drug facts

drug facts
SPL v8
SPL
SPL Set ID 6b65d6d9-7ff3-4c84-986e-ef180161eadb
Route
topical
Published
Effective Date 2023-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (30 mg) homosalate (100 mg) octisalate (50 mg) octocrylene (60 mg) oxybenzone
Inactive Ingredients
dimethicone alkyl (c12-15) benzoate talc diisopropyl sebacate silicon dioxide glycerin trimethylsiloxysilicate (m/q 0.6-0.8) dimethicone crosspolymer (450000 mpa.s at 12% in cyclopentasiloxane) water diethylhexyl syringylidenemalonate senna alata leaf maltodextrin

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2012-04-05

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 5% Oxybenzone 6%


Medication Information

Warnings

For external use only

Uses
  • helps prevent sunburn
  • if used as directed (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
Purpose

Sunscreen

Directions

For sunscreen use:

  • apply generously 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 of 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, talc, diisopropyl sebacate, silica, silica silylate, glycerin, trimethylsiloxysilicate, dimethicone crosspolymer, water, diethylhexyl syringylidenemalonate, cassia alata leaf extract, maltodextrin

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 5% Oxybenzone 6%

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 5%

Oxybenzone 6%

Questions Or Comments?

1-888-LRP-LABO  1-888-577-5226

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

Warnings

For external use only

Uses
  • helps prevent sunburn
  • if used as directed (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
Purpose

Sunscreen

Directions

For sunscreen use:

  • apply generously 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 of 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, talc, diisopropyl sebacate, silica, silica silylate, glycerin, trimethylsiloxysilicate, dimethicone crosspolymer, water, diethylhexyl syringylidenemalonate, cassia alata leaf extract, maltodextrin

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 5%

Oxybenzone 6%

Questions Or Comments? (Questions or comments?)

1-888-LRP-LABO  1-888-577-5226

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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