SPL v1
SPL
SPL Set ID 40049f9d-7057-05c2-e063-6294a90acbba
Route
TOPICAL
Published
Effective Date 2025-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (3 g) Titanium Dioxide (2.5 g)
Inactive Ingredients
Ascorbic Acid Sodium Chloride Dimethiconol/trimethylsiloxysilicate Crosspolymer (35/65 W/w; 10000000 Pa.s) Dipropylene Glycol Caprylate Polyglyceryl-2 Triisostearate Phenyl Trimethicone Abies Procera Leaf Dimethicone/vinyl Dimethicone Crosspolymer (hard Particle) Magnesium Stearate Dicaprylyl Carbonate Water Simmondsia Chinensis (jojoba) Seed Oil Dipalmitoylphosphatidylglycerol, Dl- Bentonite Aluminum Hexafluorosilicate Ceramide Np Limosilactobacillus Fermentum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-30

Description

ZINC OXIDE TITANIUM DIOXIDE

Purpose

SUNSCREEN


Medication Information

Purpose

SUNSCREEN

Description

ZINC OXIDE TITANIUM DIOXIDE

Uses

If used as directed with other sun protection measures(see Directions),

decreases the risk of skin cancer and early skin aging caused by the sun.

Section 51945-4

Stop Use

Rinse with wate to remove.

Stop use and ask doctor if rash occurs.

Warnings

For external use only

Do Not Use

Do not use on damaged or broken skin.

When Using

When using this product keep out of eyes.

Active Ingredients

ZINC OXIDE

TITANIUM DIOXIDE

Inactive Ingredients

WATER

GLYCEROL

PROPYLENE GLYCOL

SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL

POLYGLYCERYL-2 TRIISOSTEARATE

PHENYL TRIMETHICONE

DICAPRYLYL CARBONATE

ETHYLHEXYL METHOXYCINNAMATE

TRIMETHYLSILOXYSILICATE

CERA ALBA

DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER

BENTONITE

SODIUM CHLORIDE

ASCORBIC ACID POLYPEPTIDE

CERAMIDE NP

SPHINGOMONAS FERMENT EXTRACT

SILICA

MAGNESIUM STEARATE

PEG-30 DIPOLYHYDROXYSTEARATE

XANTHAN GUM

SODIUM HYALURONATE

BISABOLOL

TOCOPHEROL

PHENOXYETHANOL

ETHYLHEXYLGLYCERIN

SOLANUM LYCOPERSICUM (TOMATO) FRUIT EXTRACT

TREMELLA FUCIFORMIS (MUSHROOM) EXTRACT

LILIUM CANDIDUM FLOWER EXTRACT

DENDROBIUM NOBILE EXTRACT

STEPHANIA TETRANDRA EXTRACT

TARAXACUM OFFICINALE (DANDELION) LEAF EXTRACT

SAURURUS CHINENSIS LEAF/ROOT EXTRACT

CI 77492

CI 77491

CI 77499

PARFUM

Dosage & Administration

Squeeze out an appropriate amount of Sunscreen and spread evenly on skin.

Keep Out of Reach of Children

Keep Out Of Reach Of Children


Structured Label Content

Uses

If used as directed with other sun protection measures(see Directions),

decreases the risk of skin cancer and early skin aging caused by the sun.

Section 51945-4 (51945-4)

Purpose

SUNSCREEN

Stop Use

Rinse with wate to remove.

Stop use and ask doctor if rash occurs.

Warnings

For external use only

Do Not Use

Do not use on damaged or broken skin.

When Using

When using this product keep out of eyes.

Active Ingredients

ZINC OXIDE

TITANIUM DIOXIDE

Inactive Ingredients (Inactive ingredients)

WATER

GLYCEROL

PROPYLENE GLYCOL

SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL

POLYGLYCERYL-2 TRIISOSTEARATE

PHENYL TRIMETHICONE

DICAPRYLYL CARBONATE

ETHYLHEXYL METHOXYCINNAMATE

TRIMETHYLSILOXYSILICATE

CERA ALBA

DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER

BENTONITE

SODIUM CHLORIDE

ASCORBIC ACID POLYPEPTIDE

CERAMIDE NP

SPHINGOMONAS FERMENT EXTRACT

SILICA

MAGNESIUM STEARATE

PEG-30 DIPOLYHYDROXYSTEARATE

XANTHAN GUM

SODIUM HYALURONATE

BISABOLOL

TOCOPHEROL

PHENOXYETHANOL

ETHYLHEXYLGLYCERIN

SOLANUM LYCOPERSICUM (TOMATO) FRUIT EXTRACT

TREMELLA FUCIFORMIS (MUSHROOM) EXTRACT

LILIUM CANDIDUM FLOWER EXTRACT

DENDROBIUM NOBILE EXTRACT

STEPHANIA TETRANDRA EXTRACT

TARAXACUM OFFICINALE (DANDELION) LEAF EXTRACT

SAURURUS CHINENSIS LEAF/ROOT EXTRACT

CI 77492

CI 77491

CI 77499

PARFUM

Dosage & Administration (Dosage & administration)

Squeeze out an appropriate amount of Sunscreen and spread evenly on skin.

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)