drug facts

drug facts
SPL v3
SPL
SPL Set ID 4692b146-1abe-48e8-b097-ea9c556962b6
Route
topical
Published
Effective Date 2023-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (148 mg)
Inactive Ingredients
water isododecane dimethicone alkyl (c12-15) benzoate undecane styrene/acrylamide copolymer (500000 mw) caprylyl trisiloxane nylon-12 butyloctyl salicylate phenethyl benzoate dicaprylyl carbonate silicon dioxide triethylhexanoin isohexadecane tridecane dicaprylyl ether talc dimethicone/peg-10/15 crosspolymer aluminum hydroxide stearic acid peg-9 polydimethylsiloxyethyl dimethicone pentylene glycol aluminum oxide aluminum stearate benzoic acid benzyl benzoate caprylyl glycol ferric oxide red dipropylene glycol disodium stearoyl glutamate disteardimonium hectorite magnesium sulfate, unspecified form peg-8 laurate phenoxyethanol polyhydroxystearic acid (2300 mw) propylene carbonate sodium citrate sodium dodecylbenzenesulfonate tocopherol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-12-01

Purpose

Sunscreen

Description

Titanium dioxide 14.8%


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

For sunscreen use:

  • shake well before use

●  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
  • store at 68 – 77° F (20 – 25°C)
Inactive Ingredients

water, isododecane, dimethicone, c12-15 alkyl benzoate, undecane, styrene/acrylates copolymer, caprylyl methicone, nylon-12, butyloctyl salicylate, phenethyl benzoate, dicaprylyl carbonate, silica, triethylhexanoin, isohexadecane, tridecane, dicaprylyl ether, talc, dimethicone/PEG-10/15 crosspolymer, aluminum hydroxide, stearic acid, PEG-9 polydimethylsiloxyethyl dimethicone, pentylene glycol, alumina, aluminum stearate, benzoic acid, benzyl benzoate, caprylyl glycol, iron oxides, dipropylene glycol, disodium stearoyl glutamate, disteardimonium hectorite, helianthus annuus seed oil/sunflower seed oil, magnesium sulfate, PEG-8 laurate, phenoxyethanol, polyhydroxystearic acid, propylene carbonate, sodium citrate, sodium dodecylbenzenesulfonate, tocopherol

Description

Titanium dioxide 14.8%

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredients

Titanium dioxide 14.8%

Questions Or Comments?

Call toll free 1-877-378-4249

Monday - Friday (9 a.m. to 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

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

For sunscreen use:

  • shake well before use

●  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
  • store at 68 – 77° F (20 – 25°C)
Inactive Ingredients (Inactive ingredients)

water, isododecane, dimethicone, c12-15 alkyl benzoate, undecane, styrene/acrylates copolymer, caprylyl methicone, nylon-12, butyloctyl salicylate, phenethyl benzoate, dicaprylyl carbonate, silica, triethylhexanoin, isohexadecane, tridecane, dicaprylyl ether, talc, dimethicone/PEG-10/15 crosspolymer, aluminum hydroxide, stearic acid, PEG-9 polydimethylsiloxyethyl dimethicone, pentylene glycol, alumina, aluminum stearate, benzoic acid, benzyl benzoate, caprylyl glycol, iron oxides, dipropylene glycol, disodium stearoyl glutamate, disteardimonium hectorite, helianthus annuus seed oil/sunflower seed oil, magnesium sulfate, PEG-8 laurate, phenoxyethanol, polyhydroxystearic acid, propylene carbonate, sodium citrate, sodium dodecylbenzenesulfonate, tocopherol

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients (Active ingredients)

Titanium dioxide 14.8%

Questions Or Comments? (Questions or comments?)

Call toll free 1-877-378-4249

Monday - Friday (9 a.m. to 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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