ALMOST BRONZER- titanium dioxide powder

almost bronzer by

Drug Labeling and Warnings

almost bronzer by is a Otc medication manufactured, distributed, or labeled by clinique laboratories inc, ELGC Kabushiki Kaisha, Estee Lauder Pennsylvania Distribution Center 2 (PADC 2), ARAMIS, INC, ESTEE LAUDER COSMETICS DISTRIBUTION CENTER, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTEC KEYSTONE, NORTHTEC BRISTOL, NORTHTEC KEYSTONE, WHITMAN LABORATORIES, LTD., Aveda Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNING

Keep out of eyes.

Stop use if irritation occurs.

Keep out of reach of children.

ACTIVE INGREDIENT

TITANIUM DIOXIDE 9.80%

INGREDIENTS

TALC ZINC STEARATE ISOSTEARYL PALMITATE SILICA METHICONE TRIETHOXYCAPRYLYLSILANE LECITHIN TOCOPHERYL ACETATE GLYCERIN SODIUM HYALURONATE NYLON-12 ALUMINA TIN OXIDE TETRASODIUM EDTA SODIUM DEHYDROACETATE CHLORPHENESIN POTASSIUM SORBATE [+/- MICA IRON OXIDES (CI 77491 CI 77492 CI 77499) BISMUTH OXYCHLORIDE (CI 77163) TITANIUM DIOXIDE (CI 77891) RED 7 LAKE (CI 15850) YELLOW 5 LAKE (CI 19140) BLUE 1 LAKE (CI 42090) CARMINE (CI 75470)] [ILN34967]

SPL UNCLASSIFIED SECTION

© CLINIQUE LABORTORIES, DIST. NEW YORK, N.Y. 10022

PRINCIPAL DISPLAY PANEL - 9g Carton

C
CLINIQUE

almost bronzer
SPF 15
poudre bronzante
teint naturel

POIDS NET WT. .31 OZ./9 g e

INGREDIENTS AND APPEARANCE

ALMOST BRONZER   SPF 15
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-801
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
titanium dioxide (UNII: 15FIX9V2JP) (titanium dioxide - UNII:15FIX9V2JP)	titanium dioxide	9.8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
talc (UNII: 7SEV7J4R1U)
zinc stearate (UNII: H92E6QA4FV)
silicon dioxide (UNII: ETJ7Z6XBU4)
triethoxycaprylylsilane (UNII: LDC331P08E)
glycerin (UNII: PDC6A3C0OX)
hyaluronate sodium (UNII: YSE9PPT4TH)
stannic oxide (UNII: KM7N50LOS6)
edetate sodium (UNII: MP1J8420LU)
sodium dehydroacetate (UNII: 8W46YN971G)
chlorphenesin (UNII: I670DAL4SZ)
potassium sorbate (UNII: 1VPU26JZZ4)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)
bismuth oxychloride (UNII: 4ZR792I587)
cochineal (UNII: TZ8Z31B35M)
D&C red no. 7 (UNII: ECW0LZ41X8)
FD&C yellow no. 5 (UNII: I753WB2F1M)
FD&C blue no. 1 (UNII: H3R47K3TBD)
aluminum oxide (UNII: LMI26O6933)
lecithin, soybean (UNII: 1DI56QDM62)
mica (UNII: V8A1AW0880)
alpha-tocopherol acetate (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-801-01	1 in 1 CARTON
1		9 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/01/2001

Labeler - clinique laboratories inc (173047747)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC Kabushiki Kaisha		712808195	RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE, RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Business Operations
ARAMIS, INC		042918826	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 COSMETICS, LTD		253616536	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE

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
NORTEC KEYSTONE		787336577	MANUFACTURE, RELABEL, REPACK

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
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE

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