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 180 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Wonderscreen Broad Spectrum SPF 30ZINC OXIDEWasatch Product Development, LLC.e895d942-e50e-1ad6-e053-2995a90a0e022025-10-10WarningsExact identifier
application number: M020
Illuminating SPF 50 plus drops Broad Spectrum SunscreenZINC OXIDECosmetic Enterprise Ltd13f40485-b98e-e804-e063-6394a90af2af2025-10-10WarningsExact identifier
application number: M020
Impeccable Skin Moisturizing Face Sunscreen Broad Spectrum SPF 30ZINC OXIDECosmetic Enterprises LTDa84d246b-1153-85ff-e053-2995a90a270a2025-10-10WarningsExact identifier
application number: M020
MediChoice Moisturizing Lip Balm SPF15AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEO&M HALYARD, INC.00327815-28f0-4198-bca7-c8ae768ff4162025-10-09WarningsExact identifier
application number: M020
Daybird 4-in-1 Skin Tint SerumZINC OXIDEResette, Inc.19c1a934-b0f5-1068-e063-6294a90a3b1f2025-10-09WarningsExact identifier
application number: M020
pavise Lip Defense tinted hydrating oil (hue 604)ZINC OXIDEB.A.I. Biosciences INC.f4ebbc1d-d521-1a47-e053-2a95a90a6f842025-10-09WarningsExact identifier
application number: M020
pavise Lip Defense tinted hydrating oil (hue 774)ZINC OXIDEB.A.I. Biosciences INC.f4ebd850-11a8-0d43-e053-2a95a90a2d342025-10-09WarningsExact identifier
application number: M020
pavise Lip Defense tinted hydrating oil (hue 616)ZINC OXIDEB.A.I. Biosciences INC.f4eb6b20-7c26-2942-e053-2a95a90abd312025-10-09WarningsExact identifier
application number: M020
Premium Moisturizing Sunscreen Broad Spectrum SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWasatch Product Development, LLCf4346f7a-3642-05d8-e053-2a95a90a013d2025-10-09WarningsExact identifier
application number: M020
Premium Moisturizing Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWasatch Product Development, LLCf4206dad-6a17-2f56-e053-2a95a90a69dc2025-10-09WarningsExact identifier
application number: M020
Premium Moisturizing Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWasatch Product Development, LLCf434089c-126f-441c-e053-2995a90ab0c72025-10-09WarningsExact identifier
application number: M020
BEAUTY SHIELD BROAD SPECTRUM SUNSCREEN (Napoleon Perdis)ZINC OXIDENapoleon PerdisCosmetic Pty Ltdbe64bb40-b1a9-2308-e053-2a95a90a69c82025-10-09WarningsExact identifier
application number: M020
Organys Open Formula SheerZINC OXIDEOrganys Beauty0b3ab551-cb66-cf86-e063-6394a90a7ab42025-10-09WarningsExact identifier
application number: M020
Dr Lift Mineral SPF 50TITANIUM DIOXIDE, ZINC OXIDESpa de Soleil40c03d65-8d09-371a-e063-6294a90a7ac62025-10-09WarningsExact identifier
application number: M020
Organys Derma Made SheerZINC OXIDEOrganys Beauty0b39f550-bd34-509d-e063-6294a90a51d02025-10-09WarningsExact identifier
application number: M020
Organys Derma MadeZINC OXIDEOrganys Beauty0b37a73b-73ca-501f-e063-6294a90a62912025-10-09WarningsExact identifier
application number: M020
Organys Derma MadeZINC OXIDEOrganys Beauty09b8b8c0-4066-9cbe-e063-6394a90aca242025-10-09WarningsExact identifier
application number: M020
Dr Lift Mineral SPF 30TITANIUM DIOXIDESpa de Soleil40c0e0d2-2c1d-e629-e063-6394a90a5aaf2025-10-09WarningsExact identifier
application number: M020
Daybird Tinted Skincare (SHADE 3)ZINC OXIDEResette, Incdc89ab76-da32-4f6f-e053-2995a90a8bcb2025-10-09WarningsExact identifier
application number: M020
Daybird Tinted Skincare (SHADE 4)ZINC OXIDEResette, Incdc89ab0b-d53e-983f-e053-2a95a90a127f2025-10-09WarningsExact 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