FDA.reportPublic FDA data

SPF 50 Florida Sun Defense

Product NDC
84489-100
11-digit product format
844890100
Labeler code
84489
Product ID
84489-100_47c147a9-c4f5-ab82-e063-6394a90aaa5c
Type
HUMAN OTC DRUG
Nonproprietary name
homosalate, octisalate, octocrylene
Dosage form
OIL
Route
TOPICAL
Labeler
Naples Soap Company, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-03
Substance
OCTOCRYLENE; HOMOSALATE; OCTISALATE
Active strength
10; 10; 5 g/100mL; g/100mL; g/100mL
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
SPF 50 Florida Sun Defense
Brand name suffix
Broad Spectrum SPF 50 Sunscreen Body Oil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE10 g/100mL
HOMOSALATE10 g/100mL
OCTISALATE5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
47c147a9-c4f4-ab82-e063-6394a90aaa5cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84489-100-34SPF 50 Florida Sun DefenseBroad Spectrum SPF 50 Sunscreen Body Oil100 mL in 1 BOTTLE, PUMPOIL1001
84489-100-34SPF 50 Florida Sun DefenseBroad Spectrum SPF 50 Sunscreen Body Oil1 in 1 CARTONOIL11

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 184 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PUR 4-in-1 Skin Tint MN3ZINC OXIDEPUR Minerals3f06df49-5ed2-44ca-e063-6294a90a1fda2025-09-24WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint LN2ZINC OXIDEPUR Minerals3f069dfe-289d-8d3b-e063-6394a90a04962025-09-24WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint LG3ZINC OXIDEPUR Minerals3f06ec3e-fc15-9f7b-e063-6394a90a07332025-09-24WarningsExact identifier
application number: M020
Volition Prismatic Luminizing ShieldZINC OXIDEVolition1a633c24-b9d9-4732-e063-6294a90af4c02025-09-24WarningsExact identifier
application number: M020
Alleyoop Sunsational Broad SpectrumZINC OXIDENewAlley Innovations Inc248419c4-8044-402c-e063-6394a90a00f82025-09-24WarningsExact identifier
application number: M020
Aloe Up SPF 30 coco-mango mistAVOBENZONE 3.0%, HOMOSALATE 7.5%, OCTISALATE 5.0%Aloe Upf7b2d4a2-3a0d-4239-b7e5-8de2f6ac2e922025-09-24WarningsExact identifier
application number: M020
pavise Dynamic Age DefenseZINC OXIDEB.A.I BIOSCIENCES, INCf4e9f95c-6b1e-d5f7-e053-2a95a90a93ce2025-09-24WarningsExact identifier
application number: M020
Aloe Up SPF 50 coco-mango mistAVOBENZONE 3.0%, HOMOSALATE 10.0%, OCTISALATE 5.0%Aloe Upd535b711-c54e-4447-9907-ca9d829d13192025-09-24WarningsExact identifier
application number: M020
ESPOIR WATER SPLASH SUN SERUMHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEESPOIR Corporation1c4e7ba2-05e8-f949-e063-6394a90a699d2025-09-23WarningsExact identifier
application number: M020
Banana BoatZINC OXIDEEdgewell Personal Care Brands LLC1d11c3d0-5f4e-0ed0-e063-6294a90abc752025-09-23WarningsExact identifier
application number: M020
Dewscreen Daily Hydrator and Primer SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop LLC3f7c84e3-0e4f-b7e9-e063-6294a90a12952025-09-23WarningsExact identifier
application number: M020
Sun Bum Daily Gel Gel Sunscreen Moisturizer Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC15d8574d-94bb-4842-e063-6394a90a15e62025-09-23WarningsExact identifier
application number: M020
Sun Bum Daily BodyAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC15da0cb1-e695-cec3-e063-6394a90a1afa2025-09-23WarningsExact identifier
application number: M020
Sun Bum Daily Face Liquid Sunscreen Moisturizer Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC15daac41-54b6-096d-e063-6294a90a07362025-09-23WarningsExact identifier
application number: M020
Mtn. Bum by Sun Bum and Mcfetridge Mineral Sunscreen Face Stick SPF 50ZINC OXIDESun Bum, LLC3f8101b1-297d-2ad8-e063-6294a90a9cff2025-09-23WarningsExact identifier
application number: M020
Sun Bum Daily Glow Tinted Sunscreen Moisturizer Broad Spectrum SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENESun Bum, LLC20c48752-3ad9-5993-e063-6294a90ae1b02025-09-23WarningsExact identifier
application number: M020
CVS SPF 60 Face SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS26d1b568-ad9c-80d7-e063-6394a90a2cbf2025-09-21WarningsExact identifier
application number: M020
Radiant Shield Tinted Mineral Sunscreen SPF 40ZINC OXIDECosMedical Technologies, LLCf229b928-49fd-4e02-99c1-b2cd9166894f2025-09-19WarningsExact identifier
application number: M020
EquateDaytimeFaceLotionEQUATE DAYTIME FACE LOTION WITH SUNSCREEN, SPF 30, 3 OZWalmart Inc.2efc7087-f4ad-2f2e-e063-6394a90a13022025-09-18WarningsExact identifier
application number: M020
ERBORIAN CC RED CORRECTERBORIAN CC RED CORRECT SPF 25- OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE CREAMKolmask Co., Ld.09ca2d4b-e0c2-9961-e063-6394a90aa82e2025-09-18Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84489-100-34844890100341 BOTTLE, PUMP in 1 CARTON (84489-100-34) / 100 mL in 1 BOTTLE, PUMP2025-07-03NoNoCurrent