SPL v2
SPL
SPL Set ID 312e9ca0-a388-a546-e063-6294a90a15d6
Route
TOPICAL
Published
Effective Date 2021-05-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (80 mg) Zinc Oxide (38 mg)
Inactive Ingredients
Ci 77491 Ci 77492 Ci 77499 Dimethiconol (2000 Cst) Peg-10 Dimethicone (600 Cst) Dimethicone Crosspolymer Alumina Cyclopentasiloxane Dimethicone Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Tetrahexyldecyl Ascorbate Alpha-tocopherol Acetate Hydrogen Dimethicone (20 Cst) Lauryl Peg/ppg-18/18 Methicone Cyclohexasiloxane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-05-18

Description

Titanium Dioxide 8% Zinc Oxide 3.8%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 8% Zinc Oxide 3.8%

Uses:

Helps prevents 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

Purpose:

Sunscreen

Warnings:

For external use only. Do not use on damaged or broken 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 the reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions:

• Apply liberally 15 minutes before sun exposure. • Reapply: • After 80 minutes of swimming or sweating • Immediately after towel drying • 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 am-2 pm •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 Ingredients:

Titanium Dioxide 8% Zinc Oxide 3.8%

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


Structured Label Content

Uses:

Helps prevents 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

Warnings:

For external use only. Do not use on damaged or broken 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 the reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions:

• Apply liberally 15 minutes before sun exposure. • Reapply: • After 80 minutes of swimming or sweating • Immediately after towel drying • 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 am-2 pm •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 Ingredients:

Titanium Dioxide 8% Zinc Oxide 3.8%

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


Advanced Ingredient Data


Raw Label Data

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