drug facts

drug facts
SPL v9
SPL
SPL Set ID f296e5ef-728a-4d57-8d65-7d88b1f90f88
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 (70 mg)
Inactive Ingredients
water alkyl (c12-15) benzoate propylene glycol diisopropyl sebacate glycerin alcohol dimethicone potassium cetyl phosphate butyl acrylate/methyl methacrylate/methacrylic acid copolymer (18000 mw) ammonium polyacryloyldimethyl taurate (55000 mpa.s) medium-chain triglycerides caprylyl glycol diethylhexyl syringylidenemalonate edetate disodium glyceryl monostearate hypromellose, unspecified isopropyl lauroyl sarcosinate myristic acid palmitic acid peg-100 stearate peg-8 laurate pentylene glycol phenoxyethanol sodium chloride stearic acid tert-butyl alcohol tocopherol trolamine

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2016-11-01

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 7%


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:

●  apply generously 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

water, C12-15 alkyl benzoate, propylene glycol, diisopropyl sebacate, styrene/acrylates copolymer, glycerin, alcohol denat., dimethicone, potassium cetyl phosphate, acrylates copolymer, ammonium polyacryloyldimethyl taurate, caprylic/capric triglyceride, caprylyl glycol, diethylhexyl syringylidenemalonate, disodium EDTA, glyceryl stearate, hydroxypropyl methylcellulose, isopropyl lauroyl sarcosinate, myristic acid, palmitic acid, PEG-100 stearate, PEG-8 laurate, pentylene glycol, phenoxyethanol, sodium chloride, stearic acid, t-butyl alcohol, tocopherol, triethanolamine

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 7%

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredient

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 7%

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 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:

●  apply generously 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)

water, C12-15 alkyl benzoate, propylene glycol, diisopropyl sebacate, styrene/acrylates copolymer, glycerin, alcohol denat., dimethicone, potassium cetyl phosphate, acrylates copolymer, ammonium polyacryloyldimethyl taurate, caprylic/capric triglyceride, caprylyl glycol, diethylhexyl syringylidenemalonate, disodium EDTA, glyceryl stearate, hydroxypropyl methylcellulose, isopropyl lauroyl sarcosinate, myristic acid, palmitic acid, PEG-100 stearate, PEG-8 laurate, pentylene glycol, phenoxyethanol, sodium chloride, stearic acid, t-butyl alcohol, tocopherol, triethanolamine

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredient (Active ingredient)

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 7%

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

All Sections (JSON)