Avobenzone, Homosalate, Octisalate

Product NDC
55910-442
11-digit product format
559100442
Labeler code
55910
Product ID
55910-442_4c110e1b-5525-3dea-e063-6294a90a97f6
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
2023-07-25
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
b3d2da09-d9c9-4c27-82fe-a434ece2f099Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-442-14Avobenzone, Homosalate, Octisalate156 g in 1 BOTTLE, SPRAYSPRAY1565
55910-442-39Avobenzone, Homosalate, Octisalate312 g in 1 BOTTLE, SPRAYSPRAY3125

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-442AVOBENZONE, HOMOSALATE, OCTISALATE SPRAY [OLD EAST MAIN CO.]3Current NDC, 2 package rows20240727_b3d2da09-d9c9-4c27-82fe-a434ece2f099.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 85 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daily Dose Bioretinol Mineral SPF 40ZINC OXIDESupergoop, LLCeb5bbc70-dbdf-06a8-e053-2995a90a66c12026-01-09WarningsExact identifier
application number: M020
Unseen Sunscreen Body SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCec1c30bd-76e1-9d00-e053-2a95a90a17592026-01-09WarningsExact identifier
application number: M020
Glow Screen SPF 40AVOBENZONE, OCTISALATE, OCTOCYLENESupergoop, LLC21569637-332a-461b-bf6c-33af6a83a1552026-01-09WarningsExact identifier
application number: M020
Glowscreen SPF 40 - DawnAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCf07145d5-b74d-7757-e053-2a95a90ac4c02026-01-09WarningsExact identifier
application number: M020
Glowscreen SPF 40 -SunsetAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCf7e493da-8fc6-191d-e053-6294a90aa4832026-01-09WarningsExact identifier
application number: M020
Supergoop Glow Screen SPF 40 Shade 2 Golden HourBROAD SPECTRUM SUNSCREENSupergoop LLCd2928dd7-a813-4929-e053-2a95a90aaeb42026-01-09WarningsExact identifier
application number: M020
Superscreen Hydrating Daily Cream SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCff0e4e97-8f01-bd36-e053-6394a90a47ae2026-01-09WarningsExact identifier
application number: M020
Lipshade SPF 30 Hey YallZINC OXIDESupergoop, LLCf93dfa13-ff18-ee38-e053-6394a90aea462026-01-09WarningsExact identifier
application number: M020
Triple Prep SPF 40AVOBENZONE, OCTISALATE, OCTOCRYLENE, HOMOSALATESupergoop, LLC004df4e5-dba9-6030-e063-6394a90a76d32026-01-09WarningsExact identifier
application number: M020
Unseen Sunscreen Lip Protector SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC12605fb4-0de6-94f3-e063-6294a90a3a6f2026-01-09WarningsExact identifier
application number: M020
Unseen Sunscreen Stick SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC2735c5c7-a4ef-33c3-e063-6294a90abf972026-01-09WarningsExact identifier
application number: M020
PLAY Sunscreen SPF 50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONESupergoop LLC2860d42c-d644-8b5a-e063-6394a90aec102026-01-09WarningsExact identifier
application number: M020
PLAY Mineral SPF 30 with Green AlgaeZINC OXIDESupergoop LLC29a1ff4b-3875-5275-e063-6394a90a53fd2026-01-09WarningsExact identifier
application number: M020
Every. Single. Face. Watery SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCd086a9b8-19e5-f713-e053-2995a90aa9762026-01-09WarningsExact identifier
application number: M020
3D Tinted Moisturizing BS SPF 30ZINC OXIDEAllure Labs47fd415f-819e-bbb8-e063-6394a90a2c6a2026-01-09WarningsExact identifier
application number: M020
ST MORIZ SUNCARE BODY SUNSCREEN SPF50SUNCARE BODY SUNSCREEN SPF50Aopline Biotechnology (Guangzhou) Co., Ltd.4801cfd2-1fe2-d118-e063-6294a90a6c8b2026-01-09WarningsExact identifier
application number: M020
ST MORIZ SUNCARE BODY SUNSCREEN SPF30SUNCARE BODY SUNSCREEN SPF30Aopline Biotechnology (Guangzhou) Co., Ltd.48026f09-6d15-8fa6-e063-6294a90a17cb2026-01-09WarningsExact identifier
application number: M020
RODAN and FIELDS ENHANCEMENTS MEDIUMTITANIUM DIOXIDE, ZINC OXIDEBentley Laboratories, LLC6aa6ad3f-2c52-4031-9e6c-7526c42de71d2026-01-09WarningsExact identifier
application number: M020
FACE SPF 47 SETTINGFACE SPF 47 SETTING SPRAYAopline Biotechnology (Guangzhou) Co., Ltd.47db9a54-c02f-d2ea-e063-6394a90ab9732026-01-08WarningsExact identifier
application number: M020
BADABOOM SUNSCREENSUNSCREENAopline Biotechnology (Guangzhou) Co., Ltd.47dbf363-2892-4530-e063-6294a90abe1f2026-01-08WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55910-442-1455910044214156 g in 1 BOTTLE, SPRAY (55910-442-14) 156 g2023-08-11NoNoCurrent
55910-442-3955910044239312 g in 1 BOTTLE, SPRAY (55910-442-39) 312 g2023-08-11NoNoCurrent