Label: BRIGHTER BY NATURE SPF 35 SKIN TONE CORRECTING MOISTURIZER- homosalate, octisalate, avobenzone, octocrylene lotion
-
Contains inactivated NDC Code(s)
NDC Code(s): 59427-703-01, 59427-703-02 - Packager: ORIGINS NATURAL RESOURCES INC
- 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 15, 2010
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
-
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
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BRIGHTER BY NATURE SPF 35 SKIN TONE CORRECTING MOISTURIZER
homosalate, octisalate, avobenzone, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59427-703 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5.0 mL in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.0 mL in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3.0 mL in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.7 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) METHYL TRIMETHICONE (UNII: S73ZQI0GXM) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59427-703-01 1 in 1 CARTON 1 NDC:59427-703-02 50 mL in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/01/2010 Labeler - ORIGINS NATURAL RESOURCES INC (611716283) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 205952385 manufacture Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 manufacture Establishment Name Address ID/FEI Business Operations Len-Ron Manufacturing Division of Aramis Inc. 809771152 manufacture Establishment Name Address ID/FEI Business Operations Aramis Inc. 042918826 manufacture Establishment Name Address ID/FEI Business Operations Northtec Bristol 949264774 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Northtec Keystone 618107429 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 828534516 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics, Ltd. 255175580 manufacture Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics, Ltd 253616536 manufacture Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Distribution Center 208579636 repack, relabel Establishment Name Address ID/FEI Business Operations Estee Lauder Kabushiki Kaisha 712808195 relabel, repack Establishment Name Address ID/FEI Business Operations Whitman Laboratories Ltd. 216866277 manufacture Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 manufacture