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

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, JO COSMETICS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59427-704
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.0 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
LAUROYL LYSINE (UNII: 113171Q70B)
CELLULOSE ACETATE (UNII: 3J2P07GVB6)
DIMETHICONE (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59427-704-01	1 in 1 CARTON
1	NDC: 59427-704-02	8 g in 1 CASE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2010

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

Establishment
Name	Address	ID/FEI	Business Operations
JO COSMETICS		692780372	manufacture