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 104 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
THE MELT MIST Sheerest Mineral Mist Suncare for BodyTITANIUM DIOXIDE, ZINC OXIDEDune Suncare, Inc.465d3277-7798-512a-e063-6294a90a20652025-12-20WarningsExact identifier
application number: M020
THE SLIP Invisible Cooling Suncare for Face and BodyAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEDune Suncare, Inc.465e1ba2-e967-edb9-e063-6294a90aa31c2025-12-20WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 9NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior7287078e-67ff-41fe-bc8d-59b2146f5dc92025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2WOOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb6095639-e2ee-418e-b4f1-e59da1bd92162025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior8c6466a6-4f11-4210-bb02-eb31c15984cd2025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior07f8282b-047b-4be1-8779-39ed5dd6fb5d2025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2CROCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5a8c67c1-aeba-490d-8347-a30916efcf3b2025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior739450b0-8cd7-41de-8cd0-1827e02478c62025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior08b0e056-583a-474b-aaaa-ecea057030442025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2.5WOCTISALATE, TITANIUM DIOXIDEParfums Christian Diora89af40e-cf45-4afc-aac7-5f71a05bcd3f2025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6da72e20-f2d7-492e-9b65-b5ac73bc00292025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1CROCTISALATE, TITANIUM DIOXIDEParfums Christian Diorde615c3e-669f-493c-9c75-73dfbe726c592025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior152790ba-aeda-4c2a-b725-7e040e8328832025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1.5WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5f5cd18a-04fa-4b53-b7e9-6b1e97acc61a2025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior54f7fe8d-aab4-4fab-b239-52c5e7ce7c0c2025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc87e5201-f7fd-4fd9-adeb-d6af9be00db62025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0CROCTISALATE, TITANIUM DIOXIDEParfums Christian Dior84cdaad2-5b7d-4841-bef6-ffad4fe6907a2025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 00OCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb4caa2bc-8118-4137-8834-25800f8e5e012025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc0fa32fe-faa7-4a47-906c-14db01e55d472025-12-19WarningsExact identifier
application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 8NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorff1a8b32-c01f-4910-9a7a-c74eb49c05a02025-12-19WarningsExact 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