SPL v1
SPL
SPL Set ID 4932ea19-28cc-b245-e063-6394a90ac7aa
Route
TOPICAL
Published
Effective Date 2026-01-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (14.4 g)
Inactive Ingredients
Peg-100 Stearate C12-15 Alkyl Benzoate Edetate Disodium Ci 77499 Glycerin Cetearyl Alcohol Trimethylsiloxysilicate (m/q 0.8-1.0) Ethylhexyl Palmitate Hydroxyacetophenone Aqua Glyceryl Stearate Citrate Glyceryl Glucoside Cellulose Gum Isopropyl Myristate Isohexadecane Butyloctyl Salicylate Triethoxycaprylylsilane Egg Phospholipids Ci 77492 Peg-20 Stearate Polysorbate 80 Sorbitan Oleate Isostearic Acid Polyglyceryl-3 Pentaricinoleate Phenyl Trimethicone Butylene Glycol 1,2-hexanediol Tridecyl Trimellitate Ci 77491 Propylene Glycol Sodium Acrylate/sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) Potassium Cetyl Phosphate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-25

Description

Zinc oxide


Medication Information

Warnings and Precautions

For external use only Do not use on damaged !i or broken skin.

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

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. lf swallowed, get medical help or contact a Poison

ControlCenter right away

Indications and Usage

Reapply: at least every 2 hours or after

80 minutes of swimming or sweating. Sun Protection Measures: $pending time in the

sun increases your risk of skin cancer andearly skin aging. To decrease this risk,

regularly use a sunscreen with a Broad Spectrum SPfof 15 or higher and other sun

protection measures including: limit time in the sun, especiallyfrom 10 a.m.-2 pm, and

wear long-sleeved shirts, pants, hats, and sunglasses. Childrenunder 6 months of age

ask a doctor.

Dosage and Administration

Apply liberally 15 minutes before sun exposure.

Reapply: at least every 2 hours or after 80 minutes of swimming or sweating.

Description

Zinc oxide

Section 50565-1

Keep out of reach of children. lf swallowed, get medical help or contact a Poison - ControlCenter right away

Section 51727-6

WATER

TRIETHOXYCAPRYLYLSILANE

GLYCERIN

PROPYLENE GLYCOL

BUTYLOCTYL SALICYLATE

TRIDECYL TRIMELLITATE

C12-15 ALKYL BENZOATE

SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER

ISOHEXADECANE

POLYSORBATE 80

SORBITAN OLEATE

PEG-20 STEARATE

CETEARYL ALCOHOL

DIMETHICONE

GLYCERYL STEARATE CITRATE

GLYCERYL STEARATE

PEG-100 STEARATE

TRIMETHYLSILOXYSILICATE

CETEARYL ALCOHOL

CELLULOSE GUM

MICROCRYSTALLINE CELLULOSE

PHENYL TRIMETHICONE

POLYHYDROXYSTEARIC ACID

LECITHIN

ISOPROPYL MYRISTATE

ETHYLHEXYL PALMITATE

ISOSTEARIC ACID

POLYGLYCERYL-3 POLYRICINOLEATE

BUTYLENE GLYCOL

1,2-HEXANEDIOL

HYDROXYACETOPHENONE

GLYCERIN

GLYCERYL GLUCOSIDE

POTASSIUM CETYL PHOSPHATE

XANTHAN GUM

DISODIUM EDTA

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Zinc oxide


Structured Label Content

Indications and Usage (34067-9)

Reapply: at least every 2 hours or after

80 minutes of swimming or sweating. Sun Protection Measures: $pending time in the

sun increases your risk of skin cancer andearly skin aging. To decrease this risk,

regularly use a sunscreen with a Broad Spectrum SPfof 15 or higher and other sun

protection measures including: limit time in the sun, especiallyfrom 10 a.m.-2 pm, and

wear long-sleeved shirts, pants, hats, and sunglasses. Childrenunder 6 months of age

ask a doctor.

Dosage and Administration (34068-7)

Apply liberally 15 minutes before sun exposure.

Reapply: at least every 2 hours or after 80 minutes of swimming or sweating.

Warnings and Precautions (34071-1)

For external use only Do not use on damaged !i or broken skin.

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

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. lf swallowed, get medical help or contact a Poison

ControlCenter right away

Section 50565-1 (50565-1)

Keep out of reach of children. lf swallowed, get medical help or contact a Poison - ControlCenter right away

Section 51727-6 (51727-6)

WATER

TRIETHOXYCAPRYLYLSILANE

GLYCERIN

PROPYLENE GLYCOL

BUTYLOCTYL SALICYLATE

TRIDECYL TRIMELLITATE

C12-15 ALKYL BENZOATE

SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER

ISOHEXADECANE

POLYSORBATE 80

SORBITAN OLEATE

PEG-20 STEARATE

CETEARYL ALCOHOL

DIMETHICONE

GLYCERYL STEARATE CITRATE

GLYCERYL STEARATE

PEG-100 STEARATE

TRIMETHYLSILOXYSILICATE

CETEARYL ALCOHOL

CELLULOSE GUM

MICROCRYSTALLINE CELLULOSE

PHENYL TRIMETHICONE

POLYHYDROXYSTEARIC ACID

LECITHIN

ISOPROPYL MYRISTATE

ETHYLHEXYL PALMITATE

ISOSTEARIC ACID

POLYGLYCERYL-3 POLYRICINOLEATE

BUTYLENE GLYCOL

1,2-HEXANEDIOL

HYDROXYACETOPHENONE

GLYCERIN

GLYCERYL GLUCOSIDE

POTASSIUM CETYL PHOSPHATE

XANTHAN GUM

DISODIUM EDTA

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Zinc oxide


Advanced Ingredient Data


Raw Label Data

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