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
Description

ethylhexyl methoxycinnamate, titanium dioxide, ethylhexyl salicylate

Purpose

helps prevent sunburn

Medication Information

Purpose

helps prevent sunburn

Description

ethylhexyl methoxycinnamate, titanium dioxide, ethylhexyl salicylate

Uses

for external use only

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

Section 51945-4 (51945-4)

Purpose (PURPOSE)

helps prevent sunburn

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

Raw Label Data

All Sections (JSON)

Additional Information

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