FDA.reportPublic FDA data

age renewal firming and hydrating moisturizer

Manufacturer
AMCOL Health and Beauty Solutions, Inc. | AMCOL Health and Beauty Soltuions, Inc.
Effective date
2010-02-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:23:34

Label at a glance#

Productage renewal firming and hydrating moisturizer
Active ingredientOctinoxate, Octisalate, Oxybenzone, Zinc Oxide
Label structure4 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:  Octinoxate 7.5%, Octisalate 5%, Oxybenzone 4%, Zinc Oxide 2%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FP104frontFP104front

GENERAL PRECAUTIONS SECTION

Caution:  For external use only.  Avoid getting into eyes.  If product gets into eyes, rinse thoroughly with water.  In the beginning you may experience mild tingling, warming, flaking and/or redness.  This is a sign that the product is working.  If discomfort occurs reduce use to every other day until your skin adjusts.  Discontinue use if irritation occurs.

OTC - STOP USE SECTION

Discontinue use if irritation occurs.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68634-0031-22019-10-21C16284748780-1956f9ecf-d4c7-621f-e053-dbdaa90a74adage renewal firming and hydrating moisturizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68634-0031-1age renewal firming and hydrating moisturizer51 g in 1 BOTTLE, GLASSCREAM511
68634-0031-2age renewal firming and hydrating moisturizer1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68634-0031AGE RENEWAL FIRMING AND HYDRATING MOISTURIZER (OCTINOXATE, OCTISALATE, OXYBENZONE, ZINC OXIDE) CREAM [AMCOL HEALTH AND BEAUTY SOLUTIONS, INC.]1Legacy NDC, 2 package rows20100216_7c1c1c4b-c91f-4c03-9026-feffa00ece33.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OctinoxateACTIVE INGREDIENT4Y5P7MUD511
OctisalateACTIVE INGREDIENT4X49Y0596W1
OxybenzoneACTIVE INGREDIENT95OOS7VE0Y1
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z1
OctinoxateACTIVE MOIETY4Y5P7MUD511
OctisalateACTIVE MOIETY4X49Y0596W1
OxybenzoneACTIVE MOIETY95OOS7VE0Y1
Zinc OxideACTIVE MOIETYSOI2LOH54Z1

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68634-003168634-0031-1, 68634-0031-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
Octinoxate4Y5P7MUD51ACTIB
Octisalate4X49Y0596WACTIB
Oxybenzone95OOS7VE0YACTIB
Zinc OxideSOI2LOH54ZACTIB

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
3d6d5909-5da6-4436-a39a-e7a3a2a3986e7c1c1c4b-c91f-4c03-9026-feffa00ece332010-02-15Exact identifier
spl id: 3d6d5909-5da6-4436-a39a-e7a3a2a3986e
spl set id: 7c1c1c4b-c91f-4c03-9026-feffa00ece33

Reported adverse events (FAERS/openFDA)#

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