Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 4f4a8c37-af08-4bf7-89bc-1e487417c146
Route
TOPICAL
Published
Effective Date 2023-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (30 mg)
Inactive Ingredients
Water Glycerin Caprylyl Trisiloxane Propanediol Dimethicone Rosa Gallica Flower Sorbitol Sodium Chloride Sodium Citrate Hyaluronate Sodium Moringa Oleifera Leaf Aluminum Oxide Edetate Disodium Sodium Phosphate, Dibasic, Anhydrous Isopropyl Titanium Triisostearate Propylene Glycol Dipropylene Glycol Citric Acid Monohydrate Butylated Hydroxytoluene Tocopherol Phenoxyethanol Chlorphenesin Titanium Dioxide Ferric Oxide Red

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-11-01 Until 2020-11-01

Description

Octinoxate 3%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octinoxate 3%

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 liberally 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

Active Ingredient

Octinoxate 3%

Other Information

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

Flammable Until Dry.

Do not use near fire, flame or heat.

Inactive Ingredients

water, glycerin, caprylyl methicone, propanediol, dimethicone, rosa gallica flower exract, sorbitol, triethoxysilylethyl polydimethylsiloxyethyl dimethicone, dimethicone/PEG-10/15 crosspolymer, sodium chloride, sodium citrate, sodium hyaluronate, morninga oleifera seed extract, alumina, disodium EDTA, disodium phosphate, isopropyl titanium triisostearate, propylene glycol, diproplylene glycol, citric acid, BHT, tocopherol, phenoxyethanol, chlorphenesin, fragrance; may contain: titanium dioxide, iron oxides

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 liberally 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

Active Ingredient (Active ingredient)

Octinoxate 3%

Other Information (Other information)

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

Flammable Until Dry. (Flammable until dry.)

Do not use near fire, flame or heat.

Inactive Ingredients (Inactive ingredients)

water, glycerin, caprylyl methicone, propanediol, dimethicone, rosa gallica flower exract, sorbitol, triethoxysilylethyl polydimethylsiloxyethyl dimethicone, dimethicone/PEG-10/15 crosspolymer, sodium chloride, sodium citrate, sodium hyaluronate, morninga oleifera seed extract, alumina, disodium EDTA, disodium phosphate, isopropyl titanium triisostearate, propylene glycol, diproplylene glycol, citric acid, BHT, tocopherol, phenoxyethanol, chlorphenesin, fragrance; may contain: titanium dioxide, iron oxides

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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