SKINSUIT FACE SPF 50- zinc oxide lotion

SKINSUIT FACE by

Drug Labeling and Warnings

SKINSUIT FACE by is a Otc medication manufactured, distributed, or labeled by Skin Authority LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ZINC OXIDE 12%

PURPOSE

SUNSCREEN

USES

• HELPS PREVENT SUNBURN
• IF USED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS), DECREASES THE RISK OF SKIN CANCER AND EARLY SKIN AGING CAUSED BY SUN.

WARNINGS

FOR EXTERNAL USE ONLY.

DO NOT USE ON

• BROKEN SKIN
• SERIOUS BURNS

WHEN USING THIS PRODUCT

• KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

STOP USE AND ASK A DOCTOR IF

• RASH OR IRRITATION DEVELOPS AND LASTS

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

• IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

SUN PROTECTION MEASURES:

SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING. TO DECREASE RISK, REGULARLY USE A SUNSCREEN WITH BROAD SPECTRUM SPF VALUE OF 15+ AND OTHER SUN PROTECTION MEASURES

• LIMIT TIME IN THE SUN FROM 10AM - 2PM
• WEAR LONG SLEEVED SHIRT, PANTS, HATS, AND SUNGLASSES

DIRECTIONS

APPLY EVENLY TO FACE 15 MINUTES BEFORE EXPOSURE.

• REAPPLY EVERY 2 HOURS
• REAPPLY AS NEEDED AFTER SWIMMING OR PERSPIRING
• CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR

INACTIVE INGREDIENT

WATER, C12-15 ALKYL BENZOATE, BUTYLOCTYL SALICYLATE, ISODODECANSE, LAURYL PEG-8 DIMETHICONE, POLYMETHYLSILSESQUIOXANE, OCTYLDODECYL NEOPENTANOATE, PROPANEDIOL, DIMETHICONE, CAPRYLYL METHICONE, NIACINAMIDE, DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER, TRILAURETH-4 PHOSPHATE, ALLANTOIN, BISABOLOL, CAPRYL GLYCOL, ETHYHEXYLGLYCERIN, HEXYLENE GLYCOL, IRON OXIDES, LAURYL PEG-10 TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE, PEG-10, PHENOXYETHANOL, SODIUM CHLORIDE, SODIUM HYDROXIDE, TETRASODIUM GLUTAMATE DIACETATE, TOCOPHEROL.

OTHER INFORMATION

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN. STORE AT 40° - 95°F (5° - 35°C).

QUESTIONS?

1-866-325-7546

MONDAY - FRIDAY (9 A.M. TO 5 P.M. PST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SKINSUIT FACE  SPF 50
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46007-204
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	12 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ISODODECANE (UNII: A8289P68Y2)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PROPANEDIOL (UNII: 5965N8W85T)
DIMETHICONE (UNII: 92RU3N3Y1O)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
NIACINAMIDE (UNII: 25X51I8RD4)
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)
ALLANTOIN (UNII: 344S277G0Z)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46007-204-11	50 mL in 1 TUBE; Type 0: Not a Combination Product	01/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/19/2012

Labeler - Skin Authority LLC (136549396)

Registrant - Skin Authority LLC (136549396)