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SUNTINTS

MAKEUP ART COSMETICS




FULL PRESCRIBING INFORMATION

Active ingredient

ACTIVE INGREDIENTS: OCTINOXATE 7.50% [] OCTISALATE 5.00% [] AVOBENZONE 3.00% [] HOMOSALATE 2.90% [] OCTOCRYLENE 2.70%

INACTIVE INGREDIENTS: OCTYLDODECANOL [] NEOPENTYL GLYCOL DIHEPTANOATE [] ETHYLCELLULOSE [] DIISOSTEARYL MALATE [] BUTYLOCTYL SALICYLATE [] DICAPRYLYL CARBONATE [] TOCOPHERYL ACETATE [] POLYGONUM CUSPIDATUM ROOT EXTRACT [] DEXTRIN PALMITATE [] CALCIUM ALUMINUM BOROSILICATE [] CALCIUM SODIUM BOROSILICATE [] CAPRYLYL GLYCOL [] HEXYLENE GLYCOL [] SILICA [] TIN OXIDE [] LINOLEIC ACID [] HYDROGENATED DILINOLEYL ALCOHOL [] VANILLIN [] PHENOXYETHANOL []  [+/- MICA [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] TITANIUM DIOXIDE (CI 77891) [] BISMUTH OXYCHLORIDE (CI 77163) [] BLUE 1 LAKE (CI 42090) [] CARMINE (CI 75470) [] RED 6 (CI 15850) [] RED 7 LAKE (CI 15850) [] RED 28 LAKE (CI 45410) [] RED 30 LAKE (CI 73360) [] RED 33 LAKE (CI 17200) [] YELLOW 5 LAKE (CI 19140) [] YELLOW 6 LAKE (CI 15985)]

WARNING: STOP USE IF IRRITATION OCCURS.

MAC

SUNTINTS SPF 20

LIQUID BALM




10 ML/ .33 FL OZ LIQ





MAKE UP ART COSMETICS, DIST

NY,NY 10022

SUNTINTS

SUNTINTS

OCTINOXATE, OCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:40046-0034
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 7.5 mL
OCTISALATE OCTISALATE 5.0 mL
AVOBENZONE AVOBENZONE 3.0 mL
HOMOSALATE Homosalate 2.9 mL
OCTOCRYLENE Octocrylene 2.7 mL

Inactive Ingredients

Ingredient Name Strength
OCTYLDODECANOL
NEOPENTYL GLYCOL DIHEPTANOATE
ETHYLCELLULOSES
Diisostearyl Malate
BUTYLOCTYL SALICYLATE
DICAPRYLYL CARBONATE
ALPHA-TOCOPHEROL ACETATE
POLYGONUM CUSPIDATUM ROOT
CALCIUM ALUMINOSILICATE
CAPRYLYL GLYCOL
Hexylene Glycol
SILICON DIOXIDE
STANNIC OXIDE
LINOLEIC ACID
VANILLIN
PHENOXYETHANOL
ferric oxide red
MICA
titanium dioxide
FD&C BLUE NO. 1
COCHINEAL
D&C RED NO. 6
D&C RED NO. 7
D&C RED NO. 28
D&C RED NO. 30
D&C RED NO. 33
FD&C YELLOW NO. 5

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:40046-0034-2 10 in 1 VIAL
2 NDC:40046-0034-1 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2009-12-01


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