Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 511f6de9-264a-4cf2-97c3-aa8adbc52a87
Route
TOPICAL
Published
Effective Date 2023-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (150 mg) Octisalate (50 mg) Octocrylene (10 mg)
Inactive Ingredients
Water Polymethylsilsesquioxane (4.5 Microns) Glycerin Dimethicone Styrene/acrylamide Copolymer (500000 Mw) Silicon Dioxide Caprylyl Trisiloxane Diethylhexyl Syringylidenemalonate Peg-100 Stearate Glyceryl Monostearate Phenoxyethanol Potassium Cetyl Phosphate Tocopherol Caprylyl Glycol Panthenol Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Trolamine Peg-8 Laurate Chlorphenesin P-anisic Acid Medium-chain Triglycerides Xanthan Gum Edetate Disodium Senna Alata Leaf Maltodextrin Sodium Dodecylbenzenesulfonate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-06-01

Description

Avobenzone 3% Homosalate 15% Octisalate 5% Octocrylene 10%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 15% Octisalate 5% Octocrylene 10%

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:

● 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

Do Not Use

on damaged or broken skin

Other Information

protect the product in this container from excessive heat and direct sun

Active Ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

Inactive Ingredients

water, polymethylsilsesquioxane, glycerin, dimethicone, poly c10-30 alkyl acrylate, styrene/acrylates copolymer, silica, caprylyl methicone, acrylates/dimethicone copolymer, diethylhexyl syringylidenemalonate, PEG-100 stearate, glyceryl stearate, phenoxyethanol, potassium cetyl phosphate, tocopherol, caprylyl glycol, panthenol, acrylates/c10-30 alkyl acrylate crosspolymer, triethanolamine, PEG-8 laurate, inulin lauryl carbamate, chlorphenesin, p-anisic acid, caprylic/capric triglyceride, xanthan gum, disodium EDTA, cassia alata leaf extract, maltodextrine, sodium dodecylbenzenesulfonate

Questions Or Comments?

1-888-LRP-LAB0 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:

● 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

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

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

Inactive Ingredients (Inactive ingredients)

water, polymethylsilsesquioxane, glycerin, dimethicone, poly c10-30 alkyl acrylate, styrene/acrylates copolymer, silica, caprylyl methicone, acrylates/dimethicone copolymer, diethylhexyl syringylidenemalonate, PEG-100 stearate, glyceryl stearate, phenoxyethanol, potassium cetyl phosphate, tocopherol, caprylyl glycol, panthenol, acrylates/c10-30 alkyl acrylate crosspolymer, triethanolamine, PEG-8 laurate, inulin lauryl carbamate, chlorphenesin, p-anisic acid, caprylic/capric triglyceride, xanthan gum, disodium EDTA, cassia alata leaf extract, maltodextrine, sodium dodecylbenzenesulfonate

Questions Or Comments? (Questions or comments?)

1-888-LRP-LAB0 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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