FDA.reportPublic FDA data

Glycolic Day Cream SPF 30

Manufacturer
AMCOL Health and Beauty Solutions, Inc. | JKA Incorporated
Effective date
2010-02-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:23:33

Label at a glance#

ProductGlycolic Day Cream SPF 30
Active ingredientHomosalate, Octisalate, Octocrylene, Oxybenzone, Avobenzone
Label structure3 sections

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredients           Purpose

Homosalate 10.0% . . . . . Sunscreen

Octisalate 5.0% . . . . . . .  Sunscreen

Oxybenzone  5.0% . . . . .Sunscreen

Avobenzone  3.0% . . . .Sunscreen

Octocrylene  2.0% . . . . Sunscreen

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.  Do not swallow.  If swallowed, get medical help or contact a Posion Control Center right away.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FP103boxdisplayFP103boxdisplay

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68634-0032-22019-10-21C16284748780-1956f9ecf-d9e0-621f-e053-dbdaa90a74adGlycolic Day Cream SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68634-0032-1Glycolic Day Cream SPF 3030 mL in 1 JARCREAM301
68634-0032-2Glycolic Day Cream SPF 301 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68634-0032GLYCOLIC DAY CREAM SPF 30 (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AVOBENZONE) CREAM [AMCOL HEALTH AND BEAUTY SOLUTIONS, INC.]1Legacy NDC, 2 package rows20100205_cf473fce-9831-4e48-bfc4-e8f8bdd6663b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOX1
HomosalateACTIVE INGREDIENTV06SV4M95S1
OctisalateACTIVE INGREDIENT4X49Y0596W1
OctocryleneACTIVE INGREDIENT5A68WGF6WM1
OxybenzoneACTIVE INGREDIENT95OOS7VE0Y1
AvobenzoneACTIVE MOIETYG63QQF2NOX1
HomosalateACTIVE MOIETYV06SV4M95S1
OctisalateACTIVE MOIETY4X49Y0596W1
OctocryleneACTIVE MOIETY5A68WGF6WM1
OxybenzoneACTIVE MOIETY95OOS7VE0Y1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68634-003268634-0032-1, 68634-0032-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
HomosalateV06SV4M95SACTIB
Octisalate4X49Y0596WACTIB
Octocrylene5A68WGF6WMACTIB
Oxybenzone95OOS7VE0YACTIB
AvobenzoneG63QQF2NOXACTIB

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
e8bc0518-5921-4505-99fc-b8c4f30b58c6cf473fce-9831-4e48-bfc4-e8f8bdd6663b2010-02-04Exact identifier
spl id: e8bc0518-5921-4505-99fc-b8c4f30b58c6
spl set id: cf473fce-9831-4e48-bfc4-e8f8bdd6663b

Reported adverse events (FAERS/openFDA)#

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