LOREAL PARIS INFALLIBLE UP TO 32H FRESH WEAR FOUNDATION BROAD SPECTRUM SPF 25 SUNSCREEN- octinoxate and titanium dioxide liquid

LOreal Paris Infallible UP TO 32H Fresh Wear Foundation Broad Spectrum SPF 25 Sunscreen by

Drug Labeling and Warnings

LOreal Paris Infallible UP TO 32H Fresh Wear Foundation Broad Spectrum SPF 25 Sunscreen 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 ingredients

Octinoxate 6.7%

Titanium dioxide 4.6%

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

Flammable until dry.

Do not use near fire, flames or heat.

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:

• shake well beore using
• 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 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, dimethicone, isododecane, alcohol denat., trimethylsiloxysilicate, butylene glycol, PEG-10 dimethicone, perlite, synthetic fluorphlogopite, nylon-12, isopropyl lauroyl sarcosinate, diisopropyl sebacate, HDI/trimethylol hexyllactone crosspolymer, disteardimonium hectorite, BIS-PEG/PPG-14/14 dimethicone, magnesium sulfate, aluminum hydroxide, phenoxyethanol, disodium stearoyl glutamate, hydrogen dimethicone, cellulose, dipentaerythrityl tetrahydroxystearate/tetraisostearate, ascorbyl glucoside, silica silylate, fragrance, calcium aluminum borosilicate, tocopherol, silica, hexyl cinnamal, benzyl salicylate, BHT, linalool, alpha-isomethyl ionone, benzyl alcohol, citronellol; may contain: titanium dioxide, iron oxides, bismuth oxychloride, mica

Questions or comments?

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PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LOREAL PARIS INFALLIBLE UP TO 32H FRESH WEAR FOUNDATION BROAD SPECTRUM SPF 25 SUNSCREEN 
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-815
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	67 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	46 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISODODECANE (UNII: A8289P68Y2)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PERLITE (UNII: 0SG101ZGK9)
NYLON-12 (UNII: 446U8J075B)
ISOPROPYL LAUROYL SARCOSINATE (UNII: LYR06W430J)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
DIPENTAERYTHRITYL TETRAHYDROXYSTEARATE/TETRAISOSTEARATE (UNII: 230K0823CE)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
TOCOPHEROL (UNII: R0ZB2556P8)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
BENZYL ALCOHOL (UNII: LKG8494WBH)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-815-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/01/2024

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA PRODUCTS, INC		624244349	manufacture(49967-815)