FDA.reportPublic FDA data

BRUSH and GO SPF 50

Product NDC
78863-3003
11-digit product format
788633003
Labeler code
78863
Product ID
78863-3003_e93d10b6-0c2b-40a4-afe7-30b835988d75
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, and OXYBENZONE
Dosage form
POWDER
Route
TOPICAL
Labeler
Noon Aesthetics M.R. Ltd
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-01
Substance
TITANIUM DIOXIDE; OCTINOXATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE; OXYBENZONE
Active strength
.75; .141; .135; .08; .045; .045 g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL
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
BRUSH and GO SPF 50
Brand name suffix
ALL SKIN TYPES BROAD SPECTRUM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE.75 g/5mL
OCTINOXATE.141 g/5mL
OCTOCRYLENE.135 g/5mL
OCTISALATE.08 g/5mL
AVOBENZONE.045 g/5mL
OXYBENZONE.045 g/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup
95OOS7VE0YInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0d9f132c-7630-4261-a0f8-fc7a4377731fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78863-3003-1BRUSH and GO SPF 50 ALL SKIN TYPES BROAD SPECTRUM5 mL in 1 BOTTLE, PLASTICPOWDER52
78863-3003-1BRUSH and GO SPF 50 ALL SKIN TYPES BROAD SPECTRUM2 in 1 CARTONPOWDER22
78863-3003-2BRUSH and GO SPF 50 ALL SKIN TYPES BROAD SPECTRUM3 in 1 CARTONPOWDER32
78863-3003-2BRUSH and GO SPF 50 ALL SKIN TYPES BROAD SPECTRUM5 mL in 1 BOTTLE, PLASTICPOWDER52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78863-3003BRUSH AND GO SPF 50 ALL SKIN TYPES BROAD SPECTRUM (TITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONE) POWDER [NOON AESTHETICS M.R. LTD]1Current NDC, 4 package rows20240402_0d9f132c-7630-4261-a0f8-fc7a4377731f.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 271 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tenacious ErgodyneSPF 50 SUNSCREEN LOTIONTenacious Holdings, Inc.aaaa1f54-1136-4062-85ba-0926351580bb2024-10-23WarningsExact identifier
application number: M020
Bull Frog SPF 50 Quik with Water Armor TechAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBULLFROG BRANDS, LLC.f706f90c-eb79-2201-e053-6394a90a2ce42024-10-23WarningsExact identifier
application number: M020
Bull Frog SPF 50 Quik with Water Armor TechAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBULLFROG BRANDS, LLC.f70816a3-cc04-b000-e053-6294a90a0fae2024-10-23WarningsExact identifier
application number: M020
Alumier MD Post Procedure KitTITANIUM DIOXIDE, ZINC OXIDEAlumier Labs252859de-6676-5e07-e063-6394a90a64a12024-10-23WarningsExact identifier
application number: M020
Equate Sunscreen Tanning Oil With Coconut Oil SPF 6AVOBENZONE, HOMOSALATEWAL-MART STORES INC.f44d83d3-ffca-7a93-e053-2a95a90a77152024-10-23WarningsExact identifier
application number: M020
Tanning Sunscreen UVB Protection Dry Oil EquateAVOBENZONE, HOMOSALATE, OCTISALATEWAL-MART STORES INC.acdf62f2-742e-5df9-e053-2a95a90a96c52024-10-23WarningsExact identifier
application number: M020
WALMART EQUATE BEAUTY ULTRA LIGHT SUNSCREEN SPF 100AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEWAL-MART STORES INC.c8d4feca-7bee-2413-e053-2a95a90a739c2024-10-23WarningsExact identifier
application number: M020
Equate Sunscreen for All Skin Tones SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWal-Mart Stores Incf410ffcc-ef0e-13c4-e053-2a95a90a568a2024-10-23WarningsExact identifier
application number: M020
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 44NHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDERare Beauty, LLCcffbb6af-5a04-f58a-e053-2995a90a1ae22024-10-23WarningsExact identifier
application number: M020
Banana BoatTITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands, LLC441a46f0-ecda-4448-e054-00144ff88e882024-10-23WarningsExact identifier
application number: M020
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 28CHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDERare Beauty, LLCcffb8219-7076-de64-e053-2a95a90a60362024-10-23WarningsExact identifier
application number: M020
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 10NHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDERare Beauty, LLCcfee02eb-92f9-be12-e053-2a95a90a43372024-10-23WarningsExact identifier
application number: M020
CVS Pharmacy Kids SPF 70 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS Pharmacy4eb824a6-66ac-01f8-e054-00144ff8d46c2024-10-22WarningsExact identifier
application number: M020
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
78863-3003-1788633003012 BOTTLE, PLASTIC in 1 CARTON (78863-3003-1) / 5 mL in 1 BOTTLE, PLASTIC2024-04-01NoNoCurrent
78863-3003-2788633003023 BOTTLE, PLASTIC in 1 CARTON (78863-3003-2) / 5 mL in 1 BOTTLE, PLASTIC2024-04-01NoNoCurrent