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SPL v2

SPL

SPL Set ID 47dbcf07-7e3a-e3de-e063-6294a90a2c21

Route

TOPICAL

Published

Effective Date 2026-02-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (8.93 g)

Inactive Ingredients

Simmondsia Chinensis (jojoba) Seed Oil Beeswax Pinus Strobus Bark Astaxanthin Aqua Tallow Hydrolyzed Jojoba Esters Leuconostoc/radish Root Ferment Filtrate Lecithin, Sunflower Tapioca Starch

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.

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 befoe use.

Apply literally 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 childen. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

AQUA

TALLOW

ZINC OXIDE

JOJOBA OIL

HYDROLYZED JOJOBA ESTERS

LECITHIN, SUNFLOWER

BEESWAX

LIMONIA ACIDISSIMA BARK

BABASSU OIL

ASTAXANTHIN

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 befoe use.

Apply literally 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)

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 childen. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

AQUA

TALLOW

ZINC OXIDE

JOJOBA OIL

HYDROLYZED JOJOBA ESTERS

LECITHIN, SUNFLOWER

BEESWAX

LIMONIA ACIDISSIMA BARK

BABASSU OIL

ASTAXANTHIN

LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Advanced Ingredient Data

[{"name": "SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL", "unii": "724GKU717M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BEESWAX", "unii": "2ZA36H0S2V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PINUS STROBUS BARK", "unii": "8PJ4761097", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ASTAXANTHIN", "unii": "8XPW32PR7I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AQUA", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALLOW", "unii": "98HPY76U4W", "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": "LECITHIN, SUNFLOWER", "unii": "834K0WOS5G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TAPIOCA STARCH", "unii": "24SC3U704I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "8.93", "strengthDenominator": "85", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

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": "Shake well befoe use. Apply literally 15 minutes before sun exposure. Reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours", "34071-1": "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.", "50565-1": "Keep out of reach of childen. If swallowed, get medical help or contact a Poison Control Center right away.", "51727-6": "AQUA TALLOW ZINC OXIDE JOJOBA OIL HYDROLYZED JOJOBA ESTERS LECITHIN, SUNFLOWER BEESWAX LIMONIA ACIDISSIMA BARK BABASSU OIL ASTAXANTHIN LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE", "55105-1": "Sunscreen"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:28.104127 · Updated: 2026-03-14T23:12:40.778283