drug facts

drug facts
SPL v7
SPL
SPL Set ID bf0e22df-4043-407f-a930-29595da1bdf6
Route
topical
Published
Effective Date 2023-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (30 mg) homosalate (50 mg) octisalate (70 mg) octocrylene
Inactive Ingredients
water glycerin dimethicone silicon dioxide peg-100 stearate glyceryl monostearate glycolic acid guanosine cyathea medullaris leaf tert-butyl alcohol dicaprylyl carbonate mica tocopherol ascorbyl glucoside sodium hydroxide hyaluronate sodium sodium benzoate sodium levulinate stearic acid phenoxyethanol steareth-100 phenylethyl resorcinol palmitic acid dimethicone/vinyl dimethicone crosspolymer (hard particle) limonene, (+)- xanthan gum pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) benzyl alcohol stannic oxide cinnamic acid leontopodium nivale subsp. alpinum root caprylyl glycol myristic acid geraniol edetate disodium titanium dioxide vitamin a palmitate citric acid monohydrate potassium sorbate levulinic acid glyceryl caprylate

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2017-09-01 Until 2017-09-01

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 5% Octisalate 5% Octocrylene 7%


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 of 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, glycerin, dimethicone, silica, PEG-100 stearate, glyceryl stearate, glycolic acid, guanosine, cyathea medullaris leaf extract, t-butyl alcohol, dicaprylyl carbonate, mica, tocopherol, ascorbyl glycoside, sodium hydroxide, sodium hyaluronate, hydrolyzed linseed extract, sodium benzoate, sodium levulinate, stearic acid, phenoxyethanol, steareth-100, phenylethyl resorcinol, palmitic acid, ammonium polyacryloyldimethyl taurate, dimethicone/vinyl dimethicone crosspolymer, limonene, xanthan gum, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, benzyl alcohol, tin oxide, cinnamic acid, leontopodium alpinum extract, caprylyl glycol, myristic acid, geraniol, disodium EDTA, titanium dioxide, retinyl palmitate, citric acid, potassium sorbate, levulinic acid, glyceryl pacrylate, fragrance

Description

Avobenzone 3% Homosalate 5% Octisalate 5% Octocrylene 7%

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredients

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Octocrylene 7%

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

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 of 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, glycerin, dimethicone, silica, PEG-100 stearate, glyceryl stearate, glycolic acid, guanosine, cyathea medullaris leaf extract, t-butyl alcohol, dicaprylyl carbonate, mica, tocopherol, ascorbyl glycoside, sodium hydroxide, sodium hyaluronate, hydrolyzed linseed extract, sodium benzoate, sodium levulinate, stearic acid, phenoxyethanol, steareth-100, phenylethyl resorcinol, palmitic acid, ammonium polyacryloyldimethyl taurate, dimethicone/vinyl dimethicone crosspolymer, limonene, xanthan gum, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, benzyl alcohol, tin oxide, cinnamic acid, leontopodium alpinum extract, caprylyl glycol, myristic acid, geraniol, disodium EDTA, titanium dioxide, retinyl palmitate, citric acid, potassium sorbate, levulinic acid, glyceryl pacrylate, fragrance

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Octocrylene 7%

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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