Drug Facts

Drug Facts
SPL v12
SPL
SPL Set ID 08645f1d-7ba7-4410-8600-3d3f79d71385
Route
TOPICAL
Published
Effective Date 2023-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (20 mg) Octisalate (50 mg) Octocrylene (80 mg)
Inactive Ingredients
Water Alcohol Glyceryl Stearate Se

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-06-01

Description

Avobenzone 2% Octisalate 5% Octocrylene 8%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2% Octisalate 5% Octocrylene 8%

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 and evenly 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 2%

Octisalate 5%

Octocrylene 8%

Inactive Ingredients

water, hydrogenated polyisobutene, alcohol denat., bis-PEG-18 methyl ether dimethyl silane, glycerin, cyclohexasiloxane, cetearyl alcohol, dimethicone, PEG-20, prunus armeniaca (apricot) kernel oil, petrolatum, C13-14 isoparaffin, tocopheryl acetate, hydroxypropyl tetrahydropyrantriol, hydrolyzed malt extract, sodium hyaluronate, padina pavonica extract, sodium hydroxide, hydrolyzed soy protein, adenosine, PEG-100 stearate, polyacrylamide, calcium pantothenate, dimethyl isosorbide, dimethiconol, limonene, xanthan gum, linalool, dioscorea villosa (wild yam) root extract, iron oxides, caprylyl glycol, capryloyl salicylic acid, paraffin, acrylates/C10-30 alkyl acrylate, crosspolymer, disodium EDTA, butyrospermum parkii (shea butter), butylene glycol, cetyl alcohol, cetearyl glucoside, octyldodecanol, citronellol, laureth-7, hexyldecanol, glyceryl stearate, fragrance

Questions Or Comments?

1-800-LANCOME (1-800-526-2663) Monday - Friday (9 am - 5 pm 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 and evenly 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

Avobenzone 2%

Octisalate 5%

Octocrylene 8%

Inactive Ingredients (Inactive ingredients)

water, hydrogenated polyisobutene, alcohol denat., bis-PEG-18 methyl ether dimethyl silane, glycerin, cyclohexasiloxane, cetearyl alcohol, dimethicone, PEG-20, prunus armeniaca (apricot) kernel oil, petrolatum, C13-14 isoparaffin, tocopheryl acetate, hydroxypropyl tetrahydropyrantriol, hydrolyzed malt extract, sodium hyaluronate, padina pavonica extract, sodium hydroxide, hydrolyzed soy protein, adenosine, PEG-100 stearate, polyacrylamide, calcium pantothenate, dimethyl isosorbide, dimethiconol, limonene, xanthan gum, linalool, dioscorea villosa (wild yam) root extract, iron oxides, caprylyl glycol, capryloyl salicylic acid, paraffin, acrylates/C10-30 alkyl acrylate, crosspolymer, disodium EDTA, butyrospermum parkii (shea butter), butylene glycol, cetyl alcohol, cetearyl glucoside, octyldodecanol, citronellol, laureth-7, hexyldecanol, glyceryl stearate, fragrance

Questions Or Comments? (Questions or comments?)

1-800-LANCOME (1-800-526-2663) Monday - Friday (9 am - 5 pm 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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