SPL v1
SPL
SPL Set ID b7f927af-d7fb-46ca-99e7-460dd26dd2b3
Route
TOPICAL
Published
Effective Date 2016-03-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (40 g) Octisalate (30 g) Avobenzone (20 g) Oxybenzone Octocrylene
Inactive Ingredients
Water Alkyl (c12-15) Benzoate Butylene Glycol Sodium Cetostearyl Sulfate Glyceryl Monostearate Cetostearyl Alcohol Dimethicone Phenoxyethanol Titanium Dioxide Sodium Polyacrylate (8000 Mw) Bentonite Chlorphenesin Picea Abies Wood Aloe Vera Leaf Sodium Hydroxide Ethylhexylglycerin .alpha.-tocopherol Acetate, Dl- Edetate Disodium Sodium Ascorbyl Phosphate Vitamin A Palmitate Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-04-01

Description

Drug Facts

Purpose

Sunscreen Sunscreen Sunscreen Sunscreen Sunscreen


Medication Information

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Description

Drug Facts

Uses
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging cause by the sun.
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin.

Warnings

For external use only.

Directions
  • Apply liberally 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
Other Information
  • Protect the product in this container from excessive heat and direct sunlight.
Active Ingredients

Avobenzone 3.0%

Homosalate 4.0%

Octisalate 4.0%

Octocrylene 2.0%

Oxybenzone 3.0%

Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Butylene Glycol, VP/Eicosene Copolymer, Sodium Cetearyl Sulfate, Methyl Glucose Sesquistearate, Glyceryl Stearate, Cetearyl Alcohol, Dimethicone, Picea Albies Wood Extract, Aloe Barbadensis (Aloe Vera) Leaf Juice, Tocopheryl Acetate, Retinyl Palmitate, Sodium Ascorbyl Phosphate, Tocopherol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Bentonite, Sodium Polyacrylamide, Disodium EDTA, Titanium Dioxide, Sodium Hydroxide, Phenoxyethanol, Chlorphenesin, Ethylhexylglycerin.

Polargel® is a registered trademark of AMCOL International Corp.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2016 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

Made in the U.S.A. of U.S. and imported components

V-32991

CVS® Quality

Money Back Guarantee

M050899CP FP100

________________________________________________________

end of text

160225

AMCOL Health & Beauty Solutions, Inc. DBA AMCOL Household and Personal Care

301 Laser Lane Lafayette, LA 70507 | www.amcolhpc.com

[email protected]

Principal Display Panel Tube Label

SKIN-PHARMACY® ADVANCED SUN THERAPY

BROAD SPECTRUM SPF 30 SUN LOTION

UVA/UVB protection with Polargel® UV Technology

Sunscreen with antioxidant Vitamins A, C & E for protection against free radicals

Polargel® UV Technology allows lower sunscreen actives & optimizes performance

with Aloe Vera to help keep skin moisturized

water resistant (80 minutes)

paraben, oil & fragrance free

DERMATOLOGIST TESTED

exclusively at CVS/pharmacy

6 FL OZ (180 mL)

Principal Display Panel Carton Label

SKIN-PHARMACY® ADVANCED SUN THERAPY

BROAD SPECTRUM SPF 30 SUN LOTION

UVA/UVB protection with Polargel® UV Technology

Sunscreen with antioxidant Vitamins A, C & E for protection against free radicals

Polargel® UV Technology allows lower sunscreen actives & optimizes performance

with Aloe Vera to help keep skin moisturized

water resistant (80 minutes)

paraben, oil & fragrance free

DERMATOLOGIST TESTED

exclusively at CVS/pharmacy

Actual Product Size on Side Panel

6 FL OZ (180 mL)


Structured Label Content

Uses
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging cause by the sun.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Warnings

For external use only.

Directions
  • Apply liberally 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
Other Information (Other information)
  • Protect the product in this container from excessive heat and direct sunlight.
Active Ingredients (Active ingredients)

Avobenzone 3.0%

Homosalate 4.0%

Octisalate 4.0%

Octocrylene 2.0%

Oxybenzone 3.0%

Inactive Ingredients (Inactive ingredients)

Water, C12-15 Alkyl Benzoate, Butylene Glycol, VP/Eicosene Copolymer, Sodium Cetearyl Sulfate, Methyl Glucose Sesquistearate, Glyceryl Stearate, Cetearyl Alcohol, Dimethicone, Picea Albies Wood Extract, Aloe Barbadensis (Aloe Vera) Leaf Juice, Tocopheryl Acetate, Retinyl Palmitate, Sodium Ascorbyl Phosphate, Tocopherol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Bentonite, Sodium Polyacrylamide, Disodium EDTA, Titanium Dioxide, Sodium Hydroxide, Phenoxyethanol, Chlorphenesin, Ethylhexylglycerin.

Polargel® is a registered trademark of AMCOL International Corp.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2016 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

Made in the U.S.A. of U.S. and imported components

V-32991

CVS® Quality

Money Back Guarantee

M050899CP FP100

________________________________________________________

end of text

160225

AMCOL Health & Beauty Solutions, Inc. DBA AMCOL Household and Personal Care

301 Laser Lane Lafayette, LA 70507 | www.amcolhpc.com

[email protected]

Principal Display Panel Tube Label (Principal Display Panel - Tube Label)

SKIN-PHARMACY® ADVANCED SUN THERAPY

BROAD SPECTRUM SPF 30 SUN LOTION

UVA/UVB protection with Polargel® UV Technology

Sunscreen with antioxidant Vitamins A, C & E for protection against free radicals

Polargel® UV Technology allows lower sunscreen actives & optimizes performance

with Aloe Vera to help keep skin moisturized

water resistant (80 minutes)

paraben, oil & fragrance free

DERMATOLOGIST TESTED

exclusively at CVS/pharmacy

6 FL OZ (180 mL)

Principal Display Panel Carton Label (Principal Display Panel - Carton Label)

SKIN-PHARMACY® ADVANCED SUN THERAPY

BROAD SPECTRUM SPF 30 SUN LOTION

UVA/UVB protection with Polargel® UV Technology

Sunscreen with antioxidant Vitamins A, C & E for protection against free radicals

Polargel® UV Technology allows lower sunscreen actives & optimizes performance

with Aloe Vera to help keep skin moisturized

water resistant (80 minutes)

paraben, oil & fragrance free

DERMATOLOGIST TESTED

exclusively at CVS/pharmacy

Actual Product Size on Side Panel

6 FL OZ (180 mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)