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 228 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COOLA Classic Body SPF 50 Fragrance FreeAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCed207afe-0b10-74c7-e053-2a95a90a9b872025-02-17WarningsExact identifier
application number: M020
Avon Skin-So-Soft Bug Guard plus SPF 30 Sunscreen Gentle Breeze Insect Repellent SunscreenOCTINOXATE, OXYBENZONE, OCTISALATEThe Avon Company2e5d6c93-f091-5388-e063-6394a90ad5602025-02-17WarningsExact identifier
application number: M020
KEYS SOULCARE DAILY MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc31a98dc7-4b99-d845-e063-6394a90a26702025-02-17WarningsExact identifier
application number: M020
Ultra sheer mineral sunscreen PRO SPF30ZINC OXIDEEden Brands Inc.2ce06566-2eb0-9a00-e063-6394a90a9ba92025-02-14WarningsExact identifier
application number: M020
Cell Fusion C Laser UV Defense Sunscreen Broad Spectrum SPF 50HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDECMS LAB Inc.2dff0386-e151-089a-e063-6394a90a0f532025-02-14WarningsExact identifier
application number: M020
Cell Fusion C Airy Stick Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECMS LAB Inc.2dffc699-3b56-2c70-e063-6294a90ae2492025-02-14WarningsExact identifier
application number: M020
Sun Defense Minerals (Sheer)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e2082aa-5ae3-2c04-e063-6294a90a140b2025-02-14WarningsExact identifier
application number: M020
Coola SPF 30 Mineral Sunscreen Fragrance FreeZINC OXIDECOOLA, LLCedc6048e-0ea0-41c5-e053-2a95a90a96d92025-02-14WarningsExact identifier
application number: M020
COOLA Classic Body SPF 50 Guava MangoAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCed13afaa-35ec-8326-e053-2995a90adaf02025-02-14WarningsExact identifier
application number: M020
Sun Defense Minerals (Light)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e21f5bb-e7df-b43b-e063-6394a90a0f822025-02-14WarningsExact identifier
application number: M020
Sun Defense Minerals (Fair)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e2102c6-02ea-3a8f-e063-6394a90abf5e2025-02-14WarningsExact identifier
application number: M020
Sunscreen Broad Spectrum SPF 50 Vi AestheticsZINC OXIDE, OCTINOXATEVi Medical Products, INC73620765-c7c0-4bd7-82a9-00022773c9282025-02-14WarningsExact identifier
application number: M020
Sun Defense Minerals (Medium)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e2297d4-3649-a749-e063-6294a90ac2842025-02-14WarningsExact identifier
application number: M020
Sun Defense Minerals (Light)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e22cfde-10a1-3742-e063-6394a90ac0972025-02-14WarningsExact identifier
application number: M020
Cell Fusion C Derma UV Mineral Sunscreen Broad Spectrum SPF 50HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDECMS LAB Inc.2e5c2add-8ed0-a990-e063-6394a90a87ea2025-02-14WarningsExact identifier
application number: M020
Les Duets - Shield of Helios, sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED385f75a5-6a3b-a129-e063-6394a90a52a02025-02-14WarningsExact identifier
application number: M020
Le Mieux Naked Glow Bronzer SPF 50SUNSCREENYB CHEMIA LLC46465db7-c1f0-6980-e063-6294a90a3ed82025-02-14WarningsExact identifier
application number: M020
Sheer Tint Mineral SPF Serum - Light LightZINC OXIDEMineral Fusion brandsac6fdc35-82f8-4805-875e-2aa91aedec6f2025-02-14WarningsExact identifier
application number: M020
Fre Protect Me Lightweight Daily Moisturizer SPF 50ZINC OXIDEPeer Pharm Ltd.3989eebc-7262-4cda-84a1-ca30b638b7722025-02-13WarningsExact identifier
application number: M020
Fre Protect Me Lightweight Daily Moisturizer SPF 30ZINC OXIDEPeer Pharm Ltd.8ee9f97b-9081-4e0c-aa7a-27a31cbee17a2025-02-13WarningsExact 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