Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID d60887aa-7586-4d4b-88af-35b4f982aacf
Route
TOPICAL
Published
Effective Date 2023-10-18
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 C15-19 Alkane Niacinamide Glycerin Butylene Glycol Silicon Dioxide Titanium Dioxide Shea Butter Stannic Oxide Potassium Hydroxide Carbomer Homopolymer, Unspecified Type Arachidyl Alcohol Arachidyl Glucoside Docosanol Sodium Dilauramidoglutamide Lysine Sodium Thiosulfate Ammonium Acryloyldimethyltaurate/vp Copolymer Hydroxyacetophenone Capryloyl Salicylic Acid Caprylyl Glycol Citric Acid Monohydrate Trisodium Ethylenediamine Disuccinate Xanthan Gum Pentylene Glycol Behenyl Acrylate Polymer Polyglyceryl-4 Caprate Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Phenoxyethanol Fd&c Red No. 4 Mica

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-15

Description

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

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

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

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

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 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
  • store at 20º - 25º C (68º - 77º F)
Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 7%

Inactive Ingredients

water, c15-19 alkane, niacinamide, glycerin, butylene glycol, silica, titanium dioxide, butyrospermum parkii (shea) butter, tin oxide, potassium hydroxide, carbomer, arachidyl alcohol, arachidyl glucoside, behenyl alcohol, 2-mercaptonicotinoyl glycine, sodium dilauramidoglutamide lysine, sodium thiosulfate, ammonium acryloyldimethyltaurate/VP copolymer, hydroxyacetophenone, capryloyl salicylic acid, caprylyl glycol, citric acid, trisodium ethylenediamine disuccinate, xanthan gum, pentylene glycol, poly c10-30 alkyl acrylate, polyglyceryl-4 caprate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, red 4, mica, fragrance

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

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

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 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
  • store at 20º - 25º C (68º - 77º F)
Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 7%

Inactive Ingredients (Inactive ingredients)

water, c15-19 alkane, niacinamide, glycerin, butylene glycol, silica, titanium dioxide, butyrospermum parkii (shea) butter, tin oxide, potassium hydroxide, carbomer, arachidyl alcohol, arachidyl glucoside, behenyl alcohol, 2-mercaptonicotinoyl glycine, sodium dilauramidoglutamide lysine, sodium thiosulfate, ammonium acryloyldimethyltaurate/VP copolymer, hydroxyacetophenone, capryloyl salicylic acid, caprylyl glycol, citric acid, trisodium ethylenediamine disuccinate, xanthan gum, pentylene glycol, poly c10-30 alkyl acrylate, polyglyceryl-4 caprate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, red 4, mica, fragrance

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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