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Name:Brighter By Naturespf 30 Skin Tone Correcting Makeup
Manufacturer:Origins Natural Resources Inc
Category:Over-the-counter (OTC) Marketed Drugs


BRIGHTER BY NATURE SPF 30 SKIN TONE CORRECTING MAKEUP - octinoxate, titanium dioxide and octocrylene powder 
ORIGINS NATURAL RESOURCES INC

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.

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

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)

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


keep out of reach of children

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


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 DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 g  in 100 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 3.0 g  in 100 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 1.0 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
MICA  
LAUROYL LYSINE  
CELLULOSE ACETATE  
DIMETHICONE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59427-704-01 1 CASE ( CASE) in 1 CARTON contains a CASE (59427-704-02)
1 NDC:59427-704-02 8 g in 1 CASE This package is contained within the CARTON (59427-704-01)

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 Operations
ESTEE LAUDER COSMETICS, LTD 205952385 manufacture
Establishment
Name Address ID/FEI Operations
ESTEE LAUDER N.V. 370151326 manufacture
Establishment
Name Address ID/FEI Operations
Len-Ron Manufacturing Division of Aramis Inc. 809771152 manufacture
Establishment
Name Address ID/FEI Operations
Aramis Inc. 042918826 manufacture
Establishment
Name Address ID/FEI Operations
Northtec Bristol 949264774 manufacture, relabel, repack
Establishment
Name Address ID/FEI Operations
Northtec Keystone 618107429 manufacture, relabel, repack
Establishment
Name Address ID/FEI Operations
Estee Lauder Pennsylvania Distribution Center 2 828534516 manufacture, relabel, repack
Establishment
Name Address ID/FEI Operations
Estee Lauder Cosmetics, Ltd. 255175580 manufacture
Establishment
Name Address ID/FEI Operations
Estee Lauder Cosmetics, Ltd 253616536 manufacture
Establishment
Name Address ID/FEI Operations
Estee Lauder Cosmetics Distribution Center 208579636 repack, relabel
Establishment
Name Address ID/FEI Operations
Estee Lauder Kabushiki Kaisha 712808195 relabel, repack
Establishment
Name Address ID/FEI Operations
Whitman Laboratories Ltd. 216866277 manufacture
Establishment
Name Address ID/FEI Operations
Aveda Corporation 071352058 manufacture
Establishment
Name Address ID/FEI Operations
JO COSMETICS 692780372 manufacture

Revised: 11/2010 ORIGINS NATURAL RESOURCES INC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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