SPL v1
SPL
SPL Set ID 40024b26-6117-7bae-e063-6294a90a33eb
Route
TOPICAL
Published
Effective Date 2025-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ethylhexyl Methoxycinnamate (1.5 g) Zinc Oxide (3 g)
Inactive Ingredients
Petrolatum Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Peg-7 Trimethylolpropane Coconut Ether Isopropyl Palmitate Polyether-1 (2800 Mpa.s) .alpha.-butyldimethylsilyl-and .omega.-3-methacryloxypropyldimethylsilyl-terminated Polydimethylsiloxane (10000 Mw) Citric Acid Water Polyisobutylene (1000 Mw) Sodium Hyaluronate 1,2-butanediol Iodopropynyl Butylcarbamate Cetearyl Glucoside .alpha.-tocopherol Acetate Triethoxycaprylylsilane Phenoxyethanol

Identifiers & Packaging

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

Description

ETHYLHEXYL METHOXYCINNAMATE ZINC OXIDE

Purpose

SUNSCREEN


Medication Information

Purpose

SUNSCREEN

Description

ETHYLHEXYL METHOXYCINNAMATE ZINC OXIDE

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

ETHYLHEXYL METHOXYCINNAMATE

ZINC OXIDE

Inactive Ingredients

WATER

PETROLATUM

ISOPROPYL PALMITATE

CETEARYL GLUCOSIDE

POLYDIMETHYLSILOXANE

HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER

POLYISOBUTYLENE

PEG-7 TRIMETHYLOLPROPANE COCONUT ETHER

SODIUM HYALURONATE

TOCOPHERYL ACETATE

POLYETHER-1

CITRIC ACID

OLEANOL POLYETHER-3 PHOSPHATE

PHENOXYETHANOL

BUTANEDIOL

IODOPROPYNYL BUTYLCARBAMATE

TRIETHOXYOCTYLSILANE

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

ETHYLHEXYL METHOXYCINNAMATE

ZINC OXIDE

Inactive Ingredients (Inactive ingredients)

WATER

PETROLATUM

ISOPROPYL PALMITATE

CETEARYL GLUCOSIDE

POLYDIMETHYLSILOXANE

HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER

POLYISOBUTYLENE

PEG-7 TRIMETHYLOLPROPANE COCONUT ETHER

SODIUM HYALURONATE

TOCOPHERYL ACETATE

POLYETHER-1

CITRIC ACID

OLEANOL POLYETHER-3 PHOSPHATE

PHENOXYETHANOL

BUTANEDIOL

IODOPROPYNYL BUTYLCARBAMATE

TRIETHOXYOCTYLSILANE

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)