Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID e04c3da6-bcf0-4032-a033-7a14e00d447a
Route
TOPICAL
Published
Effective Date 2010-07-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ensulizole (10 mg) Octisalate (40 mg) Octocrylene
Inactive Ingredients
Water Glycerin Edetate Disodium Tea Leaf Titanium Dioxide Glyceryl Isostearate Aluminum Oxide Dimethicone Stearyl Alcohol Sorbitan Monostearate Cetyl Alcohol Alpha-tocopherol Acetate Stearoxytrimethylsilane Polyoxyl 100 Stearate Stearic Acid Benzyl Alcohol Panthenol Propylene Glycol Propylparaben Methylparaben Diazolidinyl Urea .alpha.-glucan Oligosaccharide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-07-19

Description

Active Ingredients: Ensulizole, 1.0%, Octisaltae, 4.0%, Octocrylene, 1.0%                        


Medication Information

Warnings and Precautions
Warnings



Keep out of reach of children.



For external use only.

Avoid contact with eyes.

Stop use and consult a doctor if irritation develops.

Indications and Usage


CVS/pharmacy Dry Skin Therapy Daily Protection Body Lotion provides skin

with intense moisturizers and SPF 15. This helps keep your skin moisturized

and protected from incidental exposure to the sun's harmful rays. Antioxidants

and Vitamine E moisturize dry skin, while a blend of sunscreens provide wide

ranging UVA/UVB protection.



-Formula contains a blend of sunscreens, including titanium dioxide, providing

broad spectrum UVA/UVB protection

- Enriched with antioxidants

- Non-greasy formula

- Fragrance free
Dosage and Administration


Directions 





Apply generously to hands and body daily.



Reapply as needed.

Description

Active Ingredients: Ensulizole, 1.0%, Octisaltae, 4.0%, Octocrylene, 1.0%                        

Section 50565-1


Warnings: Keep out of reach of children. 
Section 51727-6
Other Ingredients



Water, Glycerin, Sodium Carboxylmethyl Beta-Glucan, Dimethicone, Isopropyl Isostearate,

Polyacrylamide, Triethanolamine, Boron Nitride, Sorbitan Stearate, Cetyl Alcohol, Alumina,

Simethicone, C13-14 Isoparaffin, Panthenol, Tocopheryl Acetate, Stearyl Alcohol, Titanium Dioxide,

Behenyl Alcohol, Dimethiconol, Cyclomethicon, Benzyl Alcohol, Diazolidinyl Urea, Propylene Glycol,

Laureth-7, Propylparaben, Disodium EDTA, PEG-100 Stearate, Stearic Acid,  Methylparaben, Cetaryl Alcohol,

Cetaryl Glucoside

Section 51945-4
Section 55105-1


CVS/pharmacy Dry Skin Therapy Daily Protection Body Lotion provides skin

with intense moisturizers and SPF 15. This helps keep your skin moisturized

and protected from incidental exposure to the sun's harmful rays. Antioxidants

and Vitamine E moisturize dry skin, while a blend of sunscreens provide wide

ranging UVA/UVB protection.



-Formula contains a blend of sunscreens, including titanium dioxide, providing

broad spectrum UVA/UVB protection

- Enriched with antioxidants

- Non-greasy formula

- Fragrance free





Section 55106-9
Active Ingredients: Ensulizole, 1.0%, Octisaltae, 4.0%, Octocrylene, 1.0%                        






Structured Label Content

Indications and Usage (34067-9)


CVS/pharmacy Dry Skin Therapy Daily Protection Body Lotion provides skin

with intense moisturizers and SPF 15. This helps keep your skin moisturized

and protected from incidental exposure to the sun's harmful rays. Antioxidants

and Vitamine E moisturize dry skin, while a blend of sunscreens provide wide

ranging UVA/UVB protection.



-Formula contains a blend of sunscreens, including titanium dioxide, providing

broad spectrum UVA/UVB protection

- Enriched with antioxidants

- Non-greasy formula

- Fragrance free
Dosage and Administration (34068-7)


Directions 





Apply generously to hands and body daily.



Reapply as needed.

Warnings and Precautions (34071-1)
Warnings



Keep out of reach of children.



For external use only.

Avoid contact with eyes.

Stop use and consult a doctor if irritation develops.

Section 50565-1 (50565-1)


Warnings: Keep out of reach of children. 
Section 51727-6 (51727-6)
Other Ingredients



Water, Glycerin, Sodium Carboxylmethyl Beta-Glucan, Dimethicone, Isopropyl Isostearate,

Polyacrylamide, Triethanolamine, Boron Nitride, Sorbitan Stearate, Cetyl Alcohol, Alumina,

Simethicone, C13-14 Isoparaffin, Panthenol, Tocopheryl Acetate, Stearyl Alcohol, Titanium Dioxide,

Behenyl Alcohol, Dimethiconol, Cyclomethicon, Benzyl Alcohol, Diazolidinyl Urea, Propylene Glycol,

Laureth-7, Propylparaben, Disodium EDTA, PEG-100 Stearate, Stearic Acid,  Methylparaben, Cetaryl Alcohol,

Cetaryl Glucoside

Section 51945-4 (51945-4)
Section 55105-1 (55105-1)


CVS/pharmacy Dry Skin Therapy Daily Protection Body Lotion provides skin

with intense moisturizers and SPF 15. This helps keep your skin moisturized

and protected from incidental exposure to the sun's harmful rays. Antioxidants

and Vitamine E moisturize dry skin, while a blend of sunscreens provide wide

ranging UVA/UVB protection.



-Formula contains a blend of sunscreens, including titanium dioxide, providing

broad spectrum UVA/UVB protection

- Enriched with antioxidants

- Non-greasy formula

- Fragrance free





Section 55106-9 (55106-9)
Active Ingredients: Ensulizole, 1.0%, Octisaltae, 4.0%, Octocrylene, 1.0%                        






Advanced Ingredient Data


Raw Label Data

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