Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID 3a6db7d3-6c59-4633-a97e-1c03127246d3
Route
TOPICAL
Published
Effective Date 2024-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (50 mg) Zinc Oxide (40 mg)
Inactive Ingredients
Water Glycerin Alkyl (c12-15) Benzoate Dimethicone Butyloctyl Salicylate Phenethyl Benzoate Triethylhexanoin Isohexadecane Styrene/acrylamide Copolymer (500000 Mw) Stearyl Trisiloxane Shea Butter Isododecane Polyglyceryl-4 Isostearate Talc Nylon-12 Pentylene Glycol Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone Aluminum Stearate Phenoxyethanol Aluminum Oxide Polyhydroxystearic Acid (2300 Mw) Magnesium Sulfate, Unspecified Form Caprylyl Glycol Peg-8 Laurate Disteardimonium Hectorite Triethoxycaprylylsilane Tocopherol Propylene Carbonate Arnica Montana Benzoic Acid Dipropylene Glycol Hyaluronate Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-01-01

Description

Titanium dioxide 5% Zinc oxide 4%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium dioxide 5% Zinc oxide 4%

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

● shake well before 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

Other Information

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

Active Ingredients

Titanium dioxide 5%

Zinc oxide 4%

Inactive Ingredients

water, glycerin, c12-15 alkyl benzoate, dimethicone, butyloctyl salicylate, phenethyl benzoate, triethylhexanoin, isohexadecane, styrene/acrylates copolymer, stearyl dimethicone, butyrospermum parkii (shea) butter, isododecane, polyglyceryl-4 isostearate, talc, dimethicone/polyglycerin-3 crosspolymer, nylon-12, pentylene glycol, lauryl PEG-9 polydimethylsiloxyethyl dimethicone, aluminum stearate, phenoxyethanol, alumina, polyhydroxystearic acid, magnesium sulfate, caprylyl glycol, PEG-8 laurate, disteardimonium hectorite, triethoxycaprylylsilane, tocopherol, propylene carbonate, artemia extract, benzoic acid, dipropylene glycol, sodium hyaluronate

Questions Or Comments?

Call 1-800-811-1660

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

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

● shake well before 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

Other Information (Other information)

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

Active Ingredients (Active ingredients)

Titanium dioxide 5%

Zinc oxide 4%

Inactive Ingredients (Inactive ingredients)

water, glycerin, c12-15 alkyl benzoate, dimethicone, butyloctyl salicylate, phenethyl benzoate, triethylhexanoin, isohexadecane, styrene/acrylates copolymer, stearyl dimethicone, butyrospermum parkii (shea) butter, isododecane, polyglyceryl-4 isostearate, talc, dimethicone/polyglycerin-3 crosspolymer, nylon-12, pentylene glycol, lauryl PEG-9 polydimethylsiloxyethyl dimethicone, aluminum stearate, phenoxyethanol, alumina, polyhydroxystearic acid, magnesium sulfate, caprylyl glycol, PEG-8 laurate, disteardimonium hectorite, triethoxycaprylylsilane, tocopherol, propylene carbonate, artemia extract, benzoic acid, dipropylene glycol, sodium hyaluronate

Questions Or Comments? (Questions or comments?)

Call 1-800-811-1660

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

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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