CVS ADVANCED DEEP SET WRINKLE THERAPY W/SPF15- ensulizole and octinoxate lotion

CVS Advanced Deep Set Wrinkle Therapy w/SPF15 by

Drug Labeling and Warnings

CVS Advanced Deep Set Wrinkle Therapy w/SPF15 by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Pharma Pac, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Ensulizole, 1.8%, Octinoxate, 7.5%       

PURPOSE

CVS/pharmacy Advanced Deep-Set Wrinkle Day Therapy

What age related skin issues does our advanced formula address?

Deep-set wrinkles commonly appear on the forehead, brow and in the form
of frown lines and crow's feet. With daily use, our deep wrinkle lotion evens out the
surface of wrinkles and decreases their appearance.

Our Pro-Retinol formula also provides the advanced skin protection of SPF 15 sunscreen
to help protect the skin from UV damage.

Multi-Action Benefits

Smooths Skin:

- Pro-Retinol Vitamin A firms and tones skin, improving elasticity.
- Encapsulated technology provides continuous benefits in fighting the
signs of aging
- Diminishes appearance of deep-set wrinkles.

Hydrates and Protects Dry Skin:

- Essential nutrients replenish moisture, maintaining skin's natural balance and
enhancing softness
- SPF 15 helps protect the skin

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS & USAGE

Recomended regimen

Step 1 Cleanse skin thoroughly

Step 2 Apply CVS/pharmacy Day and Night Eye Cream

Step 3 AM: Follow-up with CVS/pharmacy Deep-Set Wrinkle Day Treatment.
           PM: CVS/pharmacy Deep-Set Wrinkle Night Cream.

How and When to Use

Every morning after thoroughly cleansing skin, apply alone or under makeup.
Gently smooth onto face and neck until completely absorbed.

To use as a sunscreen apply to face prior to sun exposure

WARNINGS

Warnings

For external use only, not to be swallowed. Avoid contact with eyes.
If contact occurs, rinse eyes thoroughly with water. Discontinue use if signs of irritation
or rash appear. If irritation or rash persists, consult a doctor.

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Recommended Application

Step 1 Cleanse skin thoroughly

Step 2 Apply CVS/Pharmacy Day and NIght Cream

Step 3 AM: Follow-up with CVS?Pharmacy Advanced Anti-Wrinkle and Firming Day Cream
            PM: Follow-up with CVS/Pharmacy Advanced Anti-Wrinkle and Firming Night Cream

How and When to Use

Every day prior to sun exposure, gently smooth onto face and neck until completely absorbed. Use in the morning; alone or under makeup.

To use as a sunscreen, apply to face prior to sun exposure.

INACTIVE INGREDIENT

Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Fragrance, Cetyl Alcohol, PolyGlyceryl-10 Pentastearate,
Behenyl Alcohol, Sodium Stearoyl Lactylate, Retinyl Palmitate, Butylene Glycol,
Titanium Dioxide, Alumina, Simethicone, Potassium Cetyl Phosphate, Propylene Glycol,
Triethanolamine, Tocopheryl Acetate, Cetearyl Alcohol, Butylated Hydroxytoluene, Panthenol,
Xanthan Gum, Diazolidinyl Urea, Cetearyl Glocoside, Chamomila Recutita (Matricaria) Flower
Extract, Dimethicone, Disodium EDTA, Propylparaben, Glycerin, Methylparaben, Red 33

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS ADVANCED DEEP SET WRINKLE THERAPY W/SPF15 
ensulizole and octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-063
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	18 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
XANTHAN GUM (UNII: TTV12P4NEE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALUMINUM OXIDE (UNII: LMI26O6933)
DIMETHICONE (UNII: 92RU3N3Y1O)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TROLAMINE (UNII: 9O3K93S3TK)
CETYL ALCOHOL (UNII: 936JST6JCN)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
DOCOSANOL (UNII: 9G1OE216XY)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PANTHENOL (UNII: WV9CM0O67Z)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-063-09	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	07/19/2011

Labeler - CVS Pharmacy (062312574)

Registrant - Pharma Pac, LLC (140807475)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Pac, LLC		140807475	manufacture