Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 1548faf9-8623-f871-e063-6394a90a931f
Route
TOPICAL
Published
Effective Date 2024-04-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (20.28 g)
Inactive Ingredients
Dimethicone Castor Oil Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) C13-15 Alkane Polyglyceryl-6 Polyricinoleate Safflower Oil Hydrated Silica Coco-caprylate/caprate .alpha.-tocopherol Acetate Ferrosoferric Oxide Isododecane Kinetin Camellia Oil Apricot Kernel Oil Squalane Ferric Oxide Yellow Ferric Oxide Red Butyloctyl Salicylate Aloe Vera Leaf Lecithin, Soybean Propanediol Dicaprylate/caprate Disodium Stearoyl Glutamate Polyglyceryl-3 Pentaricinoleate Dilinoleic Acid/butanediol Copolymer Triethoxycaprylylsilane Polyhydroxystearic Acid (2300 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-04
Description

Active ingredients: Zinc Oxide 20.28%

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 •Apply generously and evenly15 minutes before sun exposure. • Reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours. • 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 time in the sun, especially from 10 a.m. -2 p.m., •wear long-sleeved shirts, pants, hats and sunglasses • Children under 6 months of age: Ask a doctor.

Description

Active ingredients: Zinc Oxide 20.28%

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, Polysilicone-11, C13-15 Alkane, Butyloctyl Salicylate, Propanediol Dicaprylate/Caprate, Dimethicone, Polyhydroxystearic Acid, Castor oil/IPDI Copolymer, Dilinoleic Acid/Butanediol Copolymer, Disodium Stearoyl Glutamate, Polyglyceryl-6 Polyricinoleate, Polyglyceryl-3 Polyricinoleate, Triethoxycaprylylsilane, Lecithin, Coco-Caprylate/Caprate, Camellia Oleifera (Seed) Oil, Kinetin, Prunus Armeniaca (Apricot) Kernel Oil, Squalane,Aloe Barbadensis Leaf Extract, Carthamus Tinctorius (Safflower) Seed Oil, Hydrated Silica, Tocopheryl Acetate, May Contain +/-, CI 77491 (Iron Oxide), CI 77492 (Iron Oxide), CI 77499 (Iron Oxide)

Section 51945-4

Section 55105-1

Purpose: Sunscreen

Section 55106-9

Active ingredients:

Zinc Oxide 20.28%

Section 60561-8

Other information • protect this product 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 •Apply generously and evenly15 minutes before sun exposure. • Reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours. • 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 time in the sun, especially from 10 a.m. -2 p.m., •wear long-sleeved shirts, pants, hats and sunglasses • Children under 6 months of age: Ask a doctor.

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, Polysilicone-11, C13-15 Alkane, Butyloctyl Salicylate, Propanediol Dicaprylate/Caprate, Dimethicone, Polyhydroxystearic Acid, Castor oil/IPDI Copolymer, Dilinoleic Acid/Butanediol Copolymer, Disodium Stearoyl Glutamate, Polyglyceryl-6 Polyricinoleate, Polyglyceryl-3 Polyricinoleate, Triethoxycaprylylsilane, Lecithin, Coco-Caprylate/Caprate, Camellia Oleifera (Seed) Oil, Kinetin, Prunus Armeniaca (Apricot) Kernel Oil, Squalane,Aloe Barbadensis Leaf Extract, Carthamus Tinctorius (Safflower) Seed Oil, Hydrated Silica, Tocopheryl Acetate, May Contain +/-, CI 77491 (Iron Oxide), CI 77492 (Iron Oxide), CI 77499 (Iron Oxide)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Sunscreen

Section 55106-9 (55106-9)

Active ingredients:

Zinc Oxide 20.28%

Section 60561-8 (60561-8)

Other information • protect this product from excessive heat and direct sun.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:55.776340 · Updated: 2026-03-14T23:02:45.179164