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

Description

Drug Facts

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.

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 55106-9

Zinc Oxide 6.2%

Section 60561-8

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

Warnings

For external use only.

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

Questions?

Call toll free 1-888-795-4747

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).

Structured Label Content

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.

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 55106-9 (55106-9)

Zinc Oxide 6.2%

Section 60561-8 (60561-8)

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

Warnings

For external use only.

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

Questions?

Call toll free 1-888-795-4747

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).

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

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