SKINSUIT LIP SPF 30- zinc oxide gel

SKINSUIT LIP by

Drug Labeling and Warnings

SKINSUIT LIP 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 10%

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 UPPER AND LOWER LIP 15 MINUTES BEFORE EXPOSURE. NATURAL TINT WILL ABSORB AND BECOME SHEER.

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

INACTIVE INGREDIENT

HYDROGENATED POLY(C6-14 OLEFIN), SQUALANE, BUTYLOCTYL SALICYLATE, CETEARYL DIMETHICONE, ISODODECANE, ETHYLENE/PROPYLENE/STYRENE COPOLYMER, CAPRYLYL METHICONE, SYNTHETIC FLUORPHLOGOPITE, IRON OXIDE, LECITHIN, BUTYLENE/ETHYLENE/STYRENE COPOLYMER, CAPRYLYL GLYCOL, DIMETHICONE, DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, PHENYLPROPANOL, PROPANEDIOL, TIN OXIDE, TITANIUM DIOXIDE (CI 77891), 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 LIP  SPF 30
zinc oxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46007-205
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED POLY(C6-14 OLEFIN; 2 CST) (UNII: P0TX083987)
SQUALANE (UNII: GW89575KF9)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CETEARYL METHICONE (15000 MW) (UNII: VY9RTR7MSY)
ISODODECANE (UNII: A8289P68Y2)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
PHENYLPROPANOL (UNII: 0F897O3O4M)
PROPANEDIOL (UNII: 5965N8W85T)
STANNIC OXIDE (UNII: KM7N50LOS6)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46007-205-11	3.2 g in 1 BOTTLE, WITH APPLICATOR; 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	01/02/2020

Labeler - Skin Authority LLC (136549396)

Registrant - Skin Authority LLC (136549396)