drug facts

drug facts

SPL v1

SPL

SPL Set ID 531e3977-626e-4434-b337-9cdb9f998426

Route

topical

Published

Effective Date 2012-12-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

octisalate (5 g) titanium dioxide (23 g)

Inactive Ingredients

tridecyl stearate neopentyl glycol dicaprylate/dicaprate isostearyl neopentanoate tridecyl trimellitate carnauba wax ceresin ferric oxide red ferric oxide yellow ferrosoferric oxide ultramarine blue propylparaben butylparaben talc

Identifiers & Packaging

Marketing Status

otc monograph final active Since 2000-01-01

Description

Warnings : For external use only. Do not use on broken or damaged skin.

Medication Information

Active Ingredient

Active Ingredients: Octinoxate 7.5%, Octisalate 4.0%, Oxybenzone 4.0%

Purpose: Sunscreen

Description

Warnings : For external use only. Do not use on broken or damaged skin.

Section 43685-7

Warnings : For external use only. Do not use on broken or damaged skin.

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 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 51945-4

Structured Label Content

Active Ingredient (55106-9)

Active Ingredients: Octinoxate 7.5%, Octisalate 4.0%, Oxybenzone 4.0%

Purpose: Sunscreen

Section 43685-7 (43685-7)

Warnings : For external use only. Do not use on broken or damaged skin.

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 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 51945-4 (51945-4)

Advanced Ingredient Data

[{"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIM", "strengthNumerator": "5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "23", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "TRIDECYL STEARATE", "unii": "A8OE252M6L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE", "unii": "VLW429K27K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOSTEARYL NEOPENTANOATE", "unii": "411THY156Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIDECYL TRIMELLITATE", "unii": "FY36J270ES", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARNAUBA WAX", "unii": "R12CBM0EIZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CERESIN", "unii": "Q1LS2UJO3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE YELLOW", "unii": "EX438O2MRT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERROSOFERRIC OXIDE", "unii": "XM0M87F357", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ULTRAMARINE BLUE", "unii": "I39WR998BI", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYLPARABEN", "unii": "3QPI1U3FV8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"43685-7": "Warnings : For external use only. Do not use on broken or damaged skin.", "50565-1": "Keep out of reach of children . If product is swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if rash occurs", "50567-7": "When using this product keep out of eyes. Rinse with water to remove.", "55106-9": "Active Ingredients: Octinoxate 7.5%, Octisalate 4.0%, Oxybenzone 4.0% Purpose: Sunscreen"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:34.269550 · Updated: 2026-03-14T22:53:21.930902