FDA.reportPublic FDA data

Sunsorb Reef Safe SPF50

Product NDC
65008-007
11-digit product format
650080007
Labeler code
65008
Product ID
65008-007_4354d16c-e4d4-d163-e063-6394a90aff83
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Zinc Oxide, Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
QS Key West Aloe, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-15
Substance
HOMOSALATE; ZINC OXIDE; OCTOCRYLENE
Active strength
100; 57; 50 mg/g; mg/g; mg/g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
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
Sunsorb Reef Safe SPF50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE100 mg/g
ZINC OXIDE57 mg/g
OCTOCRYLENE50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
SOI2LOH54ZInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b4fc7a51-a163-4057-8790-f2111668ec67Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65008-007-06Sunsorb Reef Safe SPF50170 g in 1 TUBELOTION1707

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65008-007SUNSORB REEF SAFE SPF50 (HOMOSALATE, ZINC OXIDE, OCTOCRYLENE) LOTION [QS KEY WEST ALOE, LLC]5Current NDC, Legacy NDC, 1 package rows20241210_b4fc7a51-a163-4057-8790-f2111668ec67.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 276 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Health 60 Plus Sensitive Skin SunTITANIUM DIOXIDE, ZINC OXIDECVS Pharmacy477c25ec-33db-04a6-e054-00144ff8d46c2024-10-22WarningsExact identifier
application number: M020
CVS Health SPF 70 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS Pharmacy4eb75945-9d65-55b4-e054-00144ff88e882024-10-22WarningsExact identifier
application number: M020
CVS Health Sport SPF 50 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE,CVS Pharmacy4ec6384a-8faf-5712-e054-00144ff8d46c2024-10-22WarningsExact identifier
application number: M020
CVS Health Sport SPF 30 ClearAVOBENZONE, HOMOSALATE, OCTOCRYLENE,CVS Pharmacy4ec6b50b-5236-6f5b-e054-00144ff8d46c2024-10-22WarningsExact identifier
application number: M020
CVS Pharmacy SPF 70 Beach Guard ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS Pharmacy4ec75d23-a33b-6c52-e054-00144ff88e882024-10-22WarningsExact identifier
application number: M020
CVS Health SPF 70 Beach Guard SunAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS Pharmacy4adbd66a-6b38-046d-e054-00144ff8d46c2024-10-22WarningsExact identifier
application number: M020
CVS Health Sport SPF 100 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS Pharmacy651c245c-2d3a-0019-e053-2991aa0a46372024-10-22WarningsExact identifier
application number: M020
CVS Health SPF 70 SunAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS Pharmacy63b420ba-ac69-5670-e053-2a91aa0a864b2024-10-22WarningsExact identifier
application number: M020
CVS Health Ultra Sheer SPF 100 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS PHARMACYc52a7e9b-5401-f6e7-e053-2995a90a95192024-10-22WarningsExact identifier
application number: M020
CVS Health Ultra Sheer Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS Pharmacyc68c3d6a-b656-abaf-e053-2a95a90a48db2024-10-22WarningsExact identifier
application number: M020
CVS Health Ultra Sheer Broad Spectrum SPF 45 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacyc5e8fcc9-db5c-9ee7-e053-2a95a90ac9402024-10-22WarningsExact identifier
application number: M020
CVS Health SPF 55 Ultra SheerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacyc617cdec-b489-22d2-e053-2995a90a1ec62024-10-22WarningsExact identifier
application number: M020
TRADER JOES ILLUMINATING DAILY FACIAL SUNSCREEN BROAD SPECTRUM SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETrader Joe's Company1b7c2f13-81b8-7af5-e063-6294a90a35012024-10-22WarningsExact identifier
application number: M020
CVS Health SPF 50 Beach GuardAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacydf25c35d-6b6d-1ef8-e053-2995a90aaef52024-10-22WarningsExact identifier
application number: M020
CVS Health Kids SPF 50 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYe4581d0e-ce6d-7898-e053-2a95a90a02b52024-10-22WarningsExact identifier
application number: M020
CVS Health SPF 55 Ultra Sheer Face MistAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacydfb55b46-e88f-4949-e053-2995a90adabc2024-10-22WarningsExact identifier
application number: M020
CVS Health Sport SPF 30 Clear Broad SpectrumAVOBENZONE, HOMOSALATE,OCTISALATE,OCTOCRYLENECVS PHARMACYe4589114-87c5-56b8-e053-2995a90a09342024-10-22WarningsExact identifier
application number: M020
TRADER JOES ENRICH MOISTURIZING FACE BROAD SPECTRUM SPF 15OCTINOXATE, ZINC OXIDETrader Joe's Companya6805675-916c-4a19-b993-d465fcef58a12024-10-22WarningsExact identifier
application number: M020
TRADER JOES FACE AND BODY SUNSCREEN SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETrader Joe's Company057ac99c-60e8-47c1-a32d-984bbd1818462024-10-22WarningsExact identifier
application number: M020
TRADER JOES ZINC OXIDE MINERAL SUNSCREEN SPF 30ZINC OXIDETrader Joe's Company9e48de83-cb72-4c03-a819-939db8793e1f2024-10-22WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65008-007-0665008000706170 g in 1 TUBE (65008-007-06) 170 g2019-07-150000-00-00NoNoCurrent