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Name:A Perfect Worldspf 35 Uv Face Protector
Manufacturer:Origins Natural Resources Inc
Category:Over-the-counter (OTC) Marketed Drugs


A PERFECT WORLD SPF 35 UV FACE PROTECTOR - homosalate, octisalate, avobenzone and octocrylene lotion 
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: homosalate 5.00% [] octisalate 5.00% [] avobenzone 3.00% [] octocrylene 2.70%

inactive ingredients: water; citrus aurantium amara (bitter orange) flower water, anthemis nobilis (chamomile) flower water [] butyloctyl salicylate [] methyl trimethicone [] jojoba esters [] polyester-8 [] ethyl macadamiate [] lauryl peg-9 polydimethylsiloxyethyl dimethicone [] butylene glycol [] peg-100 stearate [] glyceryl stearate [] citrus aurantium bergamia (bergamot) fruit oil*, citrus medica limonum (lemon) peel oil*, citrus aurantium dulcis (orange) oil*, cinnamomum camphora (camphor) bark oil*, mentha viridis (spearmint) leaf oil*, magnolia acuminata flower extract, iris pallida (orris) root extract, rosa damascena (rose) extract, citral, linalool, limonene [] camellia sinensis (white tea) leaf extract [] pinus pinaster bark/bud extract [] arabidopsis thaliana extract [] ascorbyl tocopheryl maleate [] oryzanol [] ergothioneine [] triticum vulgare (wheat) germ extract [] laminaria saccharina extract [] mangifera indica (mango) seed butter [] butyrospermum parkii (shea butter) [] potassium cetyl phosphate [] caffeine [] cholesterol [] linoleic acid [] hordeum vulgare (barley) extract\extrait d'orge [] cetyl alcohol [] ethylhexylglycerin [] trioctyldodecyl citrate [] lecithin [] squalane [] dehydroxanthan gum [] caprylyl glycol [] sodium hyaluronate [] ammonium acryloyldimethyltaurate/vp copolymer [] silica [] sodium stearate [] citric acid [] sodium dehydroacetate [] phenoxyethanol [] mica [] iron oxides (ci 77491, ci 77492, ci 77499)

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

keep out of reach of children.

principal display panel:


ORIGINS

A PERFECT WORLD

SPF 35

UV FACE PROTECTOR WITH WHITE TEA


1.4 fl oz/oz liq /40 ml




origins natural resources dist.
new york, ny 10022

folding carton




A PERFECT WORLD  SPF 35 UV FACE PROTECTOR
homosalate, octisalate, avobenzone, octocrylene lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59427-706
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE (HOMOSALATE) HOMOSALATE 5.0 mL  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE 5.0 mL  in 100 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE 3.0 mL  in 100 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 2.7 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
METHYL TRIMETHICONE  
BUTYLENE GLYCOL  
GLYCERYL MONOSTEARATE  
CHOLESTEROL  
LECITHIN, SOYBEAN  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59427-706-01 1 TUBE ( TUBE) in 1 CARTON contains a TUBE (59427-706-02)
1 NDC:59427-706-02 40 mL in 1 TUBE This package is contained within the CARTON (59427-706-01)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 09/01/2010

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

Revised: 01/2011 ORIGINS NATURAL RESOURCES INC



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


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