Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 8e294a61-97e2-4df8-8a59-7cec12c6f016
Route
TOPICAL
Published
Effective Date 2023-12-29
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 Glycerin Alcohol Hydrogenated Polybutene (1300 Mw) Bis-peg-18 Methyl Ether Dimethyl Silane Dimethicone Cetostearyl Alcohol Peg-100 Stearate Polyethylene Glycol 1000 Petrolatum Shea Butter C13-14 Isoparaffin Glyceryl Monostearate Dimethiconol (70 Cst) Dimethyl Isosorbide Cetearyl Glucoside Neohesperidin Dihydrochalone Sodium Cocoyl Glutamate Hyaluronate Sodium Sodium Hydroxide Cyclodextrins Adenosine Moth Bean Mannitol Edetate Disodium Sodium Succinate Anhydrous Capryloyl Salicylic Acid Laureth-7 Yeast, Unspecified Xanthan Gum Polyacrylamide (10000 Mw) Cetyl Alcohol Octyldodecanol .alpha.-tocopherol Acetate Sodium Dehydroacetate Phenoxyethanol Fd&c Red No. 4 Fd&c Yellow No. 5 Linalool, (+/-)- Geraniol Limonene, (+)- Hydroxycitronellal Benzyl Alcohol Benzyl Salicylate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2021-02-09 Until 2021-02-09

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 liberally 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

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 7%

Inactive Ingredients

water, glycerin, alcohol denat., hydrogenated polyisobutene, bis-PEG-18 methyl ether dimethyl silane, dimethicone, cetearyl alcohol, PEG-100 stearate, PEG-20, petrolatum, butyrospermum parkii (shea) butter, C13-14 isoparaffin, glyceryl stearate, dimethiconol, dimethyl isosorbide, cetearyl glucoside, neohesperidin dihydrochalcone, sodium cocoyl glutamate, sodium hyaluronate, sodium hydroxide, cyclodextrin, adenosine, vigna aconitifolia seed extract, mannitol, disodium EDTA, disodium succinate, hydrolyzed cicer seed extract, capryloyl salicylic acid, laureth-7, yeast extract, xanthan gum, polyacrylamide, acrylates/C10-30 alkyl acrylate crosspolymer, cetyl alcohol, octyldodecanol, tocopheryl acetate, sodium dehydroacetate, phenoxyethanol, red 4, yellow 5, linalool, geraniol, alpha-isomethyl ionone, limonene, hydroxycitronellal, cironellol, hexyl cinnamal, benzyl alcohol, benzyl salicylate, fragrance

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 liberally 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

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 7%

Inactive Ingredients (Inactive ingredients)

water, glycerin, alcohol denat., hydrogenated polyisobutene, bis-PEG-18 methyl ether dimethyl silane, dimethicone, cetearyl alcohol, PEG-100 stearate, PEG-20, petrolatum, butyrospermum parkii (shea) butter, C13-14 isoparaffin, glyceryl stearate, dimethiconol, dimethyl isosorbide, cetearyl glucoside, neohesperidin dihydrochalcone, sodium cocoyl glutamate, sodium hyaluronate, sodium hydroxide, cyclodextrin, adenosine, vigna aconitifolia seed extract, mannitol, disodium EDTA, disodium succinate, hydrolyzed cicer seed extract, capryloyl salicylic acid, laureth-7, yeast extract, xanthan gum, polyacrylamide, acrylates/C10-30 alkyl acrylate crosspolymer, cetyl alcohol, octyldodecanol, tocopheryl acetate, sodium dehydroacetate, phenoxyethanol, red 4, yellow 5, linalool, geraniol, alpha-isomethyl ionone, limonene, hydroxycitronellal, cironellol, hexyl cinnamal, benzyl alcohol, benzyl salicylate, fragrance

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)