SPL v2
SPL
SPL Set ID 3b3f19c1-4bff-315f-e063-6394a90a9a85
Route
TOPICAL
Published
Effective Date 2021-07-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (160 mg)
Inactive Ingredients
Ci 77491 Tetrahexyldecyl Ascorbate Dimethicone Crosspolymer Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Ci 77492 Peg-10 Dimethicone (600 Cst) Alpha-tocopherol Acetate Ci 77499 Cyclopentasiloxane Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Dimethiconol (2000 Cst) Hydrogen Dimethicone (20 Cst) Caprylic/capric Triglyceride Dimethicone Ceramide 3 Polyhydroxystearic Acid (2300 Mw) Cyclohexasiloxane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-07-13

Description

Zinc Oxide 16%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 16%

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 51945-4

Warning

Keep out of reach of children

Warnings

For external use only. Do not use on broken or damaged skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

Apply liberally 15 minutes before sun exposure. Use a water-resistant product if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: Ask a doctor. 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. - 2 p.m. Wear long-sleeved shirts, pants, hats and sunglasses.

Other Information

Protect this product from excessive heat and direct sun

May stain some fabrics

Active Ingredients

Zinc Oxide 16%

Inactive Ingredients

Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide, Hydrogen Dimethicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer


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 51945-4 (51945-4)

Purpose

Sunscreen

Warning

Keep out of reach of children

Warnings

For external use only. Do not use on broken or damaged skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

Apply liberally 15 minutes before sun exposure. Use a water-resistant product if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: Ask a doctor. 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. - 2 p.m. Wear long-sleeved shirts, pants, hats and sunglasses.

Other Information

Protect this product from excessive heat and direct sun

May stain some fabrics

Active Ingredients

Zinc Oxide 16%

Inactive Ingredients

Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide, Hydrogen Dimethicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer


Advanced Ingredient Data


Raw Label Data

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