SPL v1
SPL
SPL Set ID 2f7fb686-d615-fc1c-e063-6394a90aa1bb
Route
TOPICAL
Published
Effective Date 2025-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (10 mg)
Inactive Ingredients
Dimethicone Polyacrylamide (1500 Mw) Cyclopentasiloxane Fragrance 13576 Trimethylsiloxysilicate (m/q 0.8-1.0) Sorbitan Sesquioleate Polysorbate 60 Stearic Acid Methylparaben Ci 77891 Phenoxyethanol Water Allantoin Glycerin Ci 77491 Dipropylene Glycol Ci 77492 Sodium Acrylate/sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) Triethoxycaprylylsilane Isohexadecane Ethylhexyl Palmitate Sorbitan Oleate Edetate Disodium Cyclohexasiloxane Laureth-7 Alumina Caprylhydroxamic Acid Ethylhexylglycerin C13-14 Isoparaffin Polysorbate 80

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-04

Description

Zinc Oxide -----10%


Medication Information

Warnings and Precautions

For external use only

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse 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 contacta Poison Control Center right away.

Indications and Usage

.Apply liberally 15 minutes exposure.

.Reapply after 40 minutes of swimmingor sweating immediately after toweldrying at least every 2 hours

Dosage and Administration

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 sub and other sun protection measures including:

Limit time in the sun, especially from 10 a.m.- 2 p.m.

Wear long-sleeved shirts, pants, hats and sunglasses

Children under 6 months: Ask a doctor

Description

Zinc Oxide -----10%

Section 50565-1

Keep out of reach of children

Section 51727-6

WATER,GLYCERIN,ETHYLHEXYL PALMITATE,STEARIC ACID,CI 77891,CYCLOPENTASILOXANE,SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER,DIMETHICONE,PROPYLENE GLYCOL,ISOHEXADECANE,PHENOXYETHANOL,POLYACRYLAMIDE,CYCLOHEXASILOXANE,METHYLPARABEN,C13-14 ISOPARAFFIN,POLYSORBATE 80,CI 77492,SORBITAN SESQUIOLEATE,POLYSORBATE 60,ALLANTOIN,FRAGRANCE,SORBITAN OLEATE,LAURETH-7,ALUMINA,DISODIUM EDTA,TRIETHOXYCAPRYLYLSILANE,CI 77491,ETHYLHEXYLGLYCERIN,TRIMETHYLSILOXYSILICATE,CAPRYLHYDROXAMIC ACID

Section 51945-4

Section 55105-1

Helps prevent sunburn

If used as directed with other sun protection measures (see Directions), decreases the risk of skincancer and early skin aging caused by the sun

Section 55106-9

Zinc Oxide -----10%


Structured Label Content

Indications and Usage (34067-9)

.Apply liberally 15 minutes exposure.

.Reapply after 40 minutes of swimmingor sweating immediately after toweldrying at least every 2 hours

Dosage and Administration (34068-7)

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 sub and other sun protection measures including:

Limit time in the sun, especially from 10 a.m.- 2 p.m.

Wear long-sleeved shirts, pants, hats and sunglasses

Children under 6 months: Ask a doctor

Warnings and Precautions (34071-1)

For external use only

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse 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 contacta Poison Control Center right away.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

WATER,GLYCERIN,ETHYLHEXYL PALMITATE,STEARIC ACID,CI 77891,CYCLOPENTASILOXANE,SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER,DIMETHICONE,PROPYLENE GLYCOL,ISOHEXADECANE,PHENOXYETHANOL,POLYACRYLAMIDE,CYCLOHEXASILOXANE,METHYLPARABEN,C13-14 ISOPARAFFIN,POLYSORBATE 80,CI 77492,SORBITAN SESQUIOLEATE,POLYSORBATE 60,ALLANTOIN,FRAGRANCE,SORBITAN OLEATE,LAURETH-7,ALUMINA,DISODIUM EDTA,TRIETHOXYCAPRYLYLSILANE,CI 77491,ETHYLHEXYLGLYCERIN,TRIMETHYLSILOXYSILICATE,CAPRYLHYDROXAMIC ACID

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Helps prevent sunburn

If used as directed with other sun protection measures (see Directions), decreases the risk of skincancer and early skin aging caused by the sun

Section 55106-9 (55106-9)

Zinc Oxide -----10%


Advanced Ingredient Data


Raw Label Data

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