SPL v2
SPL
SPL Set ID 3aadc018-edbb-033b-e063-6394a90afbe7
Route
TOPICAL
Published
Effective Date 2024-08-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-02

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 Ingredient(s)

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: (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 (PURPOSE)

SUNSCREEN

Warning (WARNING)

KEEP OUT OF REACH OF CHILDREN

Warnings (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 (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 (OTHER INFORMATION)

Protect this product from excessive heat and direct sun

May stain some fabrics

Active Ingredient(s) (ACTIVE INGREDIENT(S))

Zinc Oxide 16%

Inactive Ingredients (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

All Sections (JSON)