MAYBELLINE NEW YORK FIT DEWY PLUS SMOOTH NORMAL TO DRY BROAD SPECTRUM SPF 18 SUNSCREEN- octinoxate lotion

Maybelline New York Fit Dewy Plus Smooth Normal to Dry Broad Spectrum SPF 18 Sunscreen by

Drug Labeling and Warnings

Maybelline New York Fit Dewy Plus Smooth Normal to Dry Broad Spectrum SPF 18 Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'Oreal USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Octinoxate 7%

Purpose

Sunscreen

Use

• helps prevent sunburn

Warnings

For external use only

Do not use

on damaged or broken skin

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.

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

● children under 6 months of age: Ask a doctor

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, cyclopentasiloxane, dimethicone, glycerin, isotridectyl isononanoate, PEG-9 polydimethylsiloxyethyl dimethicone, disteardimonium hectorite, dimethicone/polyglycerin-3 crosspolymer, sodium chloride, phenoxyethanol, PEG-10 dimethicone, methylparaben, disodium stearoyl glutamate, silica silylate, chlorphenesin, fragrance, trisodium ethylenediamine disuccinate, tocopherol, ascorbyl palmitate, aluminum hydroxide, dipropylene glycol, BHT, alpha-isomethyl ionone; may contain: titanium dioxide, iron oxides

Questions or comments?

1-800-322-2036

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INGREDIENTS AND APPEARANCE

MAYBELLINE NEW YORK FIT DEWY PLUS SMOOTH NORMAL TO DRY BROAD SPECTRUM SPF 18 SUNSCREEN 
octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82046-648
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER (UNII: 2P2G24V6T9)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
CHLORPHENESIN (UNII: I670DAL4SZ)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
TOCOPHEROL (UNII: R0ZB2556P8)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BHT (UNII: 1P9D0Z171K)
ALPHA-ISOMETHYL IONONE (UNII: 9XP4LC555B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82046-648-01	30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	01/14/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/14/2024

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA, Inc.		624244349	manufacture(82046-648) , pack(82046-648)