1740393b-f8a3-475b-e063-6394a90a6fa8

SPL v1
SPL
SPL Set ID 1740393b-f8a3-475b-e063-6394a90a6fa8
Route
topical
Published
Effective Date 2024-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (2.1483 g)
Inactive Ingredients
c30-38 olefin trimethylsiloxysilicate (m/q 0.8-1.0) sodium dehydroacetate ferrosoferric oxide sorbitan isostearate medium-chain triglycerides disteardimonium hectorite water dimethicone caprylyl trisiloxane butylene glycol caprylyl dimethicone ethoxy glucoside titanium dioxide ferric oxide yellow isohexadecane isododecane aluminum oxide methyl trimethicone boron nitride dimethicone/vinyl dimethicone crosspolymer (soft particle) dimethicone/vinyl dimethicone crosspolymer (hard particle) alcohol silicon dioxide potassium sorbate di-c12-13 alkyl tartrate triethoxycaprylylsilane powdered cellulose pomegranate fruit rind sodium chloride glycerin phenoxyethanol ferric oxide red .alpha.-tocopherol acetate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-05-01
Description

Drug Facts

Medication Information

Warnings

For external use only.

Active Ingredient

Zinc Oxide 6.2%

Uses

• helps prevent sunburn

• 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.

Directions

• For sunscreen use:

• apply liberally 15 minutes before sun exposure • use a water resistant sunscreen if swimming or sweating • reapply at least every 2 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 a.m. – 2p.m • wear long-sleeve shirts, pants, hats, and sunglasses.

• children under 6 months of age: Ask a doctor

Inactive Ingredients

water, dimethicone, trimethylsiloxysilicate, caprylyl methicone, butylene glycol, isohexadecane, caprylyl dimethicone ethoxy glucoside, methyl trimethicone, isododecane, sorbitan isostearate, dimethicone/vinyl dimethicone crosspolymer, bis-hydroxyethoxypropyl dimethicone/ipdi copolymer ethylcarbamate, boron nitride, punica granatum pericarp extract, glycerin, polysilicone-11, phenoxyethanol,sodium chloride, cellulose, polyphenylsilsesquioxane, silica, triethoxycaprylylsilane, alcohol, di-c12-13 alkyl tartrate, disteardimonium hectorite, potassium sorbate, sodium dehydroacetate, caprylic/capric triglyceride, tocopheryl acetate, alumina, lauryl dimethicone, c20-24 olefin. may contain: iron oxides (CI 77491,CI 77492,CI 77499), titanium dioxide (CI 77891).

Description

Drug Facts

Questions?

Call toll free 1-888-795-4747

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50567-7

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

Section 50570-1

Do not use on damaged or broken skin.

Section 51945-4

Section 55105-1

Active Ingredients Purpose

Zinc Oxide 6.2% Sunscreen

Section 60561-8

Protect the product in this container from excessive heat and direct sun.

Structured Label Content

Warnings

For external use only.

Active Ingredient (55106-9)

Zinc Oxide 6.2%

Uses

• helps prevent sunburn

• 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.

Directions

• For sunscreen use:

• apply liberally 15 minutes before sun exposure • use a water resistant sunscreen if swimming or sweating • reapply at least every 2 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 a.m. – 2p.m • wear long-sleeve shirts, pants, hats, and sunglasses.

• children under 6 months of age: Ask a doctor

Inactive Ingredients

water, dimethicone, trimethylsiloxysilicate, caprylyl methicone, butylene glycol, isohexadecane, caprylyl dimethicone ethoxy glucoside, methyl trimethicone, isododecane, sorbitan isostearate, dimethicone/vinyl dimethicone crosspolymer, bis-hydroxyethoxypropyl dimethicone/ipdi copolymer ethylcarbamate, boron nitride, punica granatum pericarp extract, glycerin, polysilicone-11, phenoxyethanol,sodium chloride, cellulose, polyphenylsilsesquioxane, silica, triethoxycaprylylsilane, alcohol, di-c12-13 alkyl tartrate, disteardimonium hectorite, potassium sorbate, sodium dehydroacetate, caprylic/capric triglyceride, tocopheryl acetate, alumina, lauryl dimethicone, c20-24 olefin. may contain: iron oxides (CI 77491,CI 77492,CI 77499), titanium dioxide (CI 77891).

Questions?

Call toll free 1-888-795-4747

Section 42229-5 (42229-5)

Drug Facts

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 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Active Ingredients Purpose

Zinc Oxide 6.2% Sunscreen

Section 60561-8 (60561-8)

Protect the product in this container from excessive heat and direct sun.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:13.023117 · Updated: 2026-03-14T23:03:09.210552