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
OCTISALATE; AVOBENZONE; OCTINOXATE
Active strength
5; 3; 7.5 g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE5 g/100g
AVOBENZONE3 g/100g
OCTINOXATE7.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup
4Y5P7MUD51Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ea9db179-1b69-01e0-e053-2a95a90a1628Available on FDA.report

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

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 67 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHISEIDO SPORTS BB DARKOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONf4fc4b6a-9507-496e-9ecb-8400055ecf2d2026-01-28WarningsExact identifier
application number: M020
Hampton Sun SPF 30 MineralZINC OXIDE 7.20% TITANIUM DIOXIDE 4.00%S&C Hampton Sun LLCb8ee428e-07d3-4c6c-853c-cfbe3e4002d92026-01-28WarningsExact identifier
application number: M020
SHISEIDO FUTURE LX UNIVERSAL DEFENSE SOCTISALATE, OCTOCRYLENE, AND ZINC OXIDESHISEIDO AMERICAS CORPORATION0a6f8eef-48e9-44f5-9811-629bc0dc07d02026-01-28WarningsExact identifier
application number: M020
Hampton Sun SPF 45 Tinted FaceHOMOSALATE 10% OCTOCRYLENE 6% AVOBENZONE 3%S&C Hampton Sun LLC0fc0f2c7-ec0f-4976-9872-82a6bfe8b46b2026-01-28WarningsExact identifier
application number: M020
Walgreens 70 Sport SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY49775d1a-e573-a596-e063-6294a90a7cf62026-01-28WarningsExact identifier
application number: M020
AVON ANEW ULTIMATE MULTI-PERFORMANCE DAY BROAD SPECTRUM SPF 25 SUNSCREENAVOBENZONE, HOMOSALATE, OCTINOXATE, OXYBENZONEThe Avon Company49784430-2ffe-0cbb-e063-6394a90adb232026-01-28WarningsExact identifier
application number: M020
ALOE UP SPORT SPF-50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC3f2f90f1-28dd-48e8-9083-ea04815acc6b2026-01-28WarningsExact identifier
application number: M020
ALOE UP PRO 30 CONTINUOUS SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEAloe Care International, LLCbaf32d84-4db5-4ed0-9814-5470b7d1f4a42026-01-28WarningsExact identifier
application number: M020
ALOE UP PRO 15AVOBENZONE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC5b0f43fc-f4a6-4403-a40e-e0198a6f2ebd2026-01-28WarningsExact identifier
application number: M020
ALOE UP PRO 50 CONTINUOUS SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEAloe Care International, LLCdc33d9e8-3463-485d-a1ee-6319ed91454c2026-01-28WarningsExact identifier
application number: M020
ALOE ICE SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEAloe Care International, LLCe4b861d2-3680-4ed7-8650-d1d839da5ab22026-01-28WarningsExact identifier
application number: M020
ALOE UP SPORT SPF-15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC1bf1635a-825e-417f-97b4-4bce6d251d192026-01-28WarningsExact identifier
application number: M020
Mineral SunscreenZINC OXIDE 20%The Daily Suncare LLC, DBA Daily Shade1a392f6b-1bb1-c49d-e063-6294a90a791d2026-01-28WarningsExact identifier
application number: M020
KIZO LAB UV DEFENSE CLEAR SUNSCREN SPF50AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEYB CHEMIA LLC0053ae49-b9a1-c3f4-e063-6394a90abcb82026-01-28WarningsExact identifier
application number: M020
Orange GelAVOBENZONE OCTISALATE OCTOCRYLENE HOMOSALATEVacation Inc.132896ef-d6c6-4ec7-e063-6294a90a103b2026-01-28WarningsExact identifier
application number: M020
REDEFINE Triple DefenseAVOBENZONE, OCTISALATE, OCTOCRYLENERodan & Fieldsd1dd62c6-33ac-4941-ab99-9eb8cc3c208a2026-01-27WarningsExact identifier
application number: M020
Centellian24 Madeca Derma Shield Vital Airy Sun StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE7054144e11009-ffcb-dd59-e063-6294a90add222026-01-27WarningsExact identifier
application number: M020
Sunscreen SPF50NON NANO ZINC OXIDESBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESIc5d52f13-a649-9579-e053-2a95a90a062c2026-01-27WarningsExact identifier
application number: M020
ONSART Mineral Sunscreen SPF 50ZINC OXIDE 24%Guangzhou Huixue Biotechnology Co., Ltd.495e3266-a59f-42f7-e063-6394a90adfa32026-01-27WarningsExact identifier
application number: M020
Poolside Sun Daze Body Illuminator SPF 30 Shimmer SunscreenHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC54868d6f-ae4c-476d-8c77-c4a72b13d2ea2026-01-27WarningsExact identifier
application number: M020

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