MAYBELLINE NEW YORK INSTANT AGE REWIND ERASER TREATMENT MAKEUP OCTINOXATE BROAD SPECTRUM SPF 20 SUNSCREEN PLUS PROVITAMIN B5- octinoxate lotion

MAYBELLINE NEW YORK INSTANT AGE REWIND ERASER TREATMENT MAKEUP OCTINOXATE BROAD SPECTRUM SPF 20 SUNSCREEN PLUS PROVITAMIN B5 by

Drug Labeling and Warnings

MAYBELLINE NEW YORK INSTANT AGE REWIND ERASER TREATMENT MAKEUP OCTINOXATE BROAD SPECTRUM SPF 20 SUNSCREEN PLUS PROVITAMIN B5 by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'OREAL USA PRODUCTS, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Octinoxate 7.5%

Purpose

Sunscreen

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

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 sunscren if swimming or sweating
• Sun Protection Measures. Spending time in the sun increases our 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

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, silica silylate, potassium sorbate, ethylparaben, tocopherol, ascorbyl palmitate, panthenol, aluminum hydroxide, citric acid, BHT, sodium PCA, propylene glycol, urea, EDTA, tin oxide, ethylhexylglycerin, trehalose, polyquaternium-51, soluble collagen, sodium hyaluronate, trisodium EDTA, benzoic acid; may contain: titanium dioxide, mica, iron oxides

Questions or comments?

1-800-322-2036

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MAYBELLINE NEW YORK INSTANT AGE REWIND ERASER TREATMENT MAKEUP OCTINOXATE BROAD SPECTRUM SPF 20 SUNSCREEN PLUS PROVITAMIN B5 
octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
CHLORPHENESIN (UNII: I670DAL4SZ)
METHYLPARABEN (UNII: A2I8C7HI9T)
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ETHYLPARABEN (UNII: 14255EXE39)
TOCOPHEROL (UNII: R0ZB2556P8)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
PANTHENOL (UNII: WV9CM0O67Z)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
UREA (UNII: 8W8T17847W)
EDETIC ACID (UNII: 9G34HU7RV0)
STANNIC OXIDE (UNII: KM7N50LOS6)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TREHALOSE (UNII: B8WCK70T7I)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
EDETATE TRISODIUM (UNII: 420IP921MB)
BENZOIC ACID (UNII: 8SKN0B0MIM)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-202-01	20 mL in 1 BOTTLE; 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 PRODUCTS, INC		624244349	manufacture(49967-202)