PREVAGE ANTI-AGING EYE CREAM SPF 15- octinoxate, oxybenzone cream

Prevage Anti-aging eye cream SPF 15 by

Drug Labeling and Warnings

Prevage Anti-aging eye cream SPF 15 by is a Otc medication manufactured, distributed, or labeled by Revlon, Englewood Lab. INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Octinoxate 4.1 %

Oxybenzone 1.4 %

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

Uses

Helps proevent sunburn

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

WARNINGS AND PRECAUTIONS

- Skin Cancer/Skin Aging Alert: Spending time in the sun inceases your risk of ksin cancer and easly skin aging. his product has been shown only to proevent subbrun, not skin cancer or early skin aging.

- For external use only

- Do not use on danaged or broken skin

- Stop using and ask a doctor if rash occurs

Directions for Sunscreen Use:

-Apply liberally 15 minutes before sun exposure

-Repply: at least every 2 hours

Children under 6 months: Ask a doctor

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PREVAGE ANTI-AGING EYE CREAM SPF 15 
octinoxate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10967-685
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	1.4 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4.1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
STEARETH-100 (UNII: 4OH5W9UM87)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCEROPHOSPHOINOSITOL LYSINE (UNII: X34K43QI7A)
SORBITAN TRISTEARATE (UNII: 6LUM696811)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
HYDROXYDECYL UBIQUINOYL DIPALMITOYL GLYCERATE (UNII: OV1BT2N8RC)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
COCOA BUTTER (UNII: 512OYT1CRR)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SIGESBECKIA ORIENTALIS WHOLE (UNII: ZM9Q0FEI4Z)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
ISODON RUBESCENS WHOLE (UNII: 2J2179ITFU)
DIMETHICONE 1000 (UNII: MCU2324216)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
SORBIC ACID (UNII: X045WJ989B)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
TREHALOSE (UNII: B8WCK70T7I)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
UREA (UNII: 8W8T17847W)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
BENZOIC ACID (UNII: 8SKN0B0MIM)
CHLORPHENESIN (UNII: I670DAL4SZ)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BIS-PEG-12 DIMETHICONE (70 MPA.S) (UNII: 2JDK5W22H4)
TRIACETIN (UNII: XHX3C3X673)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
POVIDONE (UNII: FZ989GH94E)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
YELLOW WAX (UNII: 2ZA36H0S2V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10967-685-61	15 g in 1 JAR; Type 0: Not a Combination Product	01/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/02/2020

Labeler - Revlon (788820165)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab. INC		080987545	manufacture(10967-685)