drug facts

drug facts
SPL v7
SPL
SPL Set ID 8a2fd46c-5767-4621-8e69-dd291f9fe5b1
Route
topical
Published
Effective Date 2024-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (30 mg) homosalate (130 mg) octisalate (50 mg) octocrylene (100 mg)
Inactive Ingredients
water dimethicone glycerin cyclomethicone 6 polymethylsilsesquioxane (4.5 microns) niacinamide silicon dioxide caprylyl trisiloxane medium-chain triglycerides caprylyl glycol chlorphenesin diethylhexyl syringylidenemalonate glyceryl distearate inulin lauryl carbamate p-anisic acid panthenol peg-100 stearate peg-8 laurate phenoxyethanol potassium cetyl phosphate sodium dodecylbenzenesulfonate hyaluronate sodium tocopherol trolamine trisodium ethylenediamine disuccinate xanthan gum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-10-01

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 13% Octisalate 5% Octocrylene 10%


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, dimethicone, glycerin, styrene/acrylates copolymer, poly c10-30 alkyl acrylate, polymethylsilsesquioxane, acrylates/dimethicone copolymer, niacinamide, silica, caprylyl methicone, acrylates/c10-30 alkyl acrylate crosspolymer, caprylic/capric triglyceride, caprylyl glycol, chlorphenesin, diethylhexyl syringylidenemalonate, glyceryl stearate, inulin lauryl carbamate, p-anisic acid, panthenol, PEG-100 stearate, PEG-8 laurate, phenoxyethanol, potassium cetyl phosphate, sodium dodecylbenzenesulfonate, sodium hyaluronate, tocopherol, triethanolamine, trisodium ethylenediamine disuccinate, xanthan gum

Description

Avobenzone 3% Homosalate 13% Octisalate 5% Octocrylene 10%

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredient

Avobenzone 3%

Homosalate 13%

Octisalate 5%

Octocrylene 10%

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, dimethicone, glycerin, styrene/acrylates copolymer, poly c10-30 alkyl acrylate, polymethylsilsesquioxane, acrylates/dimethicone copolymer, niacinamide, silica, caprylyl methicone, acrylates/c10-30 alkyl acrylate crosspolymer, caprylic/capric triglyceride, caprylyl glycol, chlorphenesin, diethylhexyl syringylidenemalonate, glyceryl stearate, inulin lauryl carbamate, p-anisic acid, panthenol, PEG-100 stearate, PEG-8 laurate, phenoxyethanol, potassium cetyl phosphate, sodium dodecylbenzenesulfonate, sodium hyaluronate, tocopherol, triethanolamine, trisodium ethylenediamine disuccinate, xanthan gum

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredient (Active ingredient)

Avobenzone 3%

Homosalate 13%

Octisalate 5%

Octocrylene 10%

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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