PREVAGE ANTI-AGING MOISTURE CREAM- octinoxate, octisalate, oxybenzone, octocrylene, avobenzone cream

Prevage Anti-aging Moisture Cream by

Drug Labeling and Warnings

Prevage Anti-aging Moisture Cream by is a Otc medication manufactured, distributed, or labeled by Revlon Consumer Products Corp, ENGLEWOOD LAB, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Inactive ingredients

WATER/AQUA/EAU, DIMETHICONE, BUTYLENE GLYCOL, C12-15 ALKYL BENZOATE, ISOSTEARYL NEOPENTANOATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, THEOBROMA CACAO (COCOA) SEED BUTTER, CYCLOPENTASILOXANE, PROPYLENE GLYCOL, PPG-2 ISOCETETH-20 ACETATE, GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, ACRYLAMIDE/SODIUM ACRYLATE COPOLYMER, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, CAPRYLYL GLYCOL, CARBOMER, CETEARYL ALCOHOL, CETEARYL DIMETHICONE CROSSPOLYMER, CYCLOHEXASILOXANE, DIMETHICONE CROSSPOLYMER, DIMETHICONOL, ERGOTHIONEINE, HEXYLENE GLYCOL, HIBISCUS ABELMOSCHUS SEED EXTRACT, HYDROGENATED LECITHIN, HYDROGENATED PHOSPHATIDYLCHOLINE, HYDROXYDECYL UBIQUINOYL DIPALMITOYL GLYCERATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ISOHEXADECANE, MICA, MINERAL OIL/PARAFFINUM LIQUIDUM/HUILE MINERALE, PARFUM/FRAGRANCE, PEG-8, PHENYL TRIMETHICONE, PHOSPHOLIPIDS, POLYPHOSPHORYLCHOLINE GLYCOL ACRYLATE, POLYQUATERNIUM-51, POLYSORBATE 60, RETINYL LINOLEATE, SODIUM HYALURONATE, SODIUM HYDROXIDE, SODIUM PCA, SUCROSE, TREHALOSE, TRIDECETH-6, UREA, XANTHAN GUM, BHT, ALPHA-ISOMETHYL IONONE, LINALOOL, BENZOIC ACID, CHLORPHENESIN, METHYLPARABEN, PHENOXYETHANOL, PROPYLPARABEN, IRON OXIDES (CI 77492), RED 4 (CI 14700), TITANIUM DIOXIDE (CI 77891), YELLOW 5 (CI 19140)

Active Ingredient Section

OCTINOXATE 7.5%

OCTISALATE 5.0%

OXYBENZONE 5.0%

OCTOCRYLENE 2.2%

AVOBENZONE 2.0%

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.

WHEN USING

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PREVAGE ANTI-AGING MOISTURE CREAM 
octinoxate, octisalate, oxybenzone, octocrylene, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10967-688
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.2 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
HYDROXYDECYL UBIQUINOYL DIPALMITOYL GLYCERATE (UNII: OV1BT2N8RC)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
ISOHEXADECANE (UNII: 918X1OUF1E)
MICA (UNII: V8A1AW0880)
SHEA BUTTER (UNII: K49155WL9Y)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
CHLORPHENESIN (UNII: I670DAL4SZ)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOMER 1342 (UNII: 809Y72KV36)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
DIMETHICONE 1000 (UNII: MCU2324216)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
PPG-2 ISOCETETH-20 ACETATE (UNII: BI6C7YO419)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
COCOA BUTTER (UNII: 512OYT1CRR)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)
TREHALOSE (UNII: B8WCK70T7I)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ACRYLAMIDE (UNII: 20R035KLCI)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ERGOTHIONEINE (UNII: BDZ3DQM98W)
XANTHAN GUM (UNII: TTV12P4NEE)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
BENZOIC ACID (UNII: 8SKN0B0MIM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
UREA (UNII: 8W8T17847W)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ABELMOSCHUS MOSCHATUS SEED (UNII: UN2QZ55I88)
POLYSORBATE 60 (UNII: CAL22UVI4M)
RETINYL LINOLEATE (UNII: 61911N8D6W)
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10967-688-17	1 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 Consumer Products Corp (788820165)

Establishment
Name	Address	ID/FEI	Business Operations
ENGLEWOOD LAB, INC		080987545	manufacture(10967-688)