SPL v2
SPL
SPL Set ID 42674013-fa2b-42d7-e063-6294a90af999
Route
TOPICAL
Published
Effective Date 2020-10-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (80 mg) Zinc Oxide (38 mg)
Inactive Ingredients
Peg-10 Dimethicone (600 Cst) Dimethicone Crosspolymer Alumina Cyclopentasiloxane Cyclohexasiloxane Dimethiconol (2000 Cst) Lauryl Peg/ppg-18/18 Methicone Tetrahexyldecyl Ascorbate Dimethicone Alpha-tocopherol Acetate Hydrogen Dimethicone (20 Cst) Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-10-12

Description

Titanium Dioxide 8% Zinc Oxide 3.8%

Purpose

SUNSCREEN


Medication Information

Purpose

SUNSCREEN

Description

Titanium Dioxide 8% Zinc Oxide 3.8%

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

• Cleanse thoroughly at nighttime

• PA++++

Active Ingredient(s

Titanium Dioxide 8% Zinc Oxide 3.8%

Inactive Ingredients

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate


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

• Cleanse thoroughly at nighttime

• PA++++

Active Ingredient(s (ACTIVE INGREDIENT(S)

Titanium Dioxide 8% Zinc Oxide 3.8%

Inactive Ingredients (INACTIVE INGREDIENTS)

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate


Advanced Ingredient Data


Raw Label Data

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