3b3c757f-6581-4978-e063-6294a90a6173

SPL v2
SPL
SPL Set ID 3b3c757f-6581-4978-e063-6294a90a6173
Route
topical
Published
Effective Date 2019-10-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (80 mg) zinc oxide (38 mg)
Inactive Ingredients
dimethicone/vinyl dimethicone crosspolymer (soft particle) dimethiconol (2000 cst) cyclohexasiloxane hydrogen dimethicone (20 cst) dimethicone alpha-tocopherol acetate peg-10 dimethicone (600 cst) dimethicone crosspolymer tetrahexyldecyl ascorbate ci 77491 cyclopentasiloxane alumina ci 77492 ci 77499 lauryl peg/ppg-18/18 methicone

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-10-24

Purpose

Sunscreen

Description

Titanium Dioxide 8% Zinc Oxide 3.8%


Medication Information

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.

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.

Purpose

Sunscreen

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 thei product from excessive heat and direct sun

May stain some fabrics

Cleanse thoroughly at nighttime

PA++++

Inactive Ingredients

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (CI 77491), Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate

Description

Titanium Dioxide 8% Zinc Oxide 3.8%

Section 51945-4

Warning

Keep out of reach of children

Active Ingredients

Titanium Dioxide 8% Zinc Oxide 3.8%


Structured Label Content

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.

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.

Purpose

Sunscreen

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 thei product from excessive heat and direct sun

May stain some fabrics

Cleanse thoroughly at nighttime

PA++++

Inactive Ingredients

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (CI 77491), Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate

Section 51945-4 (51945-4)

Warning

Keep out of reach of children

Active Ingredients

Titanium Dioxide 8% Zinc Oxide 3.8%


Advanced Ingredient Data


Raw Label Data

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