d4078290-b8bb-4be7-99a7-833fe3b7fa36

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

Indications and Usage

INDICATION AND USAGE: Apply as desired with encased puff.

Dosage and Administration

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

Purpose

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

Description

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

Medication Information

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.

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%

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

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.

Indications and Usage (INDICATIONS AND USAGE)

INDICATION AND USAGE: Apply as desired with encased puff.

Purpose (PURPOSE)

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

Dosage and Administration (DOSAGE AND ADMINISTRATION)

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

Active Ingredient (ACTIVE INGREDIENT)

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

Inactive Ingredient (INACTIVE INGREDIENT)

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

[{"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIM", "strengthNumerator": "1.88", "strengthDenominator": "25", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIM", "strengthNumerator": "1.5", "strengthDenominator": "25", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIM", "strengthNumerator": "0.48", "strengthDenominator": "25", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "Cetyl Ethylhexanoate", "unii": "134647WMX4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Octyldodecyl Myristate", "unii": "S013N99GR8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Mica", "unii": "V8A1AW0880", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Talc", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"PURPOSE": "PURPOSE: This combination of Cosmetic / OTC Drug can be used as a sun protection cream", "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", "INDICATIONS AND USAGE": "INDICATION AND USAGE: Apply as desired with encased puff.", "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"}

Additional Information

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