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PREP AND PRIME

MAKEUP ART COSMETICS




FULL PRESCRIBING INFORMATION

Active ingredient

ACTIVE INGREDIENTS: OCTINOXATE 7.40% [] OCTISALATE 4.00% [] ZINC OXIDE 3.50% [] OXYBENZONE 2.50% [] TITANIUM DIOXIDE 1.10%

INACTIVE INGREDIENTS: WATER\AQUA\EAU [] DIMETHICONE [] BUTYLENE GLYCOL [] PHENYL TRIMETHICONE [] PENTYLENE GLYCOL [] GLYCERYL STEARATE [] BEHENYL ALCOHOL [] TRIOCTYLDODECYL CITRATE [] POLYMETHYLSILSESQUIOXANE [] OCTYLDODECYL STEAROYL STEARATE [] PEG-40 STEARATE [] POLYGLYCERYL-10 PENTASTEARATE [] OCTYLDODECYL NEOPENTANOATE [] TOCOPHERYL ACETATE [] CAFFEINE [] GLYCYRRHETINIC ACID [] UREA [] SODIUM HYALURONATE [] SQUALANE [] HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE [] TRITICUM VULGARE (WHEAT) GERM EXTRACT [] LAMINARIA SACCHARINA EXTRACT [] GLYCERIN [] LECITHIN [] POLYGLYCERYL-6 POLYRICINOLEATE [] CHOLESTEROL [] TREHALOSE [] SODIUM PCA [] ORYZANOL [] AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER [] SUCROSE [] SODIUM STEAROYL LACTYLATE [] XANTHAN GUM [] POLYQUATERNIUM-51 [] ISOPROPYL TITANIUM TRIISOSTEARATE [] TRIETHOXYCAPRYLYLSILANE [] SILICA [] ALUMINA [] LINOLEIC ACID [] STEARIC ACID [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] DISODIUM EDTA [] PHENOXYETHANOL [] CHLORPHENESIN [] SODIUM DEHYDROACETATE []  [+/- MICA [] TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] BISMUTH OXYCHLORIDE (CI 77163) [] BLUE 1 LAKE (CI 42090) [] CARMINE (CI 75470) [] CHROMIUM HYDROXIDE GREEN (CI 77289) [] FERRIC FERROCYANIDE (CI 77510) [] YELLOW 5 LAKE (CI 19140)]

DIRECTIONS: SMOOTH EVENLY ALL OVER THE FACE OR TO THE DESIRED AREAS AFTER MOISTURIZER WITH FINGERTIPS, SPONGE OR BRUSH.

WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. IF IRRITATION PERSISTS, DISCONTINUE USE AND CONTACT A HEALTH CARE PRACTITIONER.

KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL:

PREP + PRIME

FORTIFIED SKIN ENHANCER

SPF 35


NT WT 1.0 FL OZ/ 30 ML



DISTR BY MAKE UP ART COSMETICS

TORONTO, ONTARIO, CANADA M5V 1R7

PREP AND PRIME




PREP AND PRIME

OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:40046-0039
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 7.4 mL
OCTISALATE OCTISALATE 4.0 mL
Zinc Oxide Zinc oxide 3.5 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
OCTYLDODECYL NEOPENTANOATE
ALPHA-TOCOPHEROL ACETATE
CAFFEINE
ENOXOLONE
UREA
HYALURONATE SODIUM
SQUALANE
BARLEY
WHEAT GERM
GLYCERIN
LECITHIN, SOYBEAN
CHOLESTEROL
TREHALOSE
SODIUM PYRROLIDONE CARBOXYLATE
GAMMA ORYZANOL
SUCROSE
SODIUM STEAROYL LACTYLATE
XANTHAN GUM
TRIETHOXYCAPRYLYLSILANE
SILICON DIOXIDE
ALUMINUM OXIDE
LINOLEIC ACID
STEARIC ACID
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)
EDETATE DISODIUM
PHENOXYETHANOL
CHLORPHENESIN
SODIUM DEHYDROACETATE
MICA
ferric oxide red
FD&C YELLOW NO. 5

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:40046-0039-2 30 in 1 TUBE
2 NDC:40046-0039-1 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2011-04-01


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