NUDE AND IMPROVED BARE FACE MAKEUP SPF 15- titanium dioxide lotion

NUDE AND IMPROVED BARE FACE MAKEUP by

Drug Labeling and Warnings

NUDE AND IMPROVED BARE FACE MAKEUP by is a Otc medication manufactured, distributed, or labeled by ORIGINS NATURAL RESOURCES INC., ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER N.V., Len-Ron Manufacturing Division of Aramis Inc., Aramis Inc., Northtec Bristol, Northtec Keystone, Estee Lauder Pennsylvania Distribution Center 2, Estee Lauder Cosmetics, Ltd., Estee Lauder Cosmetics, Ltd, Estee Lauder Cosmetics Distribution Center, Estee Lauder Kabushiki Kaisha, Whitman Laboratories Ltd., Aveda Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59427-761-02	1 in 1 CARTON
1	NDC: 59427-761-01	30 mL in 1 BOTTLE

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

Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)

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

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

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

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

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

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

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

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

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

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

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

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

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