Avobenzone, Homosalate, Octisalate

Product NDC
75712-944
11-digit product format
757120944
Labeler code
75712
Product ID
75712-944_4c1123ce-dc29-c01e-e063-6394a90ab5d8
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate
Dosage form
SPRAY
Route
TOPICAL
Labeler
Old East Main Co.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-08
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength
30; 120; 50 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
Avobenzone, Homosalate, Octisalate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/g
HOMOSALATE120 mg/g
OCTISALATE50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1a53d8d5-e650-4825-8a3b-7cf42c36e3e5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75712-944-39Avobenzone, Homosalate, Octisalate312 g in 1 CANSPRAY3125

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75712-944AVOBENZONE, HOMOSALATE, OCTISALATE SPRAY [OLD EAST MAIN CO.]3Current NDC, 1 package rows20241013_1a53d8d5-e650-4825-8a3b-7cf42c36e3e5.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 238 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sheglam Dew and Done Skin Tint with SPF 20 AlmondZINC OXIDEEVER FAME PTE. LTD.2abbd076-825d-df76-e063-6294a90a22fc2025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 ButterZINC OXIDEEVER FAME PTE. LTD.2abbf4a1-a404-b36c-e063-6394a90a41a82025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 ButterscotchZINC OXIDEEVER FAME PTE. LTD.2abc0d57-cf8b-2508-e063-6294a90a8ee02025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 CappuchinoZINC OXIDEEVER FAME PTE. LTD.2abc72f5-d1fd-c4f4-e063-6394a90aab9a2025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 CamelZINC OXIDEEVER FAME PTE. LTD.2abc3ffb-ce18-6a64-e063-6294a90a8ab12025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 CaramelZINC OXIDEEVER FAME PTE. LTD.2abc2ce2-bf4d-4efd-e063-6294a90ae9882025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 CashewZINC OXIDEEVER FAME PTE. LTD.2abc9c3c-2a0f-6838-e063-6394a90ac4f22025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 ChantillyZINC OXIDEEVER FAME PTE. LTD.2abcaa9e-2f93-44a8-e063-6394a90a76442025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 EarthZINC OXIDEEVER FAME PTE. LTD.6d801c70-2954-408a-a023-bf9ed7b3aaa82025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 ChesnutZINC OXIDEEVER FAME PTE. LTD.2abc95a2-0f4a-8d52-e063-6294a90a102c2025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 Dark CloveZINC OXIDEEVER FAME PTE. LTD.2abcddde-f160-f7df-e063-6294a90a0f982025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 CocoaZINC OXIDEEVER FAME PTE. LTD.2abc98e3-079e-5797-e063-6394a90aff602025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 Deep CoffeeZINC OXIDEEVER FAME PTE. LTD.2abcf16f-52d6-3f91-e063-6294a90a84ef2025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 FairZINC OXIDEEVER FAME PTE. LTD.2abcfc81-c860-0e8d-e063-6294a90a0f422025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 HoneyZINC OXIDEEVER FAME PTE. LTD.2abd4192-fee2-ca74-e063-6294a90a1e1d2025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 GoldenZINC OXIDEEVER FAME PTE. LTD.2abcf16f-5320-3f91-e063-6294a90a84ef2025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 HazelnutZINC OXIDEEVER FAME PTE. LTD.2abd4192-fee0-ca74-e063-6294a90a1e1d2025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 LinenZINC OXIDEEVER FAME PTE. LTD.2abd4227-4fcf-266c-e063-6394a90a293b2025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 MahoganyZINC OXIDEEVER FAME PTE. LTD.2abd75c3-554a-d428-e063-6294a90ae77d2025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 MochaZINC OXIDEEVER FAME PTE. LTD.2abd75c3-554f-d428-e063-6294a90ae77d2025-01-02WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75712-944-3975712094439312 g in 1 CAN (75712-944-39) 312 g2023-08-08NoNoCurrent