5354c383-08f0-4b89-b36a-96a35f47be3c

SPL v3
SPL
SPL Set ID 5354c383-08f0-4b89-b36a-96a35f47be3c
Route
topical
Published
Effective Date 2024-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc cation (22.3 g)
Inactive Ingredients
water cocoyl caprylocaprate isoamyl laurate butyl salicylate glycerin propanediol jojoba oil shea butter polyglyceryl-6 stearate tridecyl salicylate polyglyceryl-6 behenate aloe vera leaf green tea leaf pongamia pinnata seed xanthan gum cetyl alcohol silicon dioxide soybean lecithin betasizofiran polyhydroxystearic acid stearate pullulan phenoxyethanol ethylhexylglycerin triethoxycaprylylsilane

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-09-26
Purpose

ZINC OXIDE 22.3%           SUNSCREEN

Description

ZINC OXIDE 22.3%           SUNSCREEN

Medication Information

Warnings
  • For external use only
  • Do not use ondamaged or broken skin. When using this product
  • Keep out of eyes. Rinse with water to remove. Stop use and ask doctor if 
  • rash or irritation develops and lasts. Keep out of reach of children
  • If product is swallowed, get medical help of contact a Poison Control Center right away.
Uses
  • HELPS PREVENT SUNBURN 
  • IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS ), DECREASES THE RISK OF SKIN CANCER AND EARLY AGING CAUSED BY THE SUN
Purpose

ZINC OXIDE 22.3%           SUNSCREEN

Directions
  • APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE REAPPLY: AFTER 80 MINUTES OF SWIMMING OR SWEATING 
  • IMMEDIATELY AFTER TOWEL DRYING 
  • AT LEAST EVERY 2 HOURS. 
  • SUN PROTECTION MEASURESSPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING. TO DECREASE THIS RISK, REGULARLY USE A SUNSCREEN WITH BROAD SPECTRUM SPF OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING 
  • LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 A.M.-2 P.M. 
  • WEAR LONG SLEEVE SHIRTS, PANTS, HATS, AND SUNGLASSES 
  • CHILDREN UNDER 6 MONTHS: ASK A DOCTOR
Other Information

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

Inactive Ingredients

WATER, COCO-CAPYLATE/CAPRATE (COCOYL CAPRYLOCAPRATE), ISOAMYL LAURATE, BUTYL SALICYLATE, GLYCERIN, PROPANEDIOL, BUTYROSPERMUM PARKII (SHEA BUTTER), SIMMONDSIA CHINENSIS (JOJOBA OIL),POLYGLYCERYL-6 STEARATE, TRIDECYL SALICYLATE, POLYGLYCERYL-6 BEHENATE, ALOE BARBADENSIS LEAF EXTRACT (ALOE VERA LEAF), CAMELLIA SINENSIS (GREEN TEA LEAF), SPHINGOMONAS FERMENT EXTRACT, PONGOMIA PINNATA SEED, Silica, XANTHAN GUM, CETYL ALCOHOL, LECITHIN, SCLEROTIUM GUM (BETASIZOFIRAN), POLYHYDROXYSTEARIC ACID, TRIETHOXYCAPRYLYLSILANE, PULLULAN, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN

Description

ZINC OXIDE 22.3%           SUNSCREEN

Product Label

Questions Or Comments?

Contact us : 1-800-721-2723

Active Ingredient             purpose

ZINC OXIDE 22.3%           SUNSCREEN

Structured Label Content

Warnings
  • For external use only
  • Do not use ondamaged or broken skin. When using this product
  • Keep out of eyes. Rinse with water to remove. Stop use and ask doctor if 
  • rash or irritation develops and lasts. Keep out of reach of children
  • If product is swallowed, get medical help of contact a Poison Control Center right away.
Uses
  • HELPS PREVENT SUNBURN 
  • IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS ), DECREASES THE RISK OF SKIN CANCER AND EARLY AGING CAUSED BY THE SUN
Directions
  • APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE REAPPLY: AFTER 80 MINUTES OF SWIMMING OR SWEATING 
  • IMMEDIATELY AFTER TOWEL DRYING 
  • AT LEAST EVERY 2 HOURS. 
  • SUN PROTECTION MEASURESSPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING. TO DECREASE THIS RISK, REGULARLY USE A SUNSCREEN WITH BROAD SPECTRUM SPF OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING 
  • LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 A.M.-2 P.M. 
  • WEAR LONG SLEEVE SHIRTS, PANTS, HATS, AND SUNGLASSES 
  • CHILDREN UNDER 6 MONTHS: ASK A DOCTOR
Other Information (Other information)

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

Inactive Ingredients

WATER, COCO-CAPYLATE/CAPRATE (COCOYL CAPRYLOCAPRATE), ISOAMYL LAURATE, BUTYL SALICYLATE, GLYCERIN, PROPANEDIOL, BUTYROSPERMUM PARKII (SHEA BUTTER), SIMMONDSIA CHINENSIS (JOJOBA OIL),POLYGLYCERYL-6 STEARATE, TRIDECYL SALICYLATE, POLYGLYCERYL-6 BEHENATE, ALOE BARBADENSIS LEAF EXTRACT (ALOE VERA LEAF), CAMELLIA SINENSIS (GREEN TEA LEAF), SPHINGOMONAS FERMENT EXTRACT, PONGOMIA PINNATA SEED, Silica, XANTHAN GUM, CETYL ALCOHOL, LECITHIN, SCLEROTIUM GUM (BETASIZOFIRAN), POLYHYDROXYSTEARIC ACID, TRIETHOXYCAPRYLYLSILANE, PULLULAN, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN

Product Label (Product label)

Questions Or Comments? (Questions or comments?)

Contact us : 1-800-721-2723

Active Ingredient             purpose (Active Ingredient             Purpose)

ZINC OXIDE 22.3%           SUNSCREEN

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:39.395212 · Updated: 2026-03-14T23:13:35.542610