FDA.reportPublic FDA data

FIRMARINE MOISTURIZER SPF 30

Product NDC
59735-480
11-digit product format
597350480
Labeler code
59735
Product ID
59735-480_4f84c202-6908-ec57-e063-6294a90a4890
Type
HUMAN OTC DRUG
Nonproprietary name
FIRMARINE MOISTURIZER SPF 30
Dosage form
CREAM
Route
TOPICAL
Labeler
PML NYC, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-04-10
Substance
AVOBENZONE; OCTINOXATE; OCTISALATE
Active strength
3; 7.5; 5 g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FIRMARINE MOISTURIZER SPF 30FIRMARINE MOISTURIZER SPF 30PML NYC, LLCea9db179-1b69-01e0-e053-2a95a90a16282026-04-15WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove.

Additional Listing Data#

Finished product
Yes
Brand name base
FIRMARINE MOISTURIZER SPF 30
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE3 g/100g
AVOBENZONE7.5 g/100g
OCTINOXATE5 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4X49Y0596W, G63QQF2NOX, 4Y5P7MUD51

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59735-480-012026-01-29C16284748780-149896155-a74d-586f-e063-e6dba90add90FIRMARINE MOISTURIZER SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59735-480-01FIRMARINE MOISTURIZER SPF 3050 g in 1 JARCREAM503
59735-480-01FIRMARINE MOISTURIZER SPF 301 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59735-480FIRMARINE MOISTURIZER SPF 30 CREAM [MANA PRODUCTS, INC.]2Current NDC, Legacy NDC, 2 package rows20240104_ea9db179-1b69-01e0-e053-2a95a90a1628.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59735-480-01597350480011 JAR in 1 CARTON (59735-480-01) / 50 g in 1 JAR1 jar2013-04-100000-00-00NoNoCurrent