ALMOST BRONZER  SPF 15- titanium dioxide powder 
clinique laboratories 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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CLINIQUE
almost bronzer
SPF 15

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]

© 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

Principal Display Panel - 9 g Carton
ALMOST BRONZER   SPF 15
titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-801
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
titanium dioxide (UNII: 15FIX9V2JP) (titanium dioxide - UNII:15FIX9V2JP) titanium dioxide9.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49527-801-011 in 1 CARTON
19 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/2001
Labeler - clinique laboratories inc (173047747)
Establishment
NameAddressID/FEIBusiness Operations
ELGC Kabushiki Kaisha712808195RELABEL, REPACK
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE, RELABEL, REPACK
Establishment
NameAddressID/FEIBusiness Operations
ARAMIS, INC042918826MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK, RELABEL
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
NORTEC KEYSTONE787336577MANUFACTURE, RELABEL, REPACK
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC BRISTOL949264774MANUFACTURE, RELABEL, REPACK
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC KEYSTONE618107429MANUFACTURE, RELABEL, REPACK
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058MANUFACTURE

Revised: 8/2011
Document Id: ac87746b-ecb8-4446-a496-6f00d91cf549
Set id: 1b945dfb-d568-4325-9589-cdfe78c02958
Version: 1
Effective Time: 20110818
 
clinique laboratories inc