Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID ab9157da-7e88-4e3c-9097-287c3ef973e6
Route
TOPICAL
Published
Effective Date 2017-02-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (40 mg) Octisalate (30 mg) Avobenzone (20 mg) 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

Avobenzone 3.0% Homosalate 4.0% Octisalate 4.0% Octocrylene 2.0% Oxybenzone 3.0%

Purpose

Sunscreen Sunscreen Sunscreen Sunscreen Sunscreen


Medication Information

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Description

Avobenzone 3.0% Homosalate 4.0% Octisalate 4.0% Octocrylene 2.0% Oxybenzone 3.0%

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 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     M050899CP     FP100

CVS® Quality

Money Back Guarantee

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 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     M050899CP     FP100

CVS® Quality

Money Back Guarantee

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

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