Label: BRIGHTER BY NATURE SPF 35 SKIN TONE CORRECTING MOISTURIZER- homosalate, octisalate, avobenzone, octocrylene lotion

  • Category: HUMAN OTC DRUG LABEL

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 November 15, 2010

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  • ACTIVE INGREDIENT

    active ingredients: homosalate 5.00% [] octisalate 5.00% [] avobenzone 3.00% [] octocrylene 2.70%

  • INACTIVE INGREDIENT

    inactive ingredients: water\aqua\eau; citrus aurantium amara (bitter orange) flower water, anthemis nobilis (chamomile) flower water [] butyloctyl salicylate [] methyl trimethicone [] jojoba esters [] butylene glycol [] polyester-8 [] ethyl macadamiate [] lauryl peg-9 polydimethylsiloxyethyl dimethicone [] peg-100 stearate [] butyrospermum parkii (shea butter) [] glyceryl stearate [] citrus aurantifolia (lime) oil*, citrus grandis (grapefruit) peel oil*, cymbopogon schoenanthus (lemongrass) oil*, mentha viridis (spearmint) leaf oil*, salvia sclarea (clary sage) oil*, ormenis multicaulis (chamomile) oil*, pelargonium graveolens (geranium) flower oil*,  lavandula angustifolia (lavender) oil*, thymus vulgaris (thyme) oil*, coriandrum sativum (coriander) fruit oil*, citral, geraniol, linalool, citronellol, limonene [] gentiana lutea (gentian) root extract [] hordeum vulgare (barley) extract\extrait d'orge [] paeonia albiflora (peony) root extract [] sanguisorba officinalis (burnet) root extract [] cucumis sativus (cucumber) fruit extract [] perilla ocymoides leaf extract [] pyrus malus (apple) fruit extract [] hydrolyzed rice bran extract [] scutellaria baicalensis root extract [] triticum vulgare (wheat) germ extract [] polygonum tinctorium leaf/stem extract [] curcuma longa (turmeric) root extract [] palmaria palmata extract [] trametes versicolor extract [] sodium grape seed extract phosphate [] micrococcus lysate [] mangifera indica (mango) seed butter [] silica [] potassium cetyl phosphate [] cetyl alcohol [] ethylhexylglycerin [] arginine [] ascorbyl glucoside [] caffeine [] salicylic acid [] cholesterol [] behenyl alcohol [] tocotrienols [] linoleic acid [] sodium hyaluronate [] squalane [] magnesium ascorbyl phosphate [] phospholipids [] ammonium acryloyldimethyltaurate/vp copolymer [] caprylyl glycol [] tocopheryl acetate [] glycyrrhetinic acid [] dehydroxanthan gum [] sodium stearate [] sodium dehydroacetate [] phenoxyethanol [] mica

  • WARNINGS

    warning: keep out of eyes. stop use if irritation occurs.

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • PRINCIPAL DISPLAY PANEL

    ORIGINS

    BRIGHTER BY NATURE SPF 35

    SKIN TONE CORRECTING MOISTURIZER



    NET WT. 1.7 OZ/50 ML

    ORIGINS NATURAL RES., DIST
    NEW YORK, NY 10022

    FOLDING CARTON



  • INGREDIENTS AND APPEARANCE
    BRIGHTER BY NATURE  SPF 35 SKIN TONE CORRECTING MOISTURIZER
    homosalate, octisalate, avobenzone, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59427-703
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5.0 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.0 mL  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3.0 mL  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.7 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59427-703-011 in 1 CARTON
    1NDC:59427-703-0250 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/01/2010
    Labeler - ORIGINS NATURAL RESOURCES INC (611716283)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD205952385manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER N.V.370151326manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Aramis Inc.042918826manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Northtec Bristol949264774manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Northtec Keystone618107429manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics, Ltd.255175580manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics, Ltd253616536manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Distribution Center208579636repack, relabel
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Kabushiki Kaisha712808195relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Whitman Laboratories Ltd.216866277manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Aveda Corporation071352058manufacture
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