Drug Facts

Drug Facts
SPL v9
SPL
SPL Set ID 30cb2f12-1ebe-4850-be16-17748f0ba670
Route
TOPICAL
Published
Effective Date 2023-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (20 mg) Octisalate (50 mg) Octocrylene (100 mg)
Inactive Ingredients
Water Glycerin Alcohol Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2004-01-01 Until 2004-01-01

Description

Avobenzone 2% Octisalate 5% Octocrylene 10%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2% 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:

● shake well

● apply generously and evenly 15minutes 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 10%

Inactive Ingredients

water, glycerin, alcohol denat., glyceryl stearate, theobroma cacao (cocoa) seed butter, squalane, silica, PEG-100 stearate, glycol distearate, oryza sativa (rice) bran oil, butylene glycol, tocopheryl acetate, lactic acid, vaccinium myrtillus fruit extract, saccharum officinarum (sugar cane) extact, padina pavonica extract, stearic acid, pehnoxyethanol, acer saccharum (sugar maple) extract, palmitic acid, chlorphenesin, polysorbate 80, chlorhexidine digluconate, dimethicone, ammonium polyacryloyldimethyl taurate, dimethiconol, limonene, xanthan gum, linalool, ginkgo biloba leaf extract, dioscorea villosa (wild yam) root extract, propylene glycol, isohexadecane, iron oxides, paraffin, acrylamide/sodium acryloyldimethyltaurate copolymer, rosa centifolia flower extract, tetrasodium EDTA, citrus aurantium dulcis (orange) fruit water, citrus limon (lemon) fruit extract, citronellol, citral, hexyldecanol, glycine soja (soybean) protein, glycyrrhiza glabra (licorice) root extrract, fragrance, sodium benzoate

Questions Or Comments?

1-800-LANCOME (1-800-526-2663)

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:

● shake well

● apply generously and evenly 15minutes 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 2%

Octisalate 5%

Octocrylene 10%

Inactive Ingredients (Inactive ingredients)

water, glycerin, alcohol denat., glyceryl stearate, theobroma cacao (cocoa) seed butter, squalane, silica, PEG-100 stearate, glycol distearate, oryza sativa (rice) bran oil, butylene glycol, tocopheryl acetate, lactic acid, vaccinium myrtillus fruit extract, saccharum officinarum (sugar cane) extact, padina pavonica extract, stearic acid, pehnoxyethanol, acer saccharum (sugar maple) extract, palmitic acid, chlorphenesin, polysorbate 80, chlorhexidine digluconate, dimethicone, ammonium polyacryloyldimethyl taurate, dimethiconol, limonene, xanthan gum, linalool, ginkgo biloba leaf extract, dioscorea villosa (wild yam) root extract, propylene glycol, isohexadecane, iron oxides, paraffin, acrylamide/sodium acryloyldimethyltaurate copolymer, rosa centifolia flower extract, tetrasodium EDTA, citrus aurantium dulcis (orange) fruit water, citrus limon (lemon) fruit extract, citronellol, citral, hexyldecanol, glycine soja (soybean) protein, glycyrrhiza glabra (licorice) root extrract, fragrance, sodium benzoate

Questions Or Comments? (Questions or comments?)

1-800-LANCOME (1-800-526-2663)

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.


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