drug facts

drug facts
SPL v6
SPL
SPL Set ID b137b3d0-212b-440a-b158-62ace4b4eff3
Route
topical
Published
Effective Date 2024-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (90 mg) zinc cation (40 mg)
Inactive Ingredients
dimethicone alkyl (c12-15) benzoate talc dicaprylyl ether triethylhexanoin isohexadecane dimethicone crosspolymer (450000 mpa.s at 12% in cyclopentasiloxane) styrene/acrylamide copolymer (500000 mw) hydrogenated jojoba oil dimethicone/vinyl dimethicone crosspolymer (hard particle) aluminum stearate peg-8 laurate triethoxycaprylylsilane 2-oleamido-1,3,4-octadecatriyl prolinate aluminum oxide aluminum hydroxide ferric oxide red disodium stearoyl glutamate polyhydroxystearic acid (2300 mw)

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2015-03-01

Purpose

Sunscreen

Description

Titanium dioxide 9% Zinc oxide 4%


Medication Information

Warnings

For external use only

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

Purpose

Sunscreen

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

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

Other Information

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

Inactive Ingredients

dimethicone, C12-15 alkyl benzoate, dicaprylyl ether, dimethicone/vinyl dimethicone crosspolymer, talc, triethylhexanoin, isohexadecane, styrene/acrylates copolymer, hydrogenated jojoba oil, aluminum hydroxide, stearic acid, aluminum stearate, iron oxides, silica silylate, alumina, polyhydroxystearic acid, PEG-8 laureth, tocopherol, water, diethylhexyl syringylidenemalonate, laureth-4, disodium stearoyul glutamate, cassia alata leaf extract, maltodextrin, caprylic/capric triglyceride

Description

Titanium dioxide 9% Zinc oxide 4%

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredients

Titanium dioxide 9%

Zinc oxide 4%

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

Warnings

For external use only

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

Purpose

Sunscreen

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

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

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

dimethicone, C12-15 alkyl benzoate, dicaprylyl ether, dimethicone/vinyl dimethicone crosspolymer, talc, triethylhexanoin, isohexadecane, styrene/acrylates copolymer, hydrogenated jojoba oil, aluminum hydroxide, stearic acid, aluminum stearate, iron oxides, silica silylate, alumina, polyhydroxystearic acid, PEG-8 laureth, tocopherol, water, diethylhexyl syringylidenemalonate, laureth-4, disodium stearoyul glutamate, cassia alata leaf extract, maltodextrin, caprylic/capric triglyceride

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients (Active ingredients)

Titanium dioxide 9%

Zinc oxide 4%

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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