NUDE AND IMPROVED BARE FACE MAKEUP SPF 15 (TITANIUM DIOXIDE) LOTION [ORIGINS NATURAL RESOURCES INC.]

NUDE AND IMPROVED BARE FACE MAKEUP SPF 15 (TITANIUM DIOXIDE) LOTION [ORIGINS NATURAL RESOURCES INC.]
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NDC	59427-761-01, 59427-761-02
Set ID	781d3b6d-10da-4671-a265-a6952dfa2acd
Category	HUMAN OTC DRUG LABEL
Packager	ORIGINS NATURAL RESOURCES INC.
Generic Name
Product Class
Product Number
Application Number	PART352

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ACTIVE INGREDIENT

active ingredient: titanium dioxide 7.60%
INACTIVE INGREDIENT

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)]
WARNINGS

warning: keep out of eyes. stop use if irritation occurs. keep out of reach of children
PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

NUDE AND IMPROVED BARE FACE MAKEUP SPF 15
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59427-761
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	7.6 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59427-761-02	1 in 1 CARTON
1	NDC:59427-761-01	30 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/01/2002

Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COSMETICS, LTD		205952385	manufacture

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER N.V.		370151326	manufacture

Name	Address	ID/FEI	Business Operations
Establishment
Len-Ron Manufacturing Division of Aramis Inc.		809771152	manufacture

Name	Address	ID/FEI	Business Operations
Establishment
Aramis Inc.		042918826	manufacture

Name	Address	ID/FEI	Business Operations
Establishment
Northtec Bristol		949264774	manufacture, relabel, repack

Name	Address	ID/FEI	Business Operations
Establishment
Northtec Keystone		618107429	manufacture, relabel, repack

Name	Address	ID/FEI	Business Operations
Establishment
Estee Lauder Pennsylvania Distribution Center 2		828534516	manufacture, relabel, repack

Name	Address	ID/FEI	Business Operations
Establishment
Estee Lauder Cosmetics, Ltd.		255175580	manufacture

Name	Address	ID/FEI	Business Operations
Establishment
Estee Lauder Cosmetics, Ltd		253616536	manufacture

Name	Address	ID/FEI	Business Operations
Establishment
Estee Lauder Cosmetics Distribution Center		208579636	repack, relabel

Name	Address	ID/FEI	Business Operations
Establishment
Estee Lauder Kabushiki Kaisha		712808195	relabel, repack

Name	Address	ID/FEI	Business Operations
Establishment
Whitman Laboratories Ltd.		216866277	manufacture

Name	Address	ID/FEI	Business Operations
Establishment
Aveda Corporation		071352058	manufacture

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