NUDE AND IMPROVED BARE FACE MAKEUP SPF 15

Dosage form: lotion
Ingredients: TITANIUM DIOXIDE 7.6mL in 100mL
Labeler: ORIGINS NATURAL RESOURCES INC.
NDC Code: 59427-761

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.

active ingredient: titanium dioxide 7.60%

inactive ingredients: water\aqua\eau; citrus aurantium amara (bitter orange) flower water [] cyclopentasiloxane [] octyldodecyl neopentanoate [] dimethicone [] ethylhexyl hydroxystearate [] butylene glycol [] glyceryl stearate [] polymethyl methacrylate [] silica [] talc [] polyglyceryl-2 sesquiisostearate [] quaternium-18 bentonite [] lauric acid [] ascorbyl palmitate [] tocopheryl acetate [] citrus medica limonum (lemon) peel oil*,  mentha viridis (spearmint) leaf oil*, citrus paradisi (grapefruit) fruit extract, limonene [] caprylyl glycol [] bisabolol [] glycine soja (soybean) sterols [] peg/ppg-18/18 dimethicone [] ethylhexylglycerin [] peg-10 dimethicone crosspolymer [] dimethiconol [] peg-12 distearate [] peg-10 dimethicone [] propylene carbonate [] polyglyceryl-4 isostearate [] hexyl laurate [] cetyl peg/ppg-10/1 dimethicone [] cellulose gum [] magnesium aluminum silicate [] barium sulfate [] alumina [] disodium edta [] bht [] phenoxyethanol []  [+/- mica [] titanium dioxide (ci 77891) [] 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

NUDE AND IMPROVED

BARE-FACE MAKEUP

WITH SPF 15

SUNSCREEN


1 fl oz liq/30 ml

origins natural resources inc

new york, ny 10022

NUDE AND IMPROVED BARE FACE MAKEUP  SPF 15
titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59427-761
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE7.6 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 5 
OCTYLDODECYL NEOPENTANOATE 
DIMETHICONE 
ETHYLHEXYL HYDROXYSTEARATE 
BUTYLENE GLYCOL 
GLYCERYL MONOSTEARATE 
SILICON DIOXIDE 
TALC 
LAURIC ACID 
ASCORBYL PALMITATE 
CITRUS AURANTIUM FLOWER OIL 
CAPRYLYL GLYCOL 
LEVOMENOL 
SOY STEROL 
ETHYLHEXYLGLYCERIN 
DIMETHICONOL (250000 MW) 
PEG-12 STEARATE 
PROPYLENE CARBONATE 
POLYGLYCERYL-4 ISOSTEARATE 
HEXYL LAURATE 
CARBOXYMETHYLCELLULOSE SODIUM 
BARIUM SULFATE 
ALUMINUM OXIDE 
EDETATE DISODIUM 
BUTYLATED HYDROXYTOLUENE 
PHENOXYETHANOL 
FERROUS OXIDE 
Packaging
#Item CodePackage Description
1NDC:59427-761-021 BOTTLE (BOTTLE) in 1 CARTON
1NDC:59427-761-0130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2002
Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD205952385manufacture
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER N.V.370151326manufacture
Establishment
NameAddressID/FEIOperations
Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
Establishment
NameAddressID/FEIOperations
Aramis Inc.042918826manufacture
Establishment
NameAddressID/FEIOperations
Northtec Bristol949264774manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Northtec Keystone618107429manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics, Ltd.255175580manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics, Ltd253616536manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics Distribution Center208579636repack, relabel
Establishment
NameAddressID/FEIOperations
Estee Lauder Kabushiki Kaisha712808195relabel, repack
Establishment
NameAddressID/FEIOperations
Whitman Laboratories Ltd.216866277manufacture
Establishment
NameAddressID/FEIOperations
Aveda Corporation071352058manufacture

Revised: 07/2011
 
ORIGINS NATURAL RESOURCES INC.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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