SPL v1
SPL
SPL Set ID 4057b0e2-1c31-abae-e063-6294a90a053d
Route
TOPICAL
Published
Effective Date 2025-10-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (7.2 g)
Inactive Ingredients
Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Ci 45370 Stearyl Trisiloxane Bht Alpha-tocopherol Acetate Paraffin Hydrogenated Polyisobutene 8 Mica Ci 45380 C12-15 Alkyl Benzoate Tridecyl Trimellitate Tribehenin Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate Microcrystalline Wax Phenyl Methicone (500 Cst) Water Phenoxyethanol Triethoxycaprylylsilane Cetyl Dimethicone/bis-vinyldimethicone Crosspolymer Silica Dimethyl Silylate Disteardimonium Hectorite Ethylhexylglycerin Ethylhexyl Palmitate Silica Ci 77491 Sorbitan Isostearate Flavor Spice Mint N&a110589

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-04

Description

Zinc Oxide 7.2%


Medication Information

Warnings and Precautions

For external use only

When using this product keep out of eyes.

Rinse with water to remove - do not use on broken skin.

Indications and Usage

■Apply liberally and evenly 15 minutes before sun exposure.

■Reapply at least every two hours.

■Sun Protection Measures: Spending time in the sun increases

your risk of skin cancer and early skin aging. To decrease 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 PM

• wear long sleeve shirts, pants, hats, and sunglasses

Dosage and Administration

■Apply liberally and evenly 15 minutes before sun exposure.

■Reapply at least every two hours.

■Sun Protection Measures: Spending time in the sun increases

Description

Zinc Oxide 7.2%

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

POLYISOBUTENE

TRIDECYL TRIMELLITATE

PHENYL METHICONE

C12-15 ALKYL BENZOATE

CETYL DIMETHICONE

ETHYLHEXYL PALMITATE

SILICA

TRIETHOXYCAPRYLYLSILANE

CETYL PEG/PPG-10/1 DIMETHICONE

PENTAERYTHRITYL TETRA-DI-t-BUTYL HYDROXYHYDROCINNAMATE

CERA MICROCRISTALLINA

PARAFFIN

STEARYL DIMETHICONE

TRIBEHENIN

CERA MICROCRISTALLINA

FLAVOR

SILICA DIMETHYL SILYLATE

CI 77019

CI 77491

DISTEARDIMONIUM HECTORITE

WATER

PHENOXYETHANOL

ETHYLHEXYLGLYCERIN

SORBITAN ISOSTEARATE

TOCOPHERYL ACETATE

CI 45370

BHT

CI 45380

Section 51945-4

Section 55105-1

Helps prevent sunburn.

Section 55106-9

Zinc Oxide 7.2%


Structured Label Content

Indications and Usage (34067-9)

■Apply liberally and evenly 15 minutes before sun exposure.

■Reapply at least every two hours.

■Sun Protection Measures: Spending time in the sun increases

your risk of skin cancer and early skin aging. To decrease 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 PM

• wear long sleeve shirts, pants, hats, and sunglasses

Dosage and Administration (34068-7)

■Apply liberally and evenly 15 minutes before sun exposure.

■Reapply at least every two hours.

■Sun Protection Measures: Spending time in the sun increases

Warnings and Precautions (34071-1)

For external use only

When using this product keep out of eyes.

Rinse with water to remove - do not use on broken skin.

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

POLYISOBUTENE

TRIDECYL TRIMELLITATE

PHENYL METHICONE

C12-15 ALKYL BENZOATE

CETYL DIMETHICONE

ETHYLHEXYL PALMITATE

SILICA

TRIETHOXYCAPRYLYLSILANE

CETYL PEG/PPG-10/1 DIMETHICONE

PENTAERYTHRITYL TETRA-DI-t-BUTYL HYDROXYHYDROCINNAMATE

CERA MICROCRISTALLINA

PARAFFIN

STEARYL DIMETHICONE

TRIBEHENIN

CERA MICROCRISTALLINA

FLAVOR

SILICA DIMETHYL SILYLATE

CI 77019

CI 77491

DISTEARDIMONIUM HECTORITE

WATER

PHENOXYETHANOL

ETHYLHEXYLGLYCERIN

SORBITAN ISOSTEARATE

TOCOPHERYL ACETATE

CI 45370

BHT

CI 45380

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Helps prevent sunburn.

Section 55106-9 (55106-9)

Zinc Oxide 7.2%


Advanced Ingredient Data


Raw Label Data

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