SPL v1
SPL
SPL Set ID d4078290-b8bb-4be7-99a7-833fe3b7fa36
Route
TOPICAL
Published
Effective Date 2012-10-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (1.88 g) Octinoxate (1.5 g) Zinc Oxide (0.48 g)
Inactive Ingredients
Cetyl Ethylhexanoate Octyldodecyl Myristate Mica Talc

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-03-01
Description

ACTIVE INGREDIENTS: Titanium Dioxide 7.54%, Ethylhexyl Methoxycinnamate 6.00%, Zinc Oxide 1.92%

Indications and Usage

INDICATION AND USAGE: Apply as desired with encased puff.

Purpose

PURPOSE: This combination of Cosmetic / OTC Drug can be used as a sun protection cream

Dosage and Administration

DOSAGE AND ADMINISTRATION: Use appropriate amount according to your skin condition and apply as you desire.

Medication Information

Indications and Usage

INDICATION AND USAGE: Apply as desired with encased puff.

Purpose

PURPOSE: This combination of Cosmetic / OTC Drug can be used as a sun protection cream

Dosage and Administration

DOSAGE AND ADMINISTRATION: Use appropriate amount according to your skin condition and apply as you desire.

Description

ACTIVE INGREDIENTS: Titanium Dioxide 7.54%, Ethylhexyl Methoxycinnamate 6.00%, Zinc Oxide 1.92%

Warnings

WARNING:

For external use only.

Do not swallow.

Keep out of reach of children.

Avoid contact with eyes.

Do not use on exposed wounds or if you are allergic to any ingredients of this product.

Active Ingredient

ACTIVE INGREDIENTS: Titanium Dioxide 7.54%, Ethylhexyl Methoxycinnamate 6.00%, Zinc Oxide 1.92%

Inactive Ingredient

INACTIVE INGREDIENTS:

Cetyl Ethylhexanoate, Octyldodecyl Myristate, Mica, Polyethylene, Zea Mays (Corn) Starch, Microcrystalline Wax, 4-Methylbenzylidene Camphor, Punica Granatum Seed Oil, Camellia Sinensis Seed Oil, Vitis Vinifera (Grape) Seed Oil, Prunus Armeniaca (Apricot) Kernel Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Talc, Methicone, Hydrogen Dimethicone, BHT, Tin Oxide, Carmine, Caprylyl Glycol, Ethylhexylglycerin, Fragrance

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label. Principal Display Panel

Structured Label Content

Purpose (PURPOSE)

PURPOSE: This combination of Cosmetic / OTC Drug can be used as a sun protection cream

Warnings (WARNINGS)

WARNING:

For external use only.

Do not swallow.

Keep out of reach of children.

Avoid contact with eyes.

Do not use on exposed wounds or if you are allergic to any ingredients of this product.

Active Ingredient (ACTIVE INGREDIENT)

ACTIVE INGREDIENTS: Titanium Dioxide 7.54%, Ethylhexyl Methoxycinnamate 6.00%, Zinc Oxide 1.92%

Inactive Ingredient (INACTIVE INGREDIENT)

INACTIVE INGREDIENTS:

Cetyl Ethylhexanoate, Octyldodecyl Myristate, Mica, Polyethylene, Zea Mays (Corn) Starch, Microcrystalline Wax, 4-Methylbenzylidene Camphor, Punica Granatum Seed Oil, Camellia Sinensis Seed Oil, Vitis Vinifera (Grape) Seed Oil, Prunus Armeniaca (Apricot) Kernel Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Talc, Methicone, Hydrogen Dimethicone, BHT, Tin Oxide, Carmine, Caprylyl Glycol, Ethylhexylglycerin, Fragrance

Indications and Usage (INDICATIONS AND USAGE)

INDICATION AND USAGE: Apply as desired with encased puff.

Dosage and Administration (DOSAGE AND ADMINISTRATION)

DOSAGE AND ADMINISTRATION: Use appropriate amount according to your skin condition and apply as you desire.

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

KEEP OUT OF REACH OF CHILDREN

Package Label. Principal Display Panel (PACKAGE LABEL. PRINCIPAL DISPLAY PANEL)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:32.510796 · Updated: 2026-03-14T22:53:18.854428