NUDE AND IMPROVED BARE FACE MAKEUP SPF 15- titanium dioxide 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 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

folding carton

NUDE AND IMPROVED BARE FACE MAKEUP  SPF 15
titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59427-761
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7.6 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
LAURIC ACID (UNII: 1160N9NU9U)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LEVOMENOL (UNII: 24WE03BX2T)  
SOY STEROL (UNII: PL360EPO9J)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
DIMETHICONOL (250000 MW) (UNII: RKI3S914RT)  
PEG-12 STEARATE (UNII: 9KU38O8CEK)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FERROUS OXIDE (UNII: G7036X8B5H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59427-761-021 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/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD205952385manufacture
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326manufacture
Establishment
NameAddressID/FEIBusiness Operations
Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aramis Inc.042918826manufacture
Establishment
NameAddressID/FEIBusiness Operations
Northtec Bristol949264774manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Northtec Keystone618107429manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd.255175580manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd253616536manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Distribution Center208579636repack, relabel
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Kabushiki Kaisha712808195relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Whitman Laboratories Ltd.216866277manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058manufacture

Revised: 7/2011
Document Id: 9f603ab9-c46c-4600-ae58-808fe6d6d6bb
Set id: 781d3b6d-10da-4671-a265-a6952dfa2acd
Version: 1
Effective Time: 20110728
 
ORIGINS NATURAL RESOURCES INC.