LOREAL PARIS REVITALIFT ANTI-WRINKLE PLUS FIRMING BROAD SPECTRUM SPF 25 MOISTURIZER SUNSCREEN- avobenzone, homosalate, octisalate and octocrylene cream

LOreal Paris REVITALIFT Anti-Wrinkle plus Firming Broad Spectrum SPF 25 Moisturizer Sunscreen by

Drug Labeling and Warnings

LOreal Paris REVITALIFT Anti-Wrinkle plus Firming Broad Spectrum SPF 25 Moisturizer Sunscreen by is a Prescription 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 

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Octocrylene 7%

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 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, glycerin, alcohol denat., propanediol, dimethicone, butyloctyl salicylate, isopropyl isostearate, behenyl alcohol, octyldodecanol, boron nitride, phenoxyethanol, cetyl alcohol, polyacrylamide, disodium stearoyl glutamate, hydrolyzed soy protein, silica, ammonium acryloyldimethyltaurate/steareth-25 methacrylate crosspolymer, dimethicone/vinyl dimethicone crosspolymer, c13-14 isoalkane, glycine soja (soybean) protein, fragrance, PEG-100 stearate, cetearyl alcohol, panthenol, tocopheryl acetate, retinyl palmitate, laureth-7, capryloyl salicylic acid, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, trisodium ethylenediamine disuccinate, caprylyl glycol, cetearyl glucoside, citric acid, carbomer, calcium PCA, sodium cocoyl glutamate, pentylene glycol, ethylhexylglycerin, sodium benzoate, benzyl salicylate, benzyl alcohol, yeast extract, benzyl benzoate, potassium sorbate, linalool, centella asiatica extract, hexyl cinnamal, citronellol, limonene, geraniol, alpha-isomethyl ionone, salicyloyl phytosphingosine, tocopherol

Questions or comments?

L'Oreal USA S/D, Inc., Dist., 10 Hudson Yards,

New York, NY 10001 1-800-322-2036

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LOREAL PARIS REVITALIFT ANTI-WRINKLE PLUS FIRMING BROAD SPECTRUM SPF 25 MOISTURIZER SUNSCREEN 
avobenzone, homosalate, octisalate and octocrylene cream

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 49967-329
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	50 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
PROPANEDIOL (UNII: 5965N8W85T)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)
DOCOSANOL (UNII: 9G1OE216XY)
OCTYLDODECANOL (UNII: 461N1O614Y)
BORON NITRIDE (UNII: 2U4T60A6YD)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETYL ALCOHOL (UNII: 936JST6JCN)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
SOY PROTEIN (UNII: R44IWB3RN5)
PEG-100 STEARATE (UNII: YD01N1999R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
LAURETH-7 (UNII: Z95S6G8201)
CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CALCIUM PIDOLATE (UNII: 7Y2LVU5EKK)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM BENZOATE (UNII: OJ245FE5EU)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
BENZYL ALCOHOL (UNII: LKG8494WBH)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
BENZYL BENZOATE (UNII: N863NB338G)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
GERANIOL (UNII: L837108USY)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-329-01	1 in 1 CARTON	04/25/2024
1		50 mL in 1 JAR; Type 0: Not a Combination Product
2	NDC: 49967-329-02	1 in 1 CARTON	04/25/2024
2		75 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
export only		04/25/2024

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA PRODUCTS, INC		624244349	manufacture(49967-329)