drug facts

drug facts
SPL v6
SPL
SPL Set ID 451e50a2-2dd7-4c90-88c9-b9f9056d7ee3
Route
topical
Published
Effective Date 2024-06-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (30 mg) homosalate (150 mg) octisalate (50 mg) octocrylene (70 mg)
Inactive Ingredients
water alcohol styrene/acrylamide copolymer (500000 mw) dimethicone 2-ethylhexyl acrylate, methacrylate, methyl methacrylate, or butyl methacrylate/hydroxypropyl dimethicone copolymer (30000-300000 mw) tocopherol dicaprylyl ether sodium polyacrylate (2500000 mw) sodium dodecylbenzenesulfonate sodium benzoate diethylhexyl syringylidenemalonate phenoxyethanol peg-8 laurate trisodium ethylenediamine disuccinate menthyl lactate, (-)- pentylene glycol mentha x piperita whole xanthan gum propanediol leontopodium nivale subsp. alpinum flowering top caprylyl glycol medium-chain triglycerides carbomer interpolymer type a (allyl sucrose crosslinked) moringa oleifera leaf sodium phosphate, dibasic, anhydrous butylene glycol citric acid monohydrate potassium sorbate glycerin

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-12-22 Until 2027-03-11

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 15% 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 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, alcohol denat., styrene/acrylates copolymer, dimethicone, acrylates/dimethicone copolymer, tocopherol, dicaprylyl ether, sodium polyacrylate, sodium dodecylbenzenesulfonate, sodium benzoate, diethylhexyl syringylidenemalonate, phenoxyethanol, PEG-8 laurate, trisodium ethylenediamine disuccinate, menthyl lactate, pentylene glycol, mentha piperita (peppermint) extract, xanthan gum, propanediol, leontopodium alpinum flower/leaf extract, caprylyl glycol, caprylic/capric triglyceride, acrylates/c10-30 alkyl acrylate crosspolymer, moringa oleifera seed extract, rosa meichibon/delgramaue callus, disodium phosphate, butylene glycol, citric acid, potassium sorbate, glycerin, fragrance

Description

Avobenzone 3% Homosalate 15% Octisalate 5% Octocrylene 7%

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 7%

Flammable Until Dry.

Do not use near fire, flame, or heat.

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 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, alcohol denat., styrene/acrylates copolymer, dimethicone, acrylates/dimethicone copolymer, tocopherol, dicaprylyl ether, sodium polyacrylate, sodium dodecylbenzenesulfonate, sodium benzoate, diethylhexyl syringylidenemalonate, phenoxyethanol, PEG-8 laurate, trisodium ethylenediamine disuccinate, menthyl lactate, pentylene glycol, mentha piperita (peppermint) extract, xanthan gum, propanediol, leontopodium alpinum flower/leaf extract, caprylyl glycol, caprylic/capric triglyceride, acrylates/c10-30 alkyl acrylate crosspolymer, moringa oleifera seed extract, rosa meichibon/delgramaue callus, disodium phosphate, butylene glycol, citric acid, potassium sorbate, glycerin, fragrance

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 7%

Flammable Until Dry. (Flammable until dry.)

Do not use near fire, flame, or heat.

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.


Advanced Ingredient Data


Raw Label Data

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