FDA.reportPublic FDA data

Berkley Jensen Sport Sunscreen SPF 50

Product NDC
68391-002
11-digit product format
683910002
Labeler code
68391
Product ID
68391-002_2503e883-3766-8455-e063-6394a90ac660
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
SPRAY
Route
TOPICAL
Labeler
BJWC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-02-20
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30; 100; 50; 40 mg/g; mg/g; mg/g; mg/g
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
Berkley Jensen Sport Sunscreen SPF 50
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/g
HOMOSALATE100 mg/g
OCTISALATE50 mg/g
OCTOCRYLENE40 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal 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
fbd65277-7aff-de19-e053-6394a90a9496Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68391-002-48Berkley Jensen Sport Sunscreen SPF 50258 g in 1 CANSPRAY2583
68391-002-78Berkley Jensen Sport Sunscreen SPF 502 in 1 PACKAGESPRAY23
68391-002-86Berkley Jensen Sport Sunscreen SPF 50207 g in 1 CANSPRAY2073
68391-002-97Berkley Jensen Sport Sunscreen SPF 503 in 1 PACKAGESPRAY33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-002BERKLEY JENSEN SPORT SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [BJWC]3Current NDC, 4 package rows20241023_fbd65277-7aff-de19-e053-6394a90a9496.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 160 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 31NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c77b48-18fb-3efe-e063-6294a90ade4b2025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 33NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c784ce-3a54-5416-e063-6294a90ac9a22025-11-17WarningsExact identifier
application number: M020
Daily Essential Face MoisturizerZINC OXIDESolarium Brands LLC2a92edc1-04ac-3eda-e063-6294a90ad46d2025-11-17WarningsExact identifier
application number: M020
Daily Essential Eye CreamTITANIUM DIOXIDE, ZINC OXIDESolarium Brands LLC2a931d9f-4ba8-e3a5-e063-6294a90af7802025-11-17WarningsExact identifier
application number: M020
Daily Essential Lip Oil Blushing NudeZINC OXIDESolarium Brands LLC2a93998c-185b-9207-e063-6294a90ab0e92025-11-17WarningsExact identifier
application number: M020
Solarium Daily Essentials Skin Perfecting PrimerZINC OXIDESolarium Brands LLC302a02d1-3dc5-2745-e063-6394a90ab6d22025-11-17WarningsExact identifier
application number: M020
Solarium Daily Essentials Luminizing Glow DropsZINC OXIDESolarium Brands LLC302a4efe-d429-b1c4-e063-6294a90a073d2025-11-17WarningsExact identifier
application number: M020
Daily Essential Lip Oil Dusty RoseZINC OXIDESolarium Brands LLC2a934860-02a7-a463-e063-6294a90aa4462025-11-17WarningsExact identifier
application number: M020
Daily Essential Lip Oil Scarlet BloomZINC OXIDESolarium Brands LLC2a931e78-e58c-e216-e063-6294a90a3e492025-11-17WarningsExact identifier
application number: M020
Morning Person Daily Repair Protect MoisturizerZINC OXIDEMorning Person Beauty33a20264-9216-154e-e063-6294a90a3c8b2025-11-17WarningsExact identifier
application number: M020
Banana Boat Baby Mineral Enriched Sunscreen UVA/UVB Protection Broad Spectrum SPF 50PLUSHOMOSALATE,OCTISALATE,OCTOCRYLENE,ZINC OXIDEEdgewell Personal Care Brands LLCc780d5cf-8388-42e0-e053-2a95a90a7c042025-11-17WarningsExact identifier
application number: M020
Hell on Earth The Resistance Daily Face MoisturizerTITANIUM DIOXIDE, ZINC OXIDEHell on Earth38debebf-1e12-09f3-e063-6294a90a9a2a2025-11-17WarningsExact identifier
application number: M020
BANANA BOAT PROTECTION PLUS VITAMINS FACE SUNSCREEN UVA/UVB BROAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLCe64de59e-b8db-522e-e053-2a95a90ac4582025-11-17WarningsExact identifier
application number: M020
Credo Skin Solar Limits SerumZINC OXIDEEco-Chic LLC395dc8eb-978b-a18f-e063-6294a90a22072025-11-17WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC05ce5223-3fb2-4c27-e063-6394a90a8a8f2025-11-17WarningsExact identifier
application number: M020
Credo Follain Daily Mineral SunscreenZINC OXIDEEco-Chic LLC395d6ad4-04ae-8945-e063-6294a90ad87c2025-11-17WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC0c7b7571-7317-98bc-e063-6294a90aa29f2025-11-17WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC22717885-d06b-ed2d-e063-6294a90a21182025-11-17WarningsExact identifier
application number: M020
Riversol Daily Glow Mineral TintedZINC OXIDERiversol Skincare3bc7d94e-e312-a9ca-e063-6394a90a43382025-11-17WarningsExact identifier
application number: M020
Riversol Daily Glow Mineral UntintedZINC OXIDERiversol Skincare3bc78cbb-83e3-7fd6-e063-6394a90a52602025-11-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68391-002-4868391000248258 g in 1 CAN258 gHistorical
68391-002-78683910002782 CAN in 1 PACKAGE (68391-002-78) / 258 g in 1 CAN (68391-002-48) 2 can2020-02-20NoNoCurrent
68391-002-8668391000286207 g in 1 CAN207 gHistorical
68391-002-97683910002973 CAN in 1 PACKAGE (68391-002-97) / 207 g in 1 CAN (68391-002-86) 3 can2020-02-20NoNoCurrent