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

BRIGHTER BY NATURE by

Drug Labeling and Warnings

BRIGHTER BY NATURE by is a Otc medication manufactured, distributed, or labeled by ORIGINS NATURAL RESOURCES INC, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER N.V., Len-Ron Manufacturing Division of Aramis Inc., Aramis Inc., Northtec Bristol, Northtec Keystone, Estee Lauder Pennsylvania Distribution Center 2, Estee Lauder Cosmetics, Ltd., Estee Lauder Cosmetics, Ltd, Estee Lauder Cosmetics Distribution Center, Estee Lauder Kabushiki Kaisha, Whitman Laboratories Ltd., Aveda Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Product 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