Drug Facts

Manufacturer
L'Oreal USA Products Inc | L'Oreal USA, Inc.
Effective date
2023-12-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:05:55

Key Label Information#

Active Ingredients And Purpose

Active ingredient

Octinoxate 7.5%

Purpose

Sunscreen

Uses

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

Warnings

Warnings

For external use only

Do not use

on damaged or broken skin

Stop use and ask a doctor if

rash occurs

Directions And Dosage

Directions

For sunscreen use: ● 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

Other Label Information

Other information

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

Questions or comments?

1-800-322-2036 Monday - Friday (9 a.m. - 5 p.m. EST)

Inactive ingredients

cyclopentasiloxane, water, dimethicone crosspolymer, glycerin, isotridecyl isononanoate, PEG-9 polydimethylsiloxyethyl dimethicone, disteardimonium hectorite, phenoxyethanol, PEG-10 dimethicone, hydrolyzed wheat protein/PVP crosspolymer, disodium stearoyl glutamate, chlorphenesin, methylparaben, lycium barbarum fruit extract, acrylates copolymer, potassium sorbate, ethylparaben, tocopherol, ascorbyl palmitate, panthenol, PEG-9, aluminum hydroxide, citric acid, sodium PCA, urea, trehalose, polyquaternium-51, soluble collagen, sodium hyaluronate; may contain: iron oxides, titanium dioxide, mica

Label Images#

MayIARE
MayIARE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-007-01Maybelline New York Instant Age Rewind Eraser Treatment Makeup Broad Spectrum SPF 18 Sunscreen20 mL in 1 BOTTLELOTION203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-007MAYBELLINE NEW YORK INSTANT AGE REWIND ERASER TREATMENT MAKEUP BROAD SPECTRUM SPF 18 SUNSCREEN (OCTINOXATE) LOTION [L'OREAL USA PRODUCTS INC]3Current NDC, Legacy NDC, 1 package rows20231229_ea0609be-eaa9-4b63-9f07-e2cd974e01ba.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTINOXATEACTIVE MOIETY4Y5P7MUD511

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-00749967-007-01

Ingredients#

Complete SPL Sections#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use: ● 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

Other information

STORAGE AND HANDLING SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-800-322-2036 Monday - Friday (9 a.m. - 5 p.m. EST)

Inactive ingredients

INACTIVE INGREDIENT SECTION

cyclopentasiloxane, water, dimethicone crosspolymer, glycerin, isotridecyl isononanoate, PEG-9 polydimethylsiloxyethyl dimethicone, disteardimonium hectorite, phenoxyethanol, PEG-10 dimethicone, hydrolyzed wheat protein/PVP crosspolymer, disodium stearoyl glutamate, chlorphenesin, methylparaben, lycium barbarum fruit extract, acrylates copolymer, potassium sorbate, ethylparaben, tocopherol, ascorbyl palmitate, panthenol, PEG-9, aluminum hydroxide, citric acid, sodium PCA, urea, trehalose, polyquaternium-51, soluble collagen, sodium hyaluronate; may contain: iron oxides, titanium dioxide, mica

Source Document#

Source XML