Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID aec1957a-f68d-4fbd-af9e-f8b257daea46
Route
TOPICAL
Published
Effective Date 2023-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (68 mg)
Inactive Ingredients
Water Undecane Dimethicone Glycerin Tridecane Polyglyceryl-4 Isostearate Pentylene Glycol Cetyl Peg/ppg-10/1 Dimethicone (hlb 1.5) Hexyl Laurate Magnesium Sulfate, Unspecified Form Disteardimonium Hectorite Trihydroxystearin Carboxymethylcellulose Sodium, Unspecified Form Aluminum Hydroxide Disodium Stearoyl Glutamate Acetylated Glycol Stearate Ethylhexylglycerin Ferric Oxide Red

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-01-01

Description

Titanium dioxide 6.8%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium dioxide 6.8%

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

Warnings

For external use only

Directions

For sunscreen use:

● apply liberally 15 minutes before sun exposure

● reapply at least every 2 hours

● use a water resistant sunscreen if swimming or sweating

● 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

● children under 6 months of age: Ask a doctor

Do Not Use

on damaged or broken skin

Active Ingredient

Titanium dioxide 6.8%

Other Information

protect the product in this container from excessive heat and direct sun

Inactive Ingredients

water, undecane, dimethicone, glycerin, tridecane, polyglyceryl-4 isostearate, pentylene glycol, cetyl PEG/PPG-10/1, hexyl laurate, magnesium sulfate, disteardimonium hectorite, trihydroxystearin, cellulose gum, aluminum hydroxide, disodium stearoyl glutamate, acetylated glycol stearate, acrylates copolymer, ethylhexylglyceerin; may contain: titanium dioxide, iron oxides

Questions Or Comments?

1-877-900-6700

Monday - Friday (9 a.m. - 5 p.m. EST)

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 swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

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

Sunscreen

Warnings

For external use only

Directions

For sunscreen use:

● apply liberally 15 minutes before sun exposure

● reapply at least every 2 hours

● use a water resistant sunscreen if swimming or sweating

● 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

● children under 6 months of age: Ask a doctor

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredient (Active ingredient)

Titanium dioxide 6.8%

Other Information (Other information)

protect the product in this container from excessive heat and direct sun

Inactive Ingredients (Inactive ingredients)

water, undecane, dimethicone, glycerin, tridecane, polyglyceryl-4 isostearate, pentylene glycol, cetyl PEG/PPG-10/1, hexyl laurate, magnesium sulfate, disteardimonium hectorite, trihydroxystearin, cellulose gum, aluminum hydroxide, disodium stearoyl glutamate, acetylated glycol stearate, acrylates copolymer, ethylhexylglyceerin; may contain: titanium dioxide, iron oxides

Questions Or Comments? (Questions or comments?)

1-877-900-6700

Monday - Friday (9 a.m. - 5 p.m. EST)

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rash occurs

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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