dimethicone/vinyl dimethicone crosspolymer, lauryl PEG-9 polydimethylsiloxyethyl dimethicone, lecithin, dimethicone/PEG-10/15 crosspolymer, dimethicone/vinyl dimethicone crosspolymer, triethoxycaprylylsilane, decamethylcyclopentasiloxane, trifluoromethyl C1-C4 alkyl dimethicone, quaternium-90 bentonite, butylene glycol, sodium chloride, sodium citrate, ethylhexylglycerin, propylene carbonate, propylene glycol, potassium sorbate, methylisothiazolinone, iodopropynyl butylcarbamate, phenoxyethanol

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  • INGREDIENTS AND APPEARANCE
    BRIGHTEN  SPF 30
    zinc oxide octinoxate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54272-201
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 15 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CORALLINA OFFICINALIS (UNII: 4004498D06)  
    PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)  
    OAT (UNII: Z6J799EAJK)  
    ANGELICA SINENSIS WHOLE (UNII: 697D19QDBN)  
    10-HYDROXYDECANOIC ACID (UNII: NP03XO416B)  
    SEBACIC ACID (UNII: 97AN39ICTC)  
    1,10-DECANEDIOL (UNII: 5I577UDK52)  
    BETAINE (UNII: 3SCV180C9W)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    ALANINE (UNII: OF5P57N2ZX)  
    SERINE (UNII: 452VLY9402)  
    MAGNESIUM LACTATE (UNII: MT6QI8324A)  
    POTASSIUM LACTATE (UNII: 87V1KMK4QV)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SORBIC ACID (UNII: X045WJ989B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54272-201-11 30 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 02/21/2013
    Labeler - CEN BEAUTY LLC (078664118)
    Registrant - CEN BEAUTY LLC (078664118)
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