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CAMERA READY 5 IN 1 BEAUTY BALM SPF 35

Dosage form: liquid
Ingredients: OCTINOXATE 7.5mL in 100mL, OCTISALATE 4.0mL in 100mL, OXYBENZONE 2.5mL in 100mL, TITANIUM DIOXIDE 1.1mL in 100mL
Labeler: SMASHBOX BEAUTY COSMETICS, INC
NDC Code: 10348-002

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.

ACTIVE INGREDIENTS: OCTINOXATE 7.50% [] OCTISALATE 4.00% [] OXYBENZONE 2.50% [] TITANIUM DIOXIDE 1.10%

INACTIVE INGREDIENTS: WATER [] DIMETHICONE [] BUTYLENE GLYCOL [] PHENYL TRIMETHICONE [] PENTYLENE GLYCOL [] GLYCERYL STEARATE [] BEHENYL ALCOHOL [] TRIOCTYLDODECYL CITRATE [] POLYMETHYLSILSESQUIOXANE [] OCTYLDODECYL STEAROYL STEARATE [] PEG-40 STEARATE [] POLYGLYCERYL-10 PENTASTEARATE [] AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER [] TRITICUM VULGARE (WHEAT) GERM EXTRACT [] HORDEUM VULGARE (BARLEY) EXTRACT [] CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT [] LAMINARIA SACCHARINA EXTRACT [] PYRUS MALUS (APPLE) FRUIT EXTRACT [] SCUTELLARIA BAICALENSIS ROOT EXTRACT [] POLYQUATERNIUM-51 [] ACETYL HEXAPEPTIDE-8 [] TREHALOSE [] ORYZANOL [] OCTYLDODECYL NEOPENTANOATE [] UREA [] POLYGLYCERYL-6 POLYRICINOLEATE [] PROPYLENE GLYCOL LAURATE [] GLYCYRRHETINIC ACID [] TOCOPHERYL ACETATE [] SUCROSE [] GLYCERIN [] SODIUM STEAROYL LACTYLATE [] CAFFEINE [] LINOLEIC ACID [] CHOLESTEROL [] LECITHIN [] SQUALANE [] SODIUM PCA [] ISOPROPYL TITANIUM TRIISOSTEARATE [] PROPYLENE GLYCOL STEARATE [] STEARIC ACID [] POLYSORBATE 20 [] SORBITAN LAURATE [] XANTHAN GUM [] ALUMINUM HYDROXIDE [] SODIUM HYALURONATE [] SILICA [] DISODIUM EDTA [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] SODIUM DEHYDROACETATE [] CHLORPHENESIN [] PHENOXYETHANOL []  [+/- TITANIUM DIOXIDE (CI 77891) [] ZINC OXIDE (CI 77947) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] MICA

WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS.

KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL:

SMASHBOX CAMERA READY

5 IN 1

BEAUTY BALM

SPF 35


1.0 FL OZ/ 30 ML




Smashbox Beauty Cosmetics Inc.

Culver City, California, 90232

made in canada

 


 

CAMERA READY  5 IN 1 BEAUTY BALM SPF 35
octinoxlate, octisalate, oxybenzone, titanium dioxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10348-002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 mL  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE4.0 mL  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE2.5 mL  in 100 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE1.1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
DIMETHICONE 
BUTYLENE GLYCOL 
PHENYL TRIMETHICONE 
PENTYLENE GLYCOL 
GLYCERYL MONOSTEARATE 
DOCOSANOL 
POLYMETHYLSILSESQUIOXANE (11 MICRONS) 
OCTYLDODECYL STEAROYL STEARATE 
PEG-40 STEARATE 
WHEAT GERM 
CUCUMBER 
APPLE 
SCUTELLARIA BAICALENSIS ROOT 
ACETYL HEXAPEPTIDE-3 
TREHALOSE 
GAMMA ORYZANOL 
OCTYLDODECYL NEOPENTANOATE 
UREA 
PROPYLENE GLYCOL MONOLAURATE 
ALPHA-TOCOPHEROL ACETATE 
SUCROSE 
GLYCERIN 
CAFFEINE 
LINOLEIC ACID 
CHOLESTEROL 
LECITHIN, SOYBEAN 
SQUALANE 
SODIUM PYRROLIDONE CARBOXYLATE 
PROPYLENE GLYCOL MONOSTEARATE 
STEARIC ACID 
POLYSORBATE 20 
SORBITAN MONOLAURATE 
XANTHAN GUM 
ALUMINUM HYDROXIDE 
HYALURONATE SODIUM 
SILICON DIOXIDE 
SODIUM DEHYDROACETATE 
CHLORPHENESIN 
PHENOXYETHANOL 
MICA 
FERRIC OXIDE RED 
Packaging
#Item CodePackage Description
1NDC:10348-002-011 TUBE (TUBE) in 1 CARTON
1NDC:10348-002-0230 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/01/2011
Labeler - SMASHBOX BEAUTY COSMETICS, INC (945344414)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD205952385manufacture
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER N.V.370151326manufacture
Establishment
NameAddressID/FEIOperations
Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
Establishment
NameAddressID/FEIOperations
Aramis Inc.042918826manufacture
Establishment
NameAddressID/FEIOperations
Northtec Bristol949264774manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Northtec Keystone618107429manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics, Ltd.255175580manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics, Ltd253616536manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics Distribution Center208579636repack, relabel
Establishment
NameAddressID/FEIOperations
Estee Lauder Kabushiki Kaisha712808195relabel, repack
Establishment
NameAddressID/FEIOperations
Whitman Laboratories Ltd.216866277manufacture
Establishment
NameAddressID/FEIOperations
Aveda Corporation071352058manufacture

Revised: 07/2011
Document Id: 94e364ba-9e7c-41f8-864d-dd3d70b2f24b
Set id: 1137a998-539c-4271-b092-990e9ef6f2e7
Version: 2
Effective Time: 20110701
 
SMASHBOX BEAUTY COSMETICS, 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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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