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 3 of 361 · 7,213 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Wave Anti Aging Insta Dry SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC7e48a3d2-e453-4733-b42b-8bea804cda592026-09-01WarningsExact identifier
application number: M020
Sun Wave Anti Aging Lite SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC7204c24f-aab6-45eb-9bd4-879f715ba0752026-09-01WarningsExact identifier
application number: M020
Sun Wave Anti Aging Lite SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC7c1e780a-1831-4f49-a92e-e36017d241a22026-09-01WarningsExact identifier
application number: M020
Sun Wave Cross Sport Insta Dry SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLCd45614c8-b09c-417b-b691-082ea21498802026-09-01WarningsExact identifier
application number: M020
Sun Wave Cross Sport Insta Dry SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC999b0b17-be73-4d42-b182-ce038f4933012026-09-01WarningsExact identifier
application number: M020
Sun Wave Cross Sport Insta Dry SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLCadffff46-4cfb-4c0a-b1a6-75220ee193a52026-09-01WarningsExact identifier
application number: M020
Sun Wave Cross Sport Insta Dry SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC13b2b45b-70e1-46ff-8555-48e1fe98c6512026-09-01WarningsExact identifier
application number: M020
Sun Wave Kids Insta Dry SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC5c2a5ca3-e9eb-48ba-8698-592d2c7aa2412026-09-01WarningsExact identifier
application number: M020
Sunceutical SPF 50 Mineral Face CreamZINC OXIDEBaxter Laboratories Pty. Ltd.2c408728-a1de-d51e-e063-6294a90ade0b2026-08-31WarningsExact identifier
application number: M020
SKIN1004 MADAGASCAR CENTELLA HYALU-CICA WATER-FIT SUN SERUM UVBUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENECraver Corporation38d8c1c9-86b5-1edd-e063-6394a90aeb472026-08-30WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID DAILY SUNGELAVOBENZONE, HOMOSALATE, OCTISALATEISNTREE Inc.5a3a17ff-a7fd-f707-e063-6394a90a31822026-08-29WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID NATURAL SUNCREAMZINC OXIDEISNTREE Inc.5a3a59b2-18b6-521b-e063-6294a90a29582026-08-29WarningsExact identifier
application number: M020
Cetaphil Daily Facial Moisturizer with suncreen SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGalderma Laboratories, L.P.f5eb347f-0d46-4de6-8f3f-9010327678ed2026-08-28WarningsExact identifier
application number: M020
Utu Broad Spectrum SPF 30 Moisturizing Body SunscreenZINC OXIDEUtu Co59938ace-c97c-d758-e063-6394a90a77e42026-08-28WarningsExact identifier
application number: M020
Utu Broad Spectrum SPF 30 Moisturizing Face Mineral Zinc Oxide Sunscreen UnscentedZINC OXIDEUtu Co5982e790-7cdb-c96c-e063-6394a90a02d42026-08-28WarningsExact identifier
application number: M020
Utu Hydrating Sun Balm Broad Spectrum SPF 50ZINC OXIDEUtu Co59d1d0ac-2444-d6f9-e063-6294a90ae80c2026-08-28WarningsExact identifier
application number: M020
Hello Bello Mineral Sunscreen SPF 50ZINC OXIDETopiderm, Inc.54f12764-5c37-4a05-bf96-209fedb93fd12026-08-28WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID DAILY SUNGELAVOBENZONE, HOMOSALATE, OCTISALATEISNTREE Inc.5a02c540-5b3b-9379-e063-6294a90a00f62026-08-27WarningsExact identifier
application number: M020
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
application number: M020
Round Lab Holiday Heroes Gift SetAVOBENZONE, HOMOSALATE, OCTISALATESEORIN COMPANY Co., Ltd.5a0d3a85-caff-a90d-e063-6394a90ad0452026-08-27WarningsExact 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