Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 190c28dd-4b9a-4410-a48d-bfff81fa21a5
Route
TOPICAL
Published
Effective Date 2011-07-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ensulizole (18 mg) Octinoxate (75 mg)
Inactive Ingredients
Water Glycerin Edetate Disodium Xanthan Gum Titanium Dioxide Butylene Glycol Aluminum Oxide Dimethicone Stearyl Alcohol Trolamine Cetyl Alcohol Sodium Stearoyl Lactylate Docosanol .alpha.-tocopherol Acetate Vitamin A Palmitate Cetostearyl Alcohol Panthenol Cetearyl Glucoside Propylparaben Methylparaben Diazolidinyl Urea Butylated Hydroxytoluene Potassium Cetyl Phosphate Chamaemelum Nobile Flower Stearic Acid Alkyl (c12-15) Benzoate D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-07-19

Description

Active Ingredients: Ensulizole, 1.8%, Octinoxate, 7.5%        


Medication Information

Warnings and Precautions
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.

Indications and 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





Dosage and 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.

Description

Active Ingredients: Ensulizole, 1.8%, Octinoxate, 7.5%        

Section 50565-1


Keep out of reach of children.

Section 51727-6
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



Section 51945-4




Section 55105-1


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

Section 55106-9
Active Ingredients:



Ensulizole, 1.8%, Octinoxate, 7.5%        






Structured Label Content

Indications and Usage (34067-9)




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





Dosage and Administration (34068-7)


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.

Warnings and Precautions (34071-1)
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.

Section 50565-1 (50565-1)


Keep out of reach of children.

Section 51727-6 (51727-6)
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



Section 51945-4 (51945-4)




Section 55105-1 (55105-1)


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

Section 55106-9 (55106-9)
Active Ingredients:



Ensulizole, 1.8%, Octinoxate, 7.5%        






Advanced Ingredient Data


Raw Label Data

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