Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 59b05c6d-2e35-4943-8269-c31c74dfd479
Route
TOPICAL
Published
Effective Date 2017-03-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (40 mg) Octisalate (20 mg) Avobenzone Octocrylene
Inactive Ingredients
Water Styrene/acrylamide Copolymer (mw 500000) Glycerin Dimethicone Isononyl Isononanoate Trisiloxane Steareth-21 Pentylene Glycol Cetyl Alcohol Phenoxyethanol Silicon Dioxide Methyl Methacrylate/glycol Dimethacrylate Crosspolymer Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked) Steareth-2 Peg-100 Stearate Glyceryl Monostearate Polysorbate 20 Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Chlorphenesin Retinol Xanthan Gum Butylated Hydroxytoluene Ethylhexylglycerin Edetate Disodium Nylon-12 Sodium Hydroxide Myrtus Communis Leaf Stearyl Alcohol .alpha.-tocopherol Acetate Hyaluronate Sodium Propyl Gallate Ascorbic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-04-01

Description

Avobenzone 2.0% Homosalate 4.0% Octisalate 4.0% Octocrylene 2.0%

Purpose

Sunscreen Sunscreen Sunscreen Sunscreen


Medication Information

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Description

Avobenzone 2.0% Homosalate 4.0% Octisalate 4.0% Octocrylene 2.0%

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 2.0%

Homosalate 4.0%

Octisalate 4.0%

Octocrylene 2.0%

Inactive Ingredients

Water, Styrene/Acrylates Copolymer, Glycerin, Dimethicone, Isononyl Isononanoate, Trisiloxane, Steareth-21, Pentylene Glycol, Cetyl Alcohol, Phenoxyethanol, Silica, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Steareth-2, PEG-100 Stearate, Glyceryl Stearate, Polysorbate 20, Dimethicone/Vinyl Dimethicone Crosspolymer, Chlorphenesin, Retinol, Xanthan Gum, BHT, Ethylhexylglycerin, Disodium EDTA, Nylon-12, Sodium Hydroxide, Hydrolyzed Myrtus Communis Leaf Extract, Stearyl Alcohol, Tocopheryl Acetate, Sodium Hyaluronate, Propyl Gallate, Ascorbic Acid, Fragrance

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 foreign components

V-13649

CVS ® Quality

Money Back Guarantee

M050891

FP121

Principal Display Panel Bottle Label

beauty

360™

ACCELERATED

WRINKLE

REPAIR


MOISTURIZER

MEASURABLE RESULTS

Rapid retinol SR

Formulated without parabens

BROAD SPECTRUM

SPF 30 SUNSCREEN

SPF

30

1 FL OZ (29 mL)

Principal Display Panel Carton Label

ACCELERATED

WRINKLE

REPAIR


MOISTURIZER

MEASURABLE

RESULTS

Rapid retinol SR

Formulated without

parabens

UVA/UVB protection

BROAD SPECTRUM

SPF 30 SUNSCREEN

SPF

30

COMPARE TO

NEUTROGENA®

RAPID WRINKLE

REPAIR

MOISTURIZER*

CVS

pharmacy
®

1 FL OZ

(29 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

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 2.0%

Homosalate 4.0%

Octisalate 4.0%

Octocrylene 2.0%

Inactive Ingredients (Inactive ingredients)

Water, Styrene/Acrylates Copolymer, Glycerin, Dimethicone, Isononyl Isononanoate, Trisiloxane, Steareth-21, Pentylene Glycol, Cetyl Alcohol, Phenoxyethanol, Silica, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Steareth-2, PEG-100 Stearate, Glyceryl Stearate, Polysorbate 20, Dimethicone/Vinyl Dimethicone Crosspolymer, Chlorphenesin, Retinol, Xanthan Gum, BHT, Ethylhexylglycerin, Disodium EDTA, Nylon-12, Sodium Hydroxide, Hydrolyzed Myrtus Communis Leaf Extract, Stearyl Alcohol, Tocopheryl Acetate, Sodium Hyaluronate, Propyl Gallate, Ascorbic Acid, Fragrance

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 foreign components

V-13649

CVS ® Quality

Money Back Guarantee

M050891

FP121

Principal Display Panel Bottle Label (Principal Display Panel - Bottle Label)

beauty

360™

ACCELERATED

WRINKLE

REPAIR


MOISTURIZER

MEASURABLE RESULTS

Rapid retinol SR

Formulated without parabens

BROAD SPECTRUM

SPF 30 SUNSCREEN

SPF

30

1 FL OZ (29 mL)

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

ACCELERATED

WRINKLE

REPAIR


MOISTURIZER

MEASURABLE

RESULTS

Rapid retinol SR

Formulated without

parabens

UVA/UVB protection

BROAD SPECTRUM

SPF 30 SUNSCREEN

SPF

30

COMPARE TO

NEUTROGENA®

RAPID WRINKLE

REPAIR

MOISTURIZER*

CVS

pharmacy
®

1 FL OZ

(29 mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)