Label: BRIGHTER BY NATURE SPF 30 SKIN TONE CORRECTING MAKEUP- octinoxate, titanium dioxide, octocrylene powder

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 November 17, 2010

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  • ACTIVE INGREDIENT

     active ingredients: octinoxate 7.50% [] titanium dioxide 3.00% [] octocrylene 1.00%

  • INACTIVE INGREDIENT

    inactive ingredients: mica [] lauroyl lysine [] cellulose acetate [] dimethicone [] ascorbyl palmitate [] rosmarinus officinalis (rosemary) extract [] punica granatum (pomegranate) juice extract [] sanguisorba officinalis (burnet) root extract [] curcuma longa (turmeric) root extract [] caprylyl methicone [] methicone [] ethylhexylglycerin [] caffeine [] oryzanol [] isostearyl sebacate [] disodium stearoyl glutamate [] pentylene glycol [] zinc myristate [] silica [] glycyrrhetinic acid [] alumina [] 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*, limonene, linalool [] phenoxyethanol []  [+/- iron oxides (ci 77491, ci 77492, ci 77499) [] titanium dioxide (ci 77891)

  • 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 30

    SKIN TONE CORRECTING MAKEUP



    NET WT. 0.28 OZ/ 8 GM



    ORIGINS NATURAL RESOURCES INC, DISTR

    NEW YORK, NY 10022

    folding carton

  • INGREDIENTS AND APPEARANCE
    BRIGHTER BY NATURE  SPF 30 SKIN TONE CORRECTING MAKEUP
    octinoxate, titanium dioxide, octocrylene powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59427-704
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.0 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    CELLULOSE ACETATE (UNII: 3J2P07GVB6)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59427-704-011 in 1 CARTON
    1NDC:59427-704-028 g in 1 CASE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2010
    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
    Establishment
    NameAddressID/FEIBusiness Operations
    JO COSMETICS692780372manufacture
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