FDA.reportPublic FDA data

Skin Pharmacy Advanced Sun Therapy Broad Spectrum SPF 30 Sun

Manufacturer
AMCOL Health & Beauty Solutions, Inc. DBA
Effective date
2016-03-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:45:35

Label at a glance#

ProductSkin Pharmacy Advanced Sun Therapy Broad Spectrum SPF 30 Sun
Active ingredientHomosalate, Octisalate, Avobenzone, Oxybenzone, Octocrylene
Label structure10 sections

Indications and 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.

Dosage and administration

Apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%

Homosalate 4.0%

Octisalate 4.0%

Octocrylene 2.0%

Oxybenzone 3.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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.

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 SAFETY INFORMATION

  • Protect the product in this container from excessive heat and direct sunlight.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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
CVS® Quality
Money Back Guarantee
M050899CP FP100

________________________________________________________

end of text

160225

AMCOL Health & Beauty Solutions, Inc. DBA AMCOL Household and Personal Care

301 Laser Lane Lafayette, LA 70507 | www.amcolhpc.com

lauren.haase@amcol.com

Principal Display Panel - Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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)

Principal Display Panel - Carton Label
Principal Display Panel - Carton Label

Principal Display Panel - Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 - Tube Label
Principal Display Panel - Tube Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68634-052-012020-01-31C16284748780-19d75b9d0-fc3a-f424-e053-dadaa90a57ceb7f927af-d7fb-46ca-99e7-460dd26dd2b3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68634-052-01Skin Pharmacy Advanced Sun Therapy Broad Spectrum SPF 30 Sun180 mL in 1 TUBELIQUID1801
68634-052-01Skin Pharmacy Advanced Sun Therapy Broad Spectrum SPF 30 Sun1 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68634-052SKIN PHARMACY ADVANCED SUN THERAPY BROAD SPECTRUM SPF 30 SUN (HOMOSALATE, OCTISALATE, AVOBENZONE, OXYBENZONE, OCTOCRYLENE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA]1Legacy NDC, 2 package rows20160401_b7f927af-d7fb-46ca-99e7-460dd26dd2b3.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68634-05268634-052-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
HomosalateV06SV4M95SACTIB
Octisalate4X49Y0596WACTIB
AvobenzoneG63QQF2NOXACTIB
Oxybenzone95OOS7VE0YACTIB
Octocrylene5A68WGF6WMACTIB
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
SODIUM CETOSTEARYL SULFATE7ZBS06BH4BIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIMETHICONE92RU3N3Y1OIACT
PHENOXYETHANOLHIE492ZZ3TIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
BENTONITEA3N5ZCN45CIACT
CHLORPHENESINI670DAL4SZIACT
PICEA ABIES WOOD72GZ8K8996IACT
ALOE VERA LEAFZY81Z83H0XIACT
SODIUM HYDROXIDE55X04QC32IIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
TOCOPHEROLR0ZB2556P8IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4cc888dc-5eb7-4313-ae9b-90352d5c1f90b7f927af-d7fb-46ca-99e7-460dd26dd2b32016-03-08WarningsExact identifier
spl id: 4cc888dc-5eb7-4313-ae9b-90352d5c1f90
spl set id: b7f927af-d7fb-46ca-99e7-460dd26dd2b3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.