Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID efbdfe0e-c602-48f6-9faf-dc85298f1741
Route
TOPICAL
Published
Effective Date 2017-03-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (100 mg) Oxybenzone (60 mg) Octisalate (50 mg) Avobenzone (30 mg) Octocrylene (20 mg)
Inactive Ingredients
Water Butylene Glycol Polyethylene Glycol 400 High Density Polyethylene Dimethicone Silicon Dioxide Picea Abies Wood Sodium Ascorbyl Phosphate Vitamin A Palmitate Tocopherol .alpha.-tocopherol Acetate, Dl- Titanium Dioxide Aloe Vera Leaf Bentonite Carbomer Copolymer Type A Sodium Polyacrylate (8000 Mw) Kaolin Ethylhexylglycerin Edetate Disodium Sodium Hydroxide Chlorphenesin Phenoxyethanol

Identifiers & Packaging

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

Description

Avobenzone 3.0% Homosalate 10.0% Octisalate 5.0% Octocrylene 2.0% Oxybenzone 6.0%

Purpose

Sunscreen Sunscreen Sunscreen Sunscreen Sunscreen


Medication Information

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Description

Avobenzone 3.0% Homosalate 10.0% Octisalate 5.0% Octocrylene 2.0% Oxybenzone 6.0%

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 10.0%

Octisalate 5.0%

Octocrylene 2.0%

Oxybenzone 6.0%

Inactive Ingredients

Water, Butylene Glycol, PEG-8, Polyethylene, Dimethicone, Silica, Picea Albies Wood Extract, Sodium Ascorbyl Phosphate, Retinyl Palmitate, Tocopherol, Tocopheryl Acetate, Titanium Dioxide, Aloe Barbadensis Leaf Juice, Bentonite, Methyl Glucose Sesquistearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Polyacrylate, Kaolin, Ethylhexylglycerin, Disodium EDTA, Sodium Hydroxide, Chlorphenesin, Phenoxyethanol.

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

M050912CP       FP155

Principal Display Panel Tube Label

SKIN+PHARMACY®

ADVANCED

SUN

THERAPY

BROAD SPECTRUM

SPF 50 FACE LOTION

UVA/UVB protection

with Polargel® UV Technology

Sunscreen with antioxidant Vitamin A

& Picea Albies Wood Extract for

protection against free radicals

  • Polargel® UV Technology allows

    lower sunscreen actives &

    optimizes performance
  • moisturizing, non-whitening formula

    with broad spectrum protection
  • water resistant (80 minutes)
  • paraben, oil & fragrance free

DERMATOLOGIST TESTED

exclusively at

CVS/pharmacy

3 FL OZ (90 mL)

Principal Display Panel Carton Label

SKIN+

PHARMACY
®

ADVANCED

SUN

THERAPY

BROAD SPECTRUM

SPF 50 FACE LOTION

UVA/UVB protection

with Polargel
®

UV Technology

Sunscreen with antioxidant

Vitamin A & Picea Albies

Wood Extract for protection

against free radicals

  • Polargel® UV Technology

    allows lower sunscreen

    actives & optimizes

    performance
  • moisturizing, non-whitening

    formula with broad

    spectrum protection
  • water resistant (80 minutes)
  • paraben, oil & fragrance free

DERMATOLOGIST TESTED

exclusively at

CVS/pharmacy

Actual Product Size on Side Panel

3 FL OZ (90 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 10.0%

Octisalate 5.0%

Octocrylene 2.0%

Oxybenzone 6.0%

Inactive Ingredients (Inactive ingredients)

Water, Butylene Glycol, PEG-8, Polyethylene, Dimethicone, Silica, Picea Albies Wood Extract, Sodium Ascorbyl Phosphate, Retinyl Palmitate, Tocopherol, Tocopheryl Acetate, Titanium Dioxide, Aloe Barbadensis Leaf Juice, Bentonite, Methyl Glucose Sesquistearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Polyacrylate, Kaolin, Ethylhexylglycerin, Disodium EDTA, Sodium Hydroxide, Chlorphenesin, Phenoxyethanol.

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

M050912CP       FP155

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

SKIN+PHARMACY®

ADVANCED

SUN

THERAPY

BROAD SPECTRUM

SPF 50 FACE LOTION

UVA/UVB protection

with Polargel® UV Technology

Sunscreen with antioxidant Vitamin A

& Picea Albies Wood Extract for

protection against free radicals

  • Polargel® UV Technology allows

    lower sunscreen actives &

    optimizes performance
  • moisturizing, non-whitening formula

    with broad spectrum protection
  • water resistant (80 minutes)
  • paraben, oil & fragrance free

DERMATOLOGIST TESTED

exclusively at

CVS/pharmacy

3 FL OZ (90 mL)

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

SKIN+

PHARMACY
®

ADVANCED

SUN

THERAPY

BROAD SPECTRUM

SPF 50 FACE LOTION

UVA/UVB protection

with Polargel
®

UV Technology

Sunscreen with antioxidant

Vitamin A & Picea Albies

Wood Extract for protection

against free radicals

  • Polargel® UV Technology

    allows lower sunscreen

    actives & optimizes

    performance
  • moisturizing, non-whitening

    formula with broad

    spectrum protection
  • water resistant (80 minutes)
  • paraben, oil & fragrance free

DERMATOLOGIST TESTED

exclusively at

CVS/pharmacy

Actual Product Size on Side Panel

3 FL OZ (90 mL)


Advanced Ingredient Data


Raw Label Data

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