Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID f1761b09-9061-a052-e053-2a95a90a39c8
Route
TOPICAL
Published
Effective Date 2023-01-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (15.6 g)
Inactive Ingredients
Isododecane Hydrogenated Rapeseed Oil Limonene, (+)- Camellia Oil Safflower Oil Coco-caprylate/caprate Lecithin, Soybean Medium-chain Triglycerides Polyglyceryl-6 Polyricinoleate Water Propanediol Dicaprylate/caprate Polyglyceryl-3 Pentaricinoleate Citric Acid Monohydrate Ferrosoferric Oxide Aloe Vera Leaf Citral Orange Oil Apricot Kernel Oil Squalane Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Polyhydroxystearic Acid (2300 Mw) Triethoxycaprylylsilane .alpha.-tocopherol Acetate Ferric Oxide Red Disodium Stearoyl Glutamate Castor Oil Linalool, (+/-)- Hydrated Silica Ginger Ferric Oxide Yellow Hydrogenated Palm Oil Tetrahexyldecyl Ascorbate Dilinoleic Acid/butanediol Copolymer Sodium Sulfate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-04
Description

Active ingredient 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 • shake well before use • apply generously 15 minutes before sun exposure • children under 6 months of age: Ask a doctor • reapply at least every 2 hours • use a water resistant sunscreen if swimming or sweating • 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 the sun, especially from 10 a.m.-2 p.m. • wear long-sleeved shirts, pants, hats and sunglasses

Description

Active ingredient Zinc Oxide 15.6%

Section 50565-1

Keep out of 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 rash occurs

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove

Section 50570-1

Do not use on damaged or broken skin

Section 51727-6

Inactive ingredients

ISODODECANE, SQUALANE, POLYSILICONE-11, PROPANEDIOL DICAPRYLATE/CAPRATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, POLYHYDROXYSTEARIC ACID, POLYGLYCERYL-3 POLYRICINOLEATE, TRIETHOXYCAPRYLYLSILANE, LECITHIN, IRON OXIDES (CI 77492), HYDROGENATED PALM OIL, HYDROGENATED RAPESEED OIL, COCO-CAPRYLATE/CAPRATE, HYDRATED SILICA, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, LIMONENE, CAMELLIA OLEIFERA SEED OIL, TETRAHEXYLDECYL ASCORBATE, TOCOPHERYL ACETATE, POLYGLYCERYL-6 POLYRICINOLEATE, IRON OXIDES (CI 77491), DILINOLEIC ACID/BUTANEDIOL COPOLYMER, DISODIUM STEAROYL GLUTAMATE, AQUA/WATER/EAU, PRUNUS ARMENIACA (APRICOT) KERNEL OIL, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, CASTOR OIL/IPDI COPOLYMER, IRON OXIDES (CI 77499), SODIUM SULFATE, ALOE BARBADENSIS LEAF EXTRACT, CITRAL, LINALOOL, CITRIC ACID.

Section 51945-4

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Active ingredient

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 • shake well before use • apply generously 15 minutes before sun exposure • children under 6 months of age: Ask a doctor • reapply at least every 2 hours • use a water resistant sunscreen if swimming or sweating • 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 the sun, especially from 10 a.m.-2 p.m. • wear long-sleeved shirts, pants, hats and sunglasses

Warnings and Precautions (34071-1)

Warnings

For external use only

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 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 51727-6 (51727-6)

Inactive ingredients

ISODODECANE, SQUALANE, POLYSILICONE-11, PROPANEDIOL DICAPRYLATE/CAPRATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, POLYHYDROXYSTEARIC ACID, POLYGLYCERYL-3 POLYRICINOLEATE, TRIETHOXYCAPRYLYLSILANE, LECITHIN, IRON OXIDES (CI 77492), HYDROGENATED PALM OIL, HYDROGENATED RAPESEED OIL, COCO-CAPRYLATE/CAPRATE, HYDRATED SILICA, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, LIMONENE, CAMELLIA OLEIFERA SEED OIL, TETRAHEXYLDECYL ASCORBATE, TOCOPHERYL ACETATE, POLYGLYCERYL-6 POLYRICINOLEATE, IRON OXIDES (CI 77491), DILINOLEIC ACID/BUTANEDIOL COPOLYMER, DISODIUM STEAROYL GLUTAMATE, AQUA/WATER/EAU, PRUNUS ARMENIACA (APRICOT) KERNEL OIL, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, CASTOR OIL/IPDI COPOLYMER, IRON OXIDES (CI 77499), SODIUM SULFATE, ALOE BARBADENSIS LEAF EXTRACT, CITRAL, LINALOOL, CITRIC ACID.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 55106-9 (55106-9)

Active ingredient

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: 2026-02-15T12:04:41.331921 · Updated: 2026-03-14T23:05:37.016425