DailyMed - DailyMed Details

SPL v4

SPL

SPL Set ID 2de875d8-4211-3811-e063-6394a90a4f72

Route

TOPICAL

Published

Effective Date 2025-01-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (25 g)

Inactive Ingredients

Jojoba Oil Astaxanthin Beeswax Hydrolyzed Jojoba Esters Leuconostoc/radish Root Ferment Filtrate Tallow Tapioca Starch Lecithin, Sunflower Pinus Strobus Bark Aqua

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2026-02-01

Description

Sunscreen

Medication Information

Warnings and Precautions

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with

water to remove.

Stop use and ask a doctor if rash occurs.

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

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

Description

Sunscreen

Section 50565-1

Keep out of reach of children. If product is swallowed, get

medical help or contact a Poison Control Center right away.

Section 51727-6

Aqua (Water), Tallow,

Simmondsia Chinensis Seed

Oil (Jojoba 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)

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

Warnings and Precautions (34071-1)

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with

water to remove.

Stop use and ask a doctor if rash occurs.

Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get

medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Aqua (Water), Tallow,

Simmondsia Chinensis Seed

Oil (Jojoba 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

[{"name": "JOJOBA OIL", "unii": "724GKU717M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ASTAXANTHIN", "unii": "8XPW32PR7I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BEESWAX", "unii": "2ZA36H0S2V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROLYZED JOJOBA ESTERS", "unii": "UDR641JW8W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE", "unii": "D2QHA03458", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALLOW", "unii": "98HPY76U4W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TAPIOCA STARCH", "unii": "24SC3U704I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LECITHIN, SUNFLOWER", "unii": "834K0WOS5G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "PINUS STROBUS BARK", "unii": "8PJ4761097", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AQUA", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "34068-7": "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", "34071-1": "For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs.", "50565-1": "Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.", "51727-6": "Aqua (Water), Tallow, Simmondsia Chinensis Seed Oil (Jojoba Oil), Jojoba Esters, Lecithin, Cera Alba (Beeswax), Silica, Tocopherol (Vitamin E), Leuconostoc/Radish Root Ferment Filtrate", "55105-1": "Sunscreen"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:08:28.044589 · Updated: 2026-03-14T23:12:40.778283