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 302 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SOLVADERM Dermaxsol Dermal Defense Moisturizer SPF-30OCTOCRYLENE, ZINC OXIDESOLVADERM LLC0f9a507a-1b72-45f8-a8a8-b7a92a85607f2024-03-21WarningsExact identifier
application number: M020
Daily Prevention Protect and Refresh Mist SPF 40AVOBENZONE, OCTISALATE AND OCTOCRYLENEAllure Labs142f99de-176e-ad11-e063-6394a90a935b2024-03-21WarningsExact identifier
application number: M020
PHYSIOGEL Daily Moisture Therapy Barrier Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDEfmg Co.Ltd1410c6d9-eff0-f90b-e063-6394a90a94032024-03-20WarningsExact identifier
application number: M020
ETADERM Tattoo Sunscreen Broad Spectrum SPF-30ZINC OXIDENUEPHASE LLCcc1e3485-57e6-4ac9-96b3-2d683beb5b532024-03-20WarningsExact identifier
application number: M020
Daily Prevention Advanced Smartblend Mineral Moisturizer SPF 75TITANIUM DIOXIDE AND ZINC OXIDEAllure Labs141bb721-cd1c-5bba-e063-6394a90ab8fa2024-03-20WarningsExact identifier
application number: M020
Sunscreen-LotionZINC OXIDE, TITANIUM DIOXIDEShanghai Chuangshi Medical Technology (Group) Co., Ltd.0511ff57-b7bd-4708-e063-6294a90a58a82024-03-20WarningsExact identifier
application number: M020
Daily Prevention Ultra Defense Moisturizer SPF 50HOMOSALATE, OCTISALATE,OCTOCRYLENE AND ZINC OXIDEAllure Labs14070076-8c57-e2f1-e063-6394a90a0dfc2024-03-19WarningsExact identifier
application number: M020
PHYSIOGEL Daily Moisture Therapy Barrier Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDELG H&H Co., Ltd.140feb1e-a72f-ade4-e063-6394a90a11fb2024-03-19WarningsExact identifier
application number: M020
Daily Prevention Sheer Matte Moisturizer SPF30HOMOSALATE AND OCTISALATE AND ZINC OXIDEAllure Labs13b5c78c-f950-699b-e063-6294a90a98982024-03-15WarningsExact identifier
application number: M020
Daily Prevention Pure Mineral Tinted Moisturizer SPF 30TITANIUM DIOXIDE AND ZINC OXIDEAllure Labs13bc141b-a30f-2661-e063-6294a90aca2b2024-03-15WarningsExact identifier
application number: M020
BB Ambre 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs13a3ec97-0d0a-d639-e063-6294a90a0bf82024-03-14WarningsExact identifier
application number: M020
Mineral ShakeZINC OXIDEVacation Inc.131b7e65-7155-f925-e063-6394a90a1d7a2024-03-13WarningsExact identifier
application number: M020
BB Blanc 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs137a1528-c487-8bf3-e063-6294a90ade842024-03-12WarningsExact identifier
application number: M020
BB Sienna 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs137bff4a-5156-b12c-e063-6394a90abe632024-03-12WarningsExact identifier
application number: M020
Vacation SuperAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEVacation Inc.137c350b-dca1-47f7-e063-6294a90a531e2024-03-12WarningsExact identifier
application number: M020
Avene Hydrance Moisturizing SPF 30ZINC OXIDEPierre Fabre USA Inc.1361ebe5-2659-d88f-e063-6294a90a71bb2024-03-11WarningsExact identifier
application number: M020
BB Brite 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs13660aee-3b28-7e3e-e063-6294a90a82cc2024-03-11WarningsExact identifier
application number: M020
BB Bronze 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs13679e50-01ef-9a8f-e063-6294a90ac5772024-03-11WarningsExact identifier
application number: M020
Advanced Firming And Anti-Wrinkle Day SPF 18 EQBAVOBENZONE 2% OCTISALATE 5% OCTOCRYLENE 5%Walmart358dfed4-1c6d-400e-8e6f-331fbc76a8342024-03-11WarningsExact identifier
application number: M020
Avene Mineral Sunscreen Stick SPF 50ZINC OXIDEPierre Fabre USA Inc.1368482f-3a72-ffa9-e063-6394a90a603e2024-03-11WarningsExact 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