bd64eb4d-4318-9d87-e053-2a95a90a7503

SPL v1

SPL

SPL Set ID bd64eb4d-4318-9d87-e053-2a95a90a7503

Route

topical

Published

Effective Date 2021-03-13

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

titanium dioxide (4.5 g) octinoxate (5 g) octisalate (4 g)

Inactive Ingredients

water

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2021-03-13

Purpose

helps prevent sunburn

Description

ethylhexyl methoxycinnamate, titanium dioxide, ethylhexyl salicylate

Medication Information

Uses

for external use only

Purpose

helps prevent sunburn

Description

ethylhexyl methoxycinnamate, titanium dioxide, ethylhexyl salicylate

Section 51945-4

Warning

for external use only

do not use on damaged or broken skin

Active Ingredient

ethylhexyl methoxycinnamate, titanium dioxide, ethylhexyl salicylate

Inactive Ingredient

water, dpropylene glycol, butylene glycol, etc

Indication & Usage Section

apply liberally 15 minutes before sun exposure

reapply at least every 2 hours

Keep Out of Reach of Children

Keep out of reach of children.

Structured Label Content

Uses (USES)

for external use only

Purpose (PURPOSE)

helps prevent sunburn

Section 51945-4 (51945-4)

Warning (WARNING)

for external use only

do not use on damaged or broken skin

Active Ingredient (ACTIVE INGREDIENT)

ethylhexyl methoxycinnamate, titanium dioxide, ethylhexyl salicylate

Inactive Ingredient (INACTIVE INGREDIENT)

water, dpropylene glycol, butylene glycol, etc

Indication & Usage Section (INDICATION & USAGE SECTION)

apply liberally 15 minutes before sun exposure

reapply at least every 2 hours

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

Keep out of reach of children.

Advanced Ingredient Data

[{"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "4.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"USES": "for external use only", "PURPOSE": "helps prevent sunburn", "WARNING": "for external use only do not use on damaged or broken skin", "ACTIVE INGREDIENT": "ethylhexyl methoxycinnamate, titanium dioxide, ethylhexyl salicylate", "INACTIVE INGREDIENT": "water, dpropylene glycol, butylene glycol, etc", "INDICATION & USAGE SECTION": "apply liberally 15 minutes before sun exposure reapply at least every 2 hours", "KEEP OUT OF REACH OF CHILDREN": "Keep out of reach of children."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:27.458600 · Updated: 2026-03-14T22:59:26.836242