almost bronzer spf 15

Dosage form: powder
Ingredients: titanium dioxide 9.8g in 100g
Labeler: clinique laboratories inc
NDC Code: 49527-801

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.

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

ALMOST BRONZER   SPF 15
titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-801
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
titanium dioxide (titanium dioxide) titanium dioxide9.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
talc 
zinc stearate 
silicon dioxide 
triethoxycaprylylsilane 
glycerin 
hyaluronate sodium 
stannic oxide 
edetate sodium 
sodium dehydroacetate 
chlorphenesin 
potassium sorbate 
ferric oxide red 
ferric oxide yellow 
ferrosoferric oxide 
bismuth oxychloride 
cochineal 
D&C red no. 7 
FD&C yellow no. 5 
FD&C blue no. 1 
aluminum oxide 
lecithin, soybean 
mica 
alpha-tocopherol acetate 
Packaging
#Item CodePackage Description
1NDC:49527-801-011 CONTAINER (CONTAINER) 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/FEIOperations
ELGC Kabushiki Kaisha712808195RELABEL, REPACK
Establishment
NameAddressID/FEIOperations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE, RELABEL, REPACK
Establishment
NameAddressID/FEIOperations
ARAMIS, INC042918826MANUFACTURE
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK, RELABEL
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER N.V.370151326MANUFACTURE
Establishment
NameAddressID/FEIOperations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE
Establishment
NameAddressID/FEIOperations
NORTEC KEYSTONE787336577MANUFACTURE, RELABEL, REPACK
Establishment
NameAddressID/FEIOperations
NORTHTEC BRISTOL949264774MANUFACTURE, RELABEL, REPACK
Establishment
NameAddressID/FEIOperations
NORTHTEC KEYSTONE618107429MANUFACTURE, RELABEL, REPACK
Establishment
NameAddressID/FEIOperations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE
Establishment
NameAddressID/FEIOperations
Aveda Corporation071352058MANUFACTURE

Revised: 08/2011
 
clinique laboratories inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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