Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 154c9375-7238-4721-8e0d-6383123b99d0
Route
TOPICAL
Published
Effective Date 2011-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (5 g) Zinc Oxide (15 g)
Inactive Ingredients
Water Almond Oil Sesame Oil Soybean Oil Jojoba Oil Cetearyl Olivate Sorbitan Olivate Stearic Acid Aloe Vera Leaf Alpha-tocopherol Sodium Benzoate Cetyl Alcohol Wheat Germ Oil Dexpanthenol Olea Europaea Leaf Carrot Green Tea Leaf Licorice Azadirachta Indica Flower Cucumber Glyceryl Monostearate Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-11-14

Description

Active ingredients Titanium dioxide 5% Zinc Oxide 15% purpose Sunscreen Uses   • Helps prevent sunburn Warnings: Skin Cancer/Skin Aging Alert : Spending time in the sun increase your risk of skin cancer and early skin aging.This product has been shown only to prevent sunburn,not skin cancer or early skin aging For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs Keep out of reach of children . If product is swallowed, get medical help or contact a Poison Control Center right away. Directions • apply liberally 15 minutes before sun exposure • reapply:    • after 40 minutes of swimming or sweating    • immediately after towel drying    • at least every 2 hours • children under 6 months: Ask a doctor Inactive ingredients water, Almond oil, Sesame oil, Soy bean oil, Jojoba oil, Cetearyl olivate, sorbitan olivate, Stearic acid, Aloevera, Vitamin E oil, Sodium Benzoate, Cetyl Alcohol, Whetgerm oil, D Panthanol, Olive leaf extract, fragrance, Carrot extract, Green tea extract, Licorice extract, Neem extract, Cucumber extract, Glyceryl stearate, Xanthan gum Other information • protect this product from excessive heat and direct sun Questions or comments? Call toll free 1-866-855-9006


Medication Information

Description

Active ingredients Titanium dioxide 5% Zinc Oxide 15% purpose Sunscreen Uses   • Helps prevent sunburn Warnings: Skin Cancer/Skin Aging Alert : Spending time in the sun increase your risk of skin cancer and early skin aging.This product has been shown only to prevent sunburn,not skin cancer or early skin aging For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs Keep out of reach of children . If product is swallowed, get medical help or contact a Poison Control Center right away. Directions • apply liberally 15 minutes before sun exposure • reapply:    • after 40 minutes of swimming or sweating    • immediately after towel drying    • at least every 2 hours • children under 6 months: Ask a doctor Inactive ingredients water, Almond oil, Sesame oil, Soy bean oil, Jojoba oil, Cetearyl olivate, sorbitan olivate, Stearic acid, Aloevera, Vitamin E oil, Sodium Benzoate, Cetyl Alcohol, Whetgerm oil, D Panthanol, Olive leaf extract, fragrance, Carrot extract, Green tea extract, Licorice extract, Neem extract, Cucumber extract, Glyceryl stearate, Xanthan gum Other information • protect this product from excessive heat and direct sun Questions or comments? Call toll free 1-866-855-9006

Section 51945-4

   

Section 55106-9

Active ingredients

Titanium dioxide 5%

Zinc Oxide 15%

purpose

Sunscreen

Uses 

• Helps prevent sunburn

Warnings:

Skin Cancer/Skin Aging Alert: Spending time in the sun increase

your risk of skin cancer and early skin aging.This product has been

shown only to prevent sunburn,not skin cancer or early skin aging

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical

help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure

• reapply:

   • after 40 minutes of swimming or sweating

   • immediately after towel drying

   • at least every 2 hours

• children under 6 months: Ask a doctor

Inactive ingredients

water, Almond oil, Sesame oil, Soy bean oil, Jojoba oil, Cetearyl olivate, sorbitan olivate, Stearic acid,

Aloevera, Vitamin E oil, Sodium Benzoate, Cetyl Alcohol, Whetgerm oil, D Panthanol, Olive leaf extract,

fragrance, Carrot extract, Green tea extract, Licorice extract, Neem extract, Cucumber extract, Glyceryl

stearate, Xanthan gum

Other information

• protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-866-855-9006


Structured Label Content

Section 51945-4 (51945-4)

   

Section 55106-9 (55106-9)

Active ingredients

Titanium dioxide 5%

Zinc Oxide 15%

purpose

Sunscreen

Uses 

• Helps prevent sunburn

Warnings:

Skin Cancer/Skin Aging Alert: Spending time in the sun increase

your risk of skin cancer and early skin aging.This product has been

shown only to prevent sunburn,not skin cancer or early skin aging

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical

help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure

• reapply:

   • after 40 minutes of swimming or sweating

   • immediately after towel drying

   • at least every 2 hours

• children under 6 months: Ask a doctor

Inactive ingredients

water, Almond oil, Sesame oil, Soy bean oil, Jojoba oil, Cetearyl olivate, sorbitan olivate, Stearic acid,

Aloevera, Vitamin E oil, Sodium Benzoate, Cetyl Alcohol, Whetgerm oil, D Panthanol, Olive leaf extract,

fragrance, Carrot extract, Green tea extract, Licorice extract, Neem extract, Cucumber extract, Glyceryl

stearate, Xanthan gum

Other information

• protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-866-855-9006


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)