Skin Authority - Skinsuit Face Spf-50 (46007-204)

Skin Authority - Skinsuit Face Spf-50 (46007-204)
SPL v6
SPL
SPL Set ID 389fc528-fda5-485a-ab37-f99fcf3ed0b3
Route
TOPICAL
Published
Effective Date 2020-01-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (12 g)
Inactive Ingredients
Water Alkyl (c12-15) Benzoate Butyloctyl Salicylate Isododecane Peg-8 Dimethicone Polymethylsilsesquioxane (11 Microns) Octyldodecyl Neopentanoate Propanediol Dimethicone Caprylyl Trisiloxane Niacinamide Dimethiconol/propylsilsesquioxane/silicate Crosspolymer (450000000 Mw) Trilaureth-4 Phosphate Allantoin .alpha.-bisabolol, (+)- Caprylyl Glycol Ethylhexylglycerin Hexylene Glycol Ferric Oxide Red Peg-10 Dimethicone (600 Cst) Polyethylene Glycol 500 Phenoxyethanol Sodium Chloride Sodium Hydroxide Tetrasodium Glutamate Diacetate Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-04-19

Description

ZINC OXIDE 12%

Purpose

SUNSCREEN


Medication Information

Purpose

SUNSCREEN

Description

ZINC OXIDE 12%

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.

Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

  • IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
Section 51727-6

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.

Section 51945-4

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
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

Questions?

1-866-325-7546

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

Active Ingredient

ZINC OXIDE 12%

Other Information

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

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


Structured Label Content

Uses (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.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

  • IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
Section 51727-6 (51727-6)

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.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

SUNSCREEN

Warnings (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
Directions (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

Questions? (QUESTIONS?)

1-866-325-7546

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

Active Ingredient (ACTIVE INGREDIENT)

ZINC OXIDE 12%

Other Information (OTHER INFORMATION)

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

Sun Protection Measures: (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


Advanced Ingredient Data


Raw Label Data

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