Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 0d36712d-9b27-4c11-b1e7-a810aae922da
Route
TOPICAL
Published
Effective Date 2017-03-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (100 mg) Octisalate (50 mg) Avobenzone (30 mg) Octocrylene (20 mg) 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

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

Purpose

Sunscreen ” ” ” ”


Medication Information

Purpose

Sunscreen

Description

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

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
  • 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

Principal Display Panel Jar Label

SKIN+PHARMACY

ADVANCED

ANTI-AGING THERAPY

GLYCOLIC DAY MOISTURIZER

with Microsponge
® Technology

Brightening Formula with

SPF 30 Broad Spectrum Sunscreen

Principal Display Panel 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)


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

Warnings

For external use only.

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

Principal Display Panel Jar Label (Principal Display Panel - Jar Label)

SKIN+PHARMACY

ADVANCED

ANTI-AGING THERAPY

GLYCOLIC DAY MOISTURIZER

with Microsponge
® Technology

Brightening Formula with

SPF 30 Broad Spectrum Sunscreen

Principal Display Panel Carton Label (Principal Display Panel - 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)


Advanced Ingredient Data


Raw Label Data

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