SPL v3
SPL
SPL Set ID 240d21b9-6dcf-4990-b8a2-7791246d563c
Route
TOPICAL
Published
Effective Date 2016-06-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (5 g)
Inactive Ingredients
Dimethicone Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Triisostearin Petrolatum Glyceryl Monobehenate .alpha.-tocopherol Acetate Aluminum Hydroxide Stearic Acid Aloe Vera Leaf Ovis Aries Placenta

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-12-01

Description

Titanium Dioxide 5%

Purpose

SUNSCREEN


Medication Information

Purpose

SUNSCREEN

Description

Titanium Dioxide 5%

Uses

Helps prevent sunburn.

Section 51945-4

Warnings

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

Sun Alert

Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Directions

Apply generously 15 minutes before sun exposure. Reapply at least every 2 hours. For use on children less than 6 months of age, consult a health care professional. Use a water resistant sunscreen if swimming or sweating.

Active Ingredient

Titanium Dioxide 5%

Inactive Ingredients

Dimethicone, Dimethicone Crosspolymer, Petrolatum, Triisostearin, Glyceryl Behenate, Tocopheryl Acetate, Aluminum Hydroxide, Stearic Acid, Aloe Barbadensis Leaf Extract, Placental Protein, Fragrance


Structured Label Content

Uses (USES)

Helps prevent sunburn.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

SUNSCREEN

Warnings (WARNINGS)

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

Sun Alert

Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Directions (DIRECTIONS)

Apply generously 15 minutes before sun exposure. Reapply at least every 2 hours. For use on children less than 6 months of age, consult a health care professional. Use a water resistant sunscreen if swimming or sweating.

Active Ingredient (ACTIVE INGREDIENT)

Titanium Dioxide 5%

Inactive Ingredients (INACTIVE INGREDIENTS)

Dimethicone, Dimethicone Crosspolymer, Petrolatum, Triisostearin, Glyceryl Behenate, Tocopheryl Acetate, Aluminum Hydroxide, Stearic Acid, Aloe Barbadensis Leaf Extract, Placental Protein, Fragrance


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)