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
Purpose

SUNSCREEN

Description

ZINC OXIDE 12%

Medication Information

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
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.

Purpose

SUNSCREEN

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

Other Information

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

Description

ZINC OXIDE 12%

Questions?

1-866-325-7546

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

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

Active Ingredient

ZINC OXIDE 12%

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

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
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.

Purpose (PURPOSE)

SUNSCREEN

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

Other Information (OTHER INFORMATION)

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

Questions? (QUESTIONS?)

1-866-325-7546

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

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)

Active Ingredient (ACTIVE INGREDIENT)

ZINC OXIDE 12%

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:15.419254 · Updated: 2026-03-14T23:06:47.753582