LOREAL PARIS REVITALIFT ANTI WRINKLE FIRMING MOISTURIZER SPF 25- avobenzone, octisalate and octocrylene lotion

LOREAL PARIS REVITALIFT ANTI WRINKLE FIRMING MOISTURIZER SPF 25 by

Drug Labeling and Warnings

LOREAL PARIS REVITALIFT ANTI WRINKLE FIRMING MOISTURIZER SPF 25 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 ingredients

Avobenzone 3%

Octisalate 5%

Octocrylene 7%

Purpose

Sunscreeen

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 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:
o limit time in the sun, especially from 10 a.m. – 2 p.m.
o 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, dimethicone, alcohol denat., propanediol, PTFE, isopropyl isostearate, behenyl alcohol, octyldodecanol, phenoxyethanol, cetyl alcohol, polyacrylamide, ammonium acryloyldimethyltaurate/steareth-25 methacrylate crosspolymer, disodium stearoyl glutamate, vinyl dimethicone/methicone silsequioxane crosspolymer, hydrolyzed soy protein, dimethicone/vinyl dimethicone crosspolymer, C13-14 isoparaffin, PEG-100 stearate, glycine soja (soybean) protein, fragrance, cetearyl alcohol, dimethiconol, tocopheryl acetate, panthenol, retinyl palmitate, laureth-7, capryloyl salicylic acid, acetyl trifluoromethylphenyl valyglycine, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, disodium EDTA, carbomer, caprylyl glycol, cetearyl glucoside, 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LOREAL PARIS REVITALIFT ANTI WRINKLE FIRMING MOISTURIZER SPF 25 
avobenzone, octisalate and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-287
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
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)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALCOHOL (UNII: 3K9958V90M)
PROPANEDIOL (UNII: 5965N8W85T)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)
DOCOSANOL (UNII: 9G1OE216XY)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETYL ALCOHOL (UNII: 936JST6JCN)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
PEG-100 STEARATE (UNII: YD01N1999R)
SOY PROTEIN (UNII: R44IWB3RN5)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PANTHENOL (UNII: WV9CM0O67Z)
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)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
caprylyl glycol (UNII: 00YIU5438U)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
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 WHOLE (UNII: 7M867G6T1U)
.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: 49967-287-01	1 in 1 CARTON	10/02/2017
1		50 mL in 1 JAR; Type 0: Not a Combination Product
2	NDC: 49967-287-02	1 in 1 CARTON	10/02/2017
2		70 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
OTC monograph not final	part352	10/02/2017

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA PRODUCTS, INC.		624244349	manufacture(49967-287)