Extreme Anti-Wrinkle Care SPF 30

Dosage form: cream
Ingredients: Avobenzone 30.9mg in 1mL, Homosalate 103mg in 1mL, Octisalate 51.5mg in 1mL, Octocrylene 103mg in 1mL, Oxybenzone 51.5mg in 1mL
Labeler: ORLANE, Inc.
NDC Code: 65371-030

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Extreme Anti-Wrinkle Care SPF 30

Repairs wrinkles and limits their formation.

Apply in the morning, avoiding the eye contour.

Contains oxybenzone.

Active Ingredients

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

Distr. ORLANE Sayreville, N.J. 08872.

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label

ORLANE
PARIS

EXTREME
ANTI-WRINKLE CARE
SPF 30
SUNSCREEN

EXTREME ANTI-WRINKLE CARE SPF 30 
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65371-030
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (Avobenzone) Avobenzone30.9 mg  in 1 mL
Homosalate (Homosalate) Homosalate103 mg  in 1 mL
Octisalate (Octisalate) Octisalate51.5 mg  in 1 mL
Octocrylene (Octocrylene) Octocrylene103 mg  in 1 mL
Oxybenzone (Oxybenzone) Oxybenzone51.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Glycerin 
Alkyl (C12-15) Benzoate 
Aluminum Starch Octenylsuccinate 
Coriander 
Dimethicone 
Cetyl Alcohol 
Glyceryl Monostearate 
PEG-75 Stearate 
Docosanol 
Silicon Dioxide 
Phenoxyethanol 
Ceteth-20 
Steareth-20 
Chlorphenesin 
Sodium Dehydroacetate 
.Alpha.-Tocopherol Acetate 
Ethylhexylglycerin 
Carbomer 934 
Sodium Benzoate 
Trolamine 
Xanthan Gum 
Pentylene Glycol 
Jasminum Officinale Flower 
Edetate Sodium 
O-Cymen-5-Ol 
Lactic Acid 
Lysine Hydrochloride 
Hyaluronate Sodium 
Chlorhexidine Gluconate 
Tocopherol 
Packaging
#Item CodePackage Description
1NDC:65371-030-011 BOTTLE, PUMP (BOTTLE) in 1 CARTON
150 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35204/01/2012
Labeler - ORLANE, Inc. (131360992)
Establishment
NameAddressID/FEIOperations
ORLANE, ORLEANS578687469MANUFACTURE(65371-030)

Revised: 03/2012
 
ORLANE, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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