83447-015

83447-015
SPL v1
SPL
SPL Set ID 47d75d61-5295-3eab-e063-6394a90a01c1
Route
CUTANEOUS
Published
Effective Date 2026-01-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (22 g) Titanium Dioxide (2 g)
Inactive Ingredients
Cyclopentasiloxane Propylene Glycol Silica Rubus Idaeus (raspberry) Seed Oil Potassium Cetyl Phosphate Ceramide Np Dimethicone Squalane Peg-7 Glyceryl Cocoate Polyhydroxystearic Acid Stearate Sodium Hyaluronate Glycerin Leuconostoc/radish Root Ferment Filtrate Butylene Glycol Potassium Sorbate Ci 77492 Ci 77491 Menthol Ci 77499 Isohexadecane Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-08

Description

Zinc Oxide 22% Titanium Dioxide 2%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 22% Titanium Dioxide 2%

Uses

1. Helps prevent sunburn

2. Provides broad-spectrum

UVA/UVB protection

1. ldeal for daily use, especially in outdoor environments

2. Lightweight powder format helps reduce shine and sets makeup

Section 51945-4

Stop Use

Stop use and ask a doctor if rash or irritation occurs.

Warnings

For external use only

Directions

·Apply evenly to clean, dry skin 15 minutes before sun exposure

·Reapply every 2 hours or after sweating, swimming, or towel drying

·Use daily for best results

Do Not Use

Do not use on damaged or broken skin

Keep Out Of

Keep out of reach of children. lf swallowed, seek medical help.

Other Information

Room temperature preservation

Active Ingredients

Zinc Oxide 22%

Titanium Dioxide 2%

Inactive Ingredients

Aloe Barbadensis Leaf Water, Isohexadecane, Cyclopentasiloxane, Propylene Glycol, Silica Microspheres, Rubus

Idaeus (Raspberry) Seed Oil, Potassium Cetyl Phosphate, Lichen Extract, Ceramide NP, Dimethicone, Squalane,

Phytoplankton Extract, PEG-7 Glyceryl Cocoate, Polyhydroxystearic Acid, Sodium Hyaluronate, Glycerin,

Leuconostoc/Radish Root Ferment Filtrate, Butylene Glycol, Potassium Sorbate, CI 77492, CI 77491,

Mentholum, CI 77499

When Using This Product

When using this product, keep out of eyes. Rinse with water to remove.


Structured Label Content

Uses

1. Helps prevent sunburn

2. Provides broad-spectrum

UVA/UVB protection

1. ldeal for daily use, especially in outdoor environments

2. Lightweight powder format helps reduce shine and sets makeup

Section 51945-4 (51945-4)

Purpose

Sunscreen

Stop Use (Stop use)

Stop use and ask a doctor if rash or irritation occurs.

Warnings

For external use only

Directions

·Apply evenly to clean, dry skin 15 minutes before sun exposure

·Reapply every 2 hours or after sweating, swimming, or towel drying

·Use daily for best results

Do Not Use (Do not use)

Do not use on damaged or broken skin

Keep Out Of (Keep out of)

Keep out of reach of children. lf swallowed, seek medical help.

Other Information (Other information)

Room temperature preservation

Active Ingredients (Active ingredients)

Zinc Oxide 22%

Titanium Dioxide 2%

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Water, Isohexadecane, Cyclopentasiloxane, Propylene Glycol, Silica Microspheres, Rubus

Idaeus (Raspberry) Seed Oil, Potassium Cetyl Phosphate, Lichen Extract, Ceramide NP, Dimethicone, Squalane,

Phytoplankton Extract, PEG-7 Glyceryl Cocoate, Polyhydroxystearic Acid, Sodium Hyaluronate, Glycerin,

Leuconostoc/Radish Root Ferment Filtrate, Butylene Glycol, Potassium Sorbate, CI 77492, CI 77491,

Mentholum, CI 77499

When Using This Product (When using this product)

When using this product, keep out of eyes. Rinse with water to remove.


Advanced Ingredient Data


Raw Label Data

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