SPL v1
SPL
SPL Set ID bb8570e1-e3e6-4e53-867f-2376bd575348
Route
TOPICAL
Published
Effective Date 2016-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (100 g) Octisalate (50 g) Avobenzone (30 g) Octocrylene (20 g) Oxybenzone
Inactive Ingredients
Water Glycolic Acid Glycerin Ammonia Cetyl Alcohol Methyl Methacrylate/glycol Dimethacrylate Crosspolymer Glyceryl Monostearate Potassium Cetyl Phosphate Dimethicone Hydrogenated Palm Glycerides Allantoin Butylene Glycol Ethylhexylglycerin Phenoxyethanol Panthenol .alpha.-tocopherol Acetate, Dl- Bentonite Xanthan Gum Camellia Oleifera Leaf Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-10-01

Description

Drug Facts

Purpose

Sunscreen ” ” ” ”


Medication Information

Purpose

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 51945-4

Principal Display Panel - Skin+Pharmacy Advanced Anti-Aging Therapy Carton Label

SKIN+PHARMACY

ADVANCED ANTI-AGING THERAPY

GLYCOLIC DAY MOISTURIZER

with Microsponge® Technology

Brightening Formula with

SPF 30 Broad Spectrum Screen

  • smoothing formula protects skin from harmful UVA & UVB rays
  • helps improve the appearance of skin's tone & texture
  • fragrance- & oil-free formula

exclusively at

CVS/pharmacy

DERMATOLOGIST TESTED

Actual Size Product on Side Panel

1 FL OZ (30 mL)

Warnings

For external use only.

  • Do not use on damaged or broken skin
  • Stop use and ask a doctor if rash occurs
  • When using this product keep out of eyes. Rinse with water to remove.
Directions
  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • Children under 6 months: Ask a doctor
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • -
      limit time in the sun, especially from 10 a.m.-2 p.m.
    • -
      wear long-sleeved shirts, pants, hats and sunglasses
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 5.0%

Inactive Ingredients

Water, Glycolic Acid, Glycerin, Ammonium Hydroxide, Cetyl Alcohol, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Glyceryl Stearate, Potassium Cetyl Phosphate, Methyl Glucose Sesquistearate, Dimethicone, Phenoxyethanol, Butylene Glycol, Hydrogenated Palm Glycerides, Xanthan Gum, Camellia Oleifera Leaf Extract, Panthenol, Tocopheryl Acetate, Bentonite, Disodium EDTA, Allantoin, Ethylhexylglycerin.

Microsponge® is a registered trademark of AMCOL International Corp.

Save carton for complete labeling.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2014 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

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

V-31490

CVS® Quality

Money Back Guarantee

#979862

M050778CP

FP103


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 51945-4 (51945-4)

Principal Display Panel - Skin+Pharmacy Advanced Anti-Aging Therapy Carton Label

SKIN+PHARMACY

ADVANCED ANTI-AGING THERAPY

GLYCOLIC DAY MOISTURIZER

with Microsponge® Technology

Brightening Formula with

SPF 30 Broad Spectrum Screen

  • smoothing formula protects skin from harmful UVA & UVB rays
  • helps improve the appearance of skin's tone & texture
  • fragrance- & oil-free formula

exclusively at

CVS/pharmacy

DERMATOLOGIST TESTED

Actual Size Product on Side Panel

1 FL OZ (30 mL)

Purpose

Sunscreen

Warnings

For external use only.

  • Do not use on damaged or broken skin
  • Stop use and ask a doctor if rash occurs
  • When using this product keep out of eyes. Rinse with water to remove.
Directions
  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • Children under 6 months: Ask a doctor
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • -
      limit time in the sun, especially from 10 a.m.-2 p.m.
    • -
      wear long-sleeved shirts, pants, hats and sunglasses
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 5.0%

Inactive Ingredients (Inactive ingredients)

Water, Glycolic Acid, Glycerin, Ammonium Hydroxide, Cetyl Alcohol, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Glyceryl Stearate, Potassium Cetyl Phosphate, Methyl Glucose Sesquistearate, Dimethicone, Phenoxyethanol, Butylene Glycol, Hydrogenated Palm Glycerides, Xanthan Gum, Camellia Oleifera Leaf Extract, Panthenol, Tocopheryl Acetate, Bentonite, Disodium EDTA, Allantoin, Ethylhexylglycerin.

Microsponge® is a registered trademark of AMCOL International Corp.

Save carton for complete labeling.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2014 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

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

V-31490

CVS® Quality

Money Back Guarantee

#979862

M050778CP

FP103


Advanced Ingredient Data


Raw Label Data

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