Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 08c9fc56-7d4f-ebc5-e063-6294a90a5317
Route
TOPICAL
Published
Effective Date 2023-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (15.6 g)
Inactive Ingredients
Isododecane Argan Oil Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Levomenol Squalane Polyglyceryl-3 Pentaricinoleate Tetrahexyldecyl Ascorbate Pistacia Lentiscus Resin Oil Propanediol Dicaprylate/caprate Apricot Kernel Oil Polyhydroxystearic Acid (2300 Mw) Triethoxycaprylylsilane Lecithin, Soybean Safflower Oil Aloe Vera Leaf .alpha.-tocopherol Acetate Ginger Camellia Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-28
Description

ACTIVE INGREDIENTS - ZINC OXIDE 15.6%

Medication Information

Warnings and Precautions

WARNINGS FOR EXTERNAL USE ONLY

Indications and Usage

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

Dosage and Administration

DIRECTIONS FOR SUNSCREEN USE: APPLY GENEROUSLY 15 MINUTES BEFORE SUN EXPOSURE. APPLY TO ALL SKIN EXPOSED BY THE SUN. CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR

SUN PROTECTION MEASURES: SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING. TO DECREASE THIS RISK, REGULARLY USE A SUNSCREEN WITH A BROAD SPECTRUM SPF VALUE OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING: LIMIT TIME IN SUN, ESPECIALLY FROM 10 A.M. - 2 P.M. WEAR LONG-SLEEVED SHIRTS, PANTS, HATS AND SUNGLASSES. REAPPLY AT LEAST EVERY 2 HOURS. USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING IMMEDIATELY AFTER TOWEL DRYING AT LEAST EVERY 2 HOURS.

Description

ACTIVE INGREDIENTS - ZINC OXIDE 15.6%

Section 50565-1

KEEP OUT OF THE REACH OF CHILDREN IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Section 50566-9

STOP USE AND ASK A DOCTOR IF SEVERE IRRITATION OCCURS

Section 50567-7

WHEN USING THIS PRODUCT KEEP OUT OF EYES. IF CONTACT OCCURS, RINSE WITH WATER.

Section 50570-1

DISCONTINUE USE IF IRRITATION OR REDNESS OCCURS

Section 51727-6

INACTIVE INGREDIENTS: ISODODECANE, SQUALANE, POLYSILICONE-11, PROPANEDIOL DICAPRYLATE/ CAPRATE, POLYHYDROXYSTEARIC ACID, POLYGLYCERYL-3 POLYRICINOLEATE, TRIETHOXYCAPRYLYLSILANE, TOCOPHERYL ACETATE, LECITHIN, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, TETRAHEXYLDECYL ASCORBATE, CAMELLIA OLEIFERA SEED OIL, PRUNUS ARMENIACA KERNEL OIL, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, ALOE BARBADENESIS LEAF EXTRACT, PISTACIA LENTISCUS (MASTIC) GUM OIL, ARGANIA SPINOSA KERNEL OIL, BISABOLOL

Section 51945-4

Section 55105-1

PURPOSE...............SUNSCREEN

Section 55106-9

ACTIVE INGREDIENTS - ZINC OXIDE 15.6%

Section 60561-8

OTHER INFORMATION:PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

DIRECTIONS FOR SUNSCREEN USE: APPLY GENEROUSLY 15 MINUTES BEFORE SUN EXPOSURE. APPLY TO ALL SKIN EXPOSED BY THE SUN. CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR

SUN PROTECTION MEASURES: SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING. TO DECREASE THIS RISK, REGULARLY USE A SUNSCREEN WITH A BROAD SPECTRUM SPF VALUE OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING: LIMIT TIME IN SUN, ESPECIALLY FROM 10 A.M. - 2 P.M. WEAR LONG-SLEEVED SHIRTS, PANTS, HATS AND SUNGLASSES. REAPPLY AT LEAST EVERY 2 HOURS. USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING IMMEDIATELY AFTER TOWEL DRYING AT LEAST EVERY 2 HOURS.

Warnings and Precautions (34071-1)

WARNINGS FOR EXTERNAL USE ONLY

Section 50565-1 (50565-1)

KEEP OUT OF THE REACH OF CHILDREN IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Section 50566-9 (50566-9)

STOP USE AND ASK A DOCTOR IF SEVERE IRRITATION OCCURS

Section 50567-7 (50567-7)

WHEN USING THIS PRODUCT KEEP OUT OF EYES. IF CONTACT OCCURS, RINSE WITH WATER.

Section 50570-1 (50570-1)

DISCONTINUE USE IF IRRITATION OR REDNESS OCCURS

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS: ISODODECANE, SQUALANE, POLYSILICONE-11, PROPANEDIOL DICAPRYLATE/ CAPRATE, POLYHYDROXYSTEARIC ACID, POLYGLYCERYL-3 POLYRICINOLEATE, TRIETHOXYCAPRYLYLSILANE, TOCOPHERYL ACETATE, LECITHIN, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, TETRAHEXYLDECYL ASCORBATE, CAMELLIA OLEIFERA SEED OIL, PRUNUS ARMENIACA KERNEL OIL, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, ALOE BARBADENESIS LEAF EXTRACT, PISTACIA LENTISCUS (MASTIC) GUM OIL, ARGANIA SPINOSA KERNEL OIL, BISABOLOL

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

PURPOSE...............SUNSCREEN

Section 55106-9 (55106-9)

ACTIVE INGREDIENTS - ZINC OXIDE 15.6%

Section 60561-8 (60561-8)

OTHER INFORMATION:PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:09.306231 · Updated: 2026-03-14T23:01:33.532889