Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID a45fef28-5dde-48b2-b7c0-ede694f4c32b
Route
TOPICAL
Published
Effective Date 2023-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (70 mg)
Inactive Ingredients
Water Isohexadecane Dipentaerythrityl Hexacaprylate/hexacaprate Isodecyl Neopentanoate Glycerin Alcohol Peg-30 Dipolyhydroxystearate Dicaprylyl Carbonate Propanediol Paraffin Glycyrrhiza Glabra Padina Pavonica Aluminum Hydroxide Adenosine Magnesium Sulfate, Unspecified Form Edetate Disodium Disodium Stearoyl Glutamate Propylene Carbonate Propylene Glycol Hydroxypropyl Tetrahydropyrantriol Caprylyl Glycol Dioscorea Villosa Tuber Disteardimonium Hectorite Hexyldecanol .alpha.-tocopherol Acetate Phenoxyethanol Linalool, (+/-)- Limonene, (+)- .beta.-citronellol, (r)- Titanium Dioxide Ferric Oxide Red

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-01-01

Description

Octinoxate 7%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octinoxate 7%

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

Caution

Flammabile until dry. Avoid fire, flame and heat during application.

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 7%

Other Information

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

Inactive Ingredients

water, isohexadecane, dipentaerythrityl hexacaprylate/hexacaprate, isodecyl neopentanoate, glycerin, alcohol denat., PEG-30 dipolyhydroxystearate, methyl methacrylate crosspolymer, dicaprylyl carbonate, propanediol, paraffin, glycyrrhiza glabra (licorice) root extract, padina pavonica extract, aluminum hydroxide, adenosine, magnesium sulfate, disodium EDTA, disodium stearoyl glutamate, propylene carbonate, propylene glycol, hydroxypropyl tetrahydropyrantriol, caprylyl glycol, dioscorea villosa (wild yam) root extract, disteardimonium hectorite, hexyldecanol, tocopheryl acetate, phenoxyethanol, linalool, limonene, citronellol, fragrance; may conain: 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)

Caution

Flammabile until dry. Avoid fire, flame and heat during application.

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 7%

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

water, isohexadecane, dipentaerythrityl hexacaprylate/hexacaprate, isodecyl neopentanoate, glycerin, alcohol denat., PEG-30 dipolyhydroxystearate, methyl methacrylate crosspolymer, dicaprylyl carbonate, propanediol, paraffin, glycyrrhiza glabra (licorice) root extract, padina pavonica extract, aluminum hydroxide, adenosine, magnesium sulfate, disodium EDTA, disodium stearoyl glutamate, propylene carbonate, propylene glycol, hydroxypropyl tetrahydropyrantriol, caprylyl glycol, dioscorea villosa (wild yam) root extract, disteardimonium hectorite, hexyldecanol, tocopheryl acetate, phenoxyethanol, linalool, limonene, citronellol, fragrance; may conain: 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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