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CAMERA READY

SMASHBOX BEAUTY COSMETICS, INC




FULL PRESCRIBING INFORMATION

Active ingredient

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


 

CAMERA READY

OCTINOXlATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10348-002
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 7.5 mL
OCTISALATE OCTISALATE 4.0 mL
OXYBENZONE OXYBENZONE 2.5 mL
titanium dioxide 1.1 mL

Inactive Ingredients

Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:10348-002-02 30 in 1 TUBE
2 NDC:10348-002-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2011-05-01


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