drug facts

drug facts
SPL v1
SPL
SPL Set ID a9b7e52c-8799-49ba-8b05-7559fe6668fe
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

Purpose

Sunscreen

Description

Avobenzone 2% Octisalate 5% Octocrylene 8%


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 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

Other Information

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

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

Description

Avobenzone 2% Octisalate 5% Octocrylene 8%

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredients

Avobenzone 2%

Octisalate 5%

Octocrylene 8%

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

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 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

Other Information (Other information)

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

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

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients

Avobenzone 2%

Octisalate 5%

Octocrylene 8%

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

All Sections (JSON)