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Prevage Anti Aging Moisture Broad Spectrum Sunscreen SPF 30

Dosage form: lotion
Ingredients: OCTINOXATE 35mg in 50mL, OCTISALATE 25mg in 50mL, OXYBENZONE 25mg in 50mL, OCTOCRYLENE 11mg in 50mL, AVOBENZONE 10mg in 50mL
Labeler: Elizabeth Arden, Inc
NDC Code: 67938-0904

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.

BB0904

DESCRIPTION

PREVAGE Anti-aging Skincare helps protect and correct skin’s appearance from environmental threats, a leading cause of visible aging signs, for younger-looking, more beautiful skin. This high performance multi-defense moisturizer with advanced Idebenone technology, a powerful environmental protectant, and broad spectrum UVA/UVB sunscreens, helps protect against the visible signs of aging as it minimizes the appearance of existing sun damage – fine lines, wrinkles and discolorations. Locks in moisture to enhance the benefits of PREVAGE Anti-aging Daily Serum.

INDICATIONS AND USAGE

To Use: Massage onto cleansed face and neck daily after PREVAGE Anti-aging Daily Serum.

Directions For Sunscreen Use: Apply liberally 15 minutes before sun exposure. Reapply: at least every 2 hours 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 of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. – 2 p.m. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: Ask a doctor.

WARNINGS

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.

OTC - ACTIVE INGREDIENT

Active Ingredients: Octinoxate, 7.50% , Octisalate, 5.00%, Oxybenzone, 5.00%, Octocrylene, 2.20%, Avobenzone, 2.00%.

INACTIVE INGREDIENT

Other Ingredients: Water/Aqua/Eau, Glycerin, Dimethicone, Cetearyl Alcohol, C12-15 Alkyl Benzoate, Propylene Glycol, PEG-40 Hydrogenated Castor Oil, Potassium Cetyl Phosphate, Glyceryl Polyacrylate, Glyceryl Stearate, Butyrospermum Parkii (Shea Butter), Ergothioneine, Hydroxydecyl Ubiquinoyl Dipalmitoyl Glycerate, Sodium Hyaluronate, Hydrogenated Palm Glycerides, Sodium PCA, Trehalose, Urea, Polyquaternium-51, Carbomer, Sodium Hydroxide, Mica, Cylcohexasiloxane, Cyclopentasiloxane, Parfum/Fragrance, Alpha-Isomethyl Ionone, Linaloo, Benzoic Acid, Methylparaben, Phenoxyethanol, Chlorphenesin, Iron Oxisdes (CI 77492), Red 4 (CI 14700), Titanium Dioxide (CI 77891), Yellow 5 (CI 19140).

DOSAGE & ADMINISTRATION

Massage on to face and neck.

OTC - 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.

OTC - PURPOSE

Provides SPF 30 Sun Protection.

OTC - WHEN USING

Keep out of eyes.

 

PREVAGE ANTI AGING MOISTURE BROAD SPECTRUM SUNSCREEN SPF 30 
octinoxate, octisalate, oxybenzone, octocrylene, and avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-0904
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE35 mg  in 50 mL
OCTISALATE (OCTISALATE) OCTISALATE25 mg  in 50 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE25 mg  in 50 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE11 mg  in 50 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE10 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
DIMETHICONE 
CETOSTEARYL ALCOHOL 
ALKYL (C12-15) BENZOATE 
PROPYLENE GLYCOL 
POLYOXYL 40 HYDROGENATED CASTOR OIL 
POTASSIUM CETYL PHOSPHATE 
GLYCERYL MONOSTEARATE 
CYCLOMETHICONE 6 
PHENOXYETHANOL 
METHYLPARABEN 
CYCLOMETHICONE 5 
MICA 
SODIUM PYRROLIDONE CARBOXYLATE 
UREA 
CHLORPHENESIN 
BENZOIC ACID 
SODIUM HYDROXIDE 
TREHALOSE 
HYALURONATE SODIUM 
Packaging
#Item CodePackage Description
1NDC:67938-0904-11 BOTTLE, PUMP in 1 BOX
1NDC:67938-0904-250 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/04/2009
Labeler - Elizabeth Arden, Inc (849222187)

Revised: 04/2013
 
Elizabeth Arden, Inc

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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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