Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 039e50c1-7b3d-d392-e063-6394a90a4b3c
Route
TOPICAL
Published
Effective Date 2023-08-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (6 g) Titanium Dioxide (4.7 g)
Inactive Ingredients
Ethylhexylglycerin Water Aluminum Hydroxide Prunus Persica Seed Stearic Acid Dimethicone Cyclomethicone 6 Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Glycerin Hexyl Laurate Resveratrol Cetyl Peg/ppg-10/1 Dimethicone (hlb 4) Cetearyl Olivate Sodium Chloride Caprylyl Glycol Polyglyceryl-4 Isostearate Panthenol Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone Dimethicone/peg-10/15 Crosspolymer Hyaluronate Sodium Hexylene Glycol Sorbitan Olivate Alkyl (c12-15) Benzoate .alpha.-tocopherol Acetate Cyclomethicone 7 Dimethicone/polyglycerin-3 Crosspolymer Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-23
Description

ACTIVE INGREDIENTS: Zinc Oxide - 6.0% Titanium Dioxide 4.7%

Medication Information

Warnings and Precautions

Warning:

For external use only

Indications and Usage

Uses: Helps prevent sunburn. If used as directed with other sun protection measures, this product decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration

Direction:

Apply liberally 15 minutes before sun exposure.

Children under 6 month of age: Ask a doctor

Reapply at least every 2 hours.

Sun protection measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decreases this risk regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun< especially from 10 am – 2.0 pm, Wear long – sleeved shirts, pants, hats and sunglasses.

Description

ACTIVE INGREDIENTS: Zinc Oxide - 6.0% Titanium Dioxide 4.7%

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 eye. Rinse with water to remove.

Section 50570-1

Do not use on damage or broken skin.

Section 51727-6

INACTIVE INGREDIENT: Water, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Dimethicone, Cyclohexasiloxane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Aluminum Hydroxide, Stearic Acid, Glycerin, Cetearyl Olivate,Hexyl Laurate, Sodium Chloride, Pichia/ Resveratrol, Ferment Extract, Sorbitane Olivate, Dimethicone/Polyglycerin -3 Crosspolymer, Polyglyceryl-4 Isostearate, Panthenol, Cetyl PEG/PPG-10/1 Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl HexylDimethicone, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Venyl Dimethicone, Crosspolymer, Sodium Hyaluronate, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Fragrance, Tocopheryl Acetate.

Section 51945-4

Section 55105-1

Purpose: Sunscreen

Section 55106-9

ACTIVE INGREDIENTS:

Zinc Oxide - 6.0%

Titanium Dioxide 4.7%

Section 60561-8

Other Information:

Protect the product in this container from excessive heat and direct sun.

Structured Label Content

Indications and Usage (34067-9)

Uses: Helps prevent sunburn. If used as directed with other sun protection measures, this product decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration (34068-7)

Direction:

Apply liberally 15 minutes before sun exposure.

Children under 6 month of age: Ask a doctor

Reapply at least every 2 hours.

Sun protection measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decreases this risk regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun< especially from 10 am – 2.0 pm, Wear long – sleeved shirts, pants, hats and sunglasses.

Warnings and Precautions (34071-1)

Warning:

For external use only

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 eye. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damage or broken skin.

Section 51727-6 (51727-6)

INACTIVE INGREDIENT: Water, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Dimethicone, Cyclohexasiloxane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Aluminum Hydroxide, Stearic Acid, Glycerin, Cetearyl Olivate,Hexyl Laurate, Sodium Chloride, Pichia/ Resveratrol, Ferment Extract, Sorbitane Olivate, Dimethicone/Polyglycerin -3 Crosspolymer, Polyglyceryl-4 Isostearate, Panthenol, Cetyl PEG/PPG-10/1 Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl HexylDimethicone, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Venyl Dimethicone, Crosspolymer, Sodium Hyaluronate, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Fragrance, Tocopheryl Acetate.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Sunscreen

Section 55106-9 (55106-9)

ACTIVE INGREDIENTS:

Zinc Oxide - 6.0%

Titanium Dioxide 4.7%

Section 60561-8 (60561-8)

Other Information:

Protect the product in this container from excessive heat and direct sun.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:40.816519 · Updated: 2026-03-14T23:05:35.877028