SPL v2
SPL
SPL Set ID 2d490531-af38-87d0-e063-6394a90acf49
Route
TOPICAL
Published
Effective Date 2025-01-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (25 g)
Inactive Ingredients
Limonia Acidissima Bark Jojoba Oil Lecithin, Sunflower Babassu Oil Tallow Water Beeswax Leuconostoc/radish Root Ferment Filtrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-29
Description

Sunscreen

Medication Information

Warnings and Precautions

Warnings:

For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

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

Indications and Usage

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

Shake well before use.

Apply liberally 15 minutes before sun exposure.

Reapply:

after 80 minutes of swimming or sweating

immediately after towel drying

at least every 2 hours

Description

Sunscreen

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

Aqua (Water), Tallow, Simmondsia Chinensis (Jojoba) Seed Oil, Jojoba Esters, Lecithin, Cera Alba (Beeswax), Silica, Tocopherol (Vitamin E), Leuconostoc/Radish Root Ferment Filtrate

Section 51945-4

Section 55105-1

Sunscreen

Structured Label Content

Indications and Usage (34067-9)

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)

Shake well before use.

Apply liberally 15 minutes before sun exposure.

Reapply:

after 80 minutes of swimming or sweating

immediately after towel drying

at least every 2 hours

Warnings and Precautions (34071-1)

Warnings:

For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

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

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)

Aqua (Water), Tallow, Simmondsia Chinensis (Jojoba) Seed Oil, Jojoba Esters, Lecithin, Cera Alba (Beeswax), Silica, Tocopherol (Vitamin E), Leuconostoc/Radish Root Ferment Filtrate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:50.571448 · Updated: 2026-03-14T23:09:51.959406