FDA.reportPublic FDA data

Bronzing Blendrops Broad Spectrum SPF 40

Product NDC
44717-082
11-digit product format
447170082
Labeler code
44717
Product ID
44717-082_458ade5c-87cd-13ee-e063-6294a90a006b
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Octisalate, Zinc Oxide
Dosage form
SOLUTION/ DROPS
Route
TOPICAL
Labeler
Wasatch Product Development, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-02
Marketing end
2027-02-28
Substance
HOMOSALATE; OCTISALATE; ZINC OXIDE
Active strength
6; 5; 12 g/100mL; g/100mL; g/100mL
NDC exclude flag
No
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
Bronzing Blendrops Broad Spectrum SPF 40

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE6 g/100mL
OCTISALATE5 g/100mL
ZINC OXIDE12 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
124ca946-8412-4d6d-e063-6294a90a6338Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8234c772-5c41-424c-a33e-e06e8c4de9c1Product name220250626
fbe2ea47-480e-f5f1-0d64-c87fd5ac923bProduct name420250224
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
510b43a3-8143-a25f-19c6-476c90dbb618Product name920171115
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44717-082-01Bronzing Blendrops Broad Spectrum SPF 4030 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44717-082BRONZING BLENDROPS BROAD SPECTRUM SPF 40 (HOMOSALATE, OCTISALATE, ZINC OXIDE) SOLUTION/ DROPS [WASATCH PRODUCT DEVELOPMENT, LLC]1Current NDC, 1 package rows20240228_124ca946-8412-4d6d-e063-6294a90a6338.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 281 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fruit of the Earth Sun Town City SPF 15 SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.c7aaa185-8490-60ec-e053-2995a90adc0d2024-10-17WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Dark Tanning SPF 8 SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.c7aa1e58-f7b3-6b7f-e053-2995a90a957c2024-10-17WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.c7bbad46-5c52-9f1d-e053-2995a90ae1392024-10-17WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Baby SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.c7bdd7a3-2e88-d881-e053-2a95a90a2ef92024-10-17WarningsExact identifier
application number: M020
dermalogica dynamic skin recovery spf 50SUNSCREENDermalogica, LLC051b77ab-6970-48e4-bbfd-c066178ea32e2024-10-17WarningsExact identifier
application number: M020
Hyaluronic MoisturizerOCTINOXATE, OXYBENZONE. AVOBENZONEBentley Laboratories LLC88bd6dff-ba19-4f8f-9432-28398d24f1ab2024-10-16WarningsExact identifier
application number: M020
EQUALINE SPORT CONTINUOUS SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEUnited Natural Foods, Inc. dba UNFIf13feba4-25d8-61d0-e053-2995a90aafa82024-10-16WarningsExact identifier
application number: M020
Equaline Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENEUnited Natural Foods, Inc. dba UNFIf0dda684-b0ed-629c-e053-2995a90a12872024-10-16WarningsExact identifier
application number: M020
EQUALINE SPORT SUNSCREEN CONTINUOUS SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEUnited Natural Foods, Inc. dba UNFIe46d20b3-2897-1370-e053-2a95a90a619c2024-10-16WarningsExact identifier
application number: M020
MEIJER BROAD SPECTRUM SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISLATE, OCTOCRYLENEMEIJER DISTRIBUTION. INC.a71d34d4-a924-6421-e053-2995a90a647e2024-10-16WarningsExact identifier
application number: M020
MEIJER BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEMEIJER DISTRIBUTION, INC.a71bf24f-b923-b81f-e053-2995a90a00722024-10-16WarningsExact identifier
application number: M020
MEIJER KIDS BROAD SPECTRUM SPF 50 MINERAL BASED SUNSCREENOCTINOXATE, OCTISALATE, ZINC OXIDEMEIJER DISTRIBUTION INCa9f4fd45-3bbb-14a7-e053-2995a90ab28f2024-10-16WarningsExact identifier
application number: M020
WEGMANS SPORT CLEAR CONTINUOUS SUNSCREEN SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWEGMANS FOOD MARKETS INCe4b7df52-2bc9-1afc-e053-2a95a90a4f872024-10-16WarningsExact identifier
application number: M020
Wegmans SPORT BROAD SPECTRUM SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWEGMANS FOOD MARKETS INCf12bff9a-bd3c-e35d-e053-2995a90abf172024-10-16WarningsExact identifier
application number: M020
MINERAL SUNSCREEN SPF 50ZINC OXIDE, TITANIUM DIOXIDEWEGMANS FOOD MARKETS INCbfe24f55-d0e5-254a-e053-2995a90a2fd32024-10-16WarningsExact identifier
application number: M020
Wegmans Sport Broad Spectrum SPF 70 Clear Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENEWEGMANS FOOD MARKETS INCe7175821-e514-1bea-e053-2995a90a0c0d2024-10-16WarningsExact identifier
application number: M020
Wegmans Kids and Sport Broad Spectrum SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWEGMANS FOOD MARKETS INCf3463f81-9a65-3796-e053-2995a90a4f802024-10-16WarningsExact identifier
application number: M020
Wegmans Sheer Broad Spectrum SPF 30 Dry Touch SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWEGMANS FOOD MARKETS INCf33248fa-695a-fbef-e053-2a95a90abe352024-10-16WarningsExact identifier
application number: M020
Wegmans Sport Sunscreen Stick SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWEGMANS FOOD MARKETS INCf5671251-e26b-045f-e053-2a95a90adc032024-10-16WarningsExact identifier
application number: M020
Wegmans Kids Sunscreen Stick SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWEGMANS FOOD MARKETS INCf57775c3-5e6c-f47a-e053-2a95a90ab0122024-10-16WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44717-082-014471700820130 mL in 1 BOTTLE, PLASTIC (44717-082-01) 30 ml2024-02-022027-02-28NoNoHistorical