EXTREME ANTI-WRINKLE CARE SPF 30- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream

Extreme Anti-Wrinkle Care SPF 30 by

Drug Labeling and Warnings

Extreme Anti-Wrinkle Care SPF 30 by is a Otc medication manufactured, distributed, or labeled by ORLANE, Inc., ORLANE, ORLEANS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

Repairs wrinkles and limits their formation.

DOSAGE & ADMINISTRATION

Apply in the morning, avoiding the eye contour.

WARNINGS

Contains oxybenzone.

Active Ingredients

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 10%, Oxybenzone 5%.

SPL UNCLASSIFIED SECTION

Distr. ORLANE Sayreville, N.J. 08872.

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label

ORLANE
PARIS

EXTREME
ANTI-WRINKLE CARE
SPF 30
SUNSCREEN

INGREDIENTS AND APPEARANCE

EXTREME ANTI-WRINKLE CARE SPF 30 
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65371-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30.9 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	103 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	51.5 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	103 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	51.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)
Coriander (UNII: 1OV56052IK)
Dimethicone (UNII: 92RU3N3Y1O)
Cetyl Alcohol (UNII: 936JST6JCN)
Glyceryl Monostearate (UNII: 230OU9XXE4)
PEG-75 Stearate (UNII: OT38R0N74H)
Docosanol (UNII: 9G1OE216XY)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Phenoxyethanol (UNII: HIE492ZZ3T)
Ceteth-20 (UNII: I835H2IHHX)
Steareth-20 (UNII: L0Q8IK9E08)
Chlorphenesin (UNII: I670DAL4SZ)
Sodium Dehydroacetate (UNII: 8W46YN971G)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Ethylhexylglycerin (UNII: 147D247K3P)
Carbomer 934 (UNII: Z135WT9208)
Sodium Benzoate (UNII: OJ245FE5EU)
Trolamine (UNII: 9O3K93S3TK)
Xanthan Gum (UNII: TTV12P4NEE)
Pentylene Glycol (UNII: 50C1307PZG)
Jasminum Officinale Flower (UNII: 0Q8K841432)
Edetate Sodium (UNII: MP1J8420LU)
O-Cymen-5-Ol (UNII: H41B6Q1I9L)
Lactic Acid (UNII: 33X04XA5AT)
Lysine Hydrochloride (UNII: JNJ23Q2COM)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Chlorhexidine Gluconate (UNII: MOR84MUD8E)
Tocopherol (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65371-030-01	1 in 1 CARTON
1		50 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	04/01/2012

Labeler - ORLANE, Inc. (131360992)

Establishment
Name	Address	ID/FEI	Business Operations
ORLANE, ORLEANS		578687469	MANUFACTURE(65371-030)