FDA.reportPublic FDA data

5299 SUNSCREEN

Product NDC
76138-221
11-digit product format
761380221
Labeler code
76138
Product ID
76138-221_5f020bbb-634a-560e-e063-6394a90aed9b
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octocrylene, Octisalate
Dosage form
LOTION
Route
TOPICAL
Labeler
Innovation Specialties
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-05-10
Substance
AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE
Active strength
30; 100; 100; 50 mg/mL; mg/mL; mg/mL; mg/mL
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
5299 SUNSCREEN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE100 mg/mL
OCTOCRYLENE100 mg/mL
OCTISALATE50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
5A68WGF6WMInternal 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
f3db6bd8-cc6f-4af5-809d-95fb05f6732fAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76138-221-062024-01-30C16284748780-11030e364-ff02-111a-e063-dadaa90a10e25299 SUNSCREEN
76138-221-062024-01-30C16284748780-11030e364-ff02-111a-e063-dadaa90a10e25299 SUNSCREEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76138-221-065299 SUNSCREEN20 mL in 1 BOTTLELOTION203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76138-2215299 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) LOTION [INNOVATION SPECIALTIES]3Current NDC, Legacy NDC, 1 package rows20240712_f3db6bd8-cc6f-4af5-809d-95fb05f6732f.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 245 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c62206-d83b-8d9a-e063-6394a90a4c692024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c618ae-3d24-8c87-e063-6394a90a53962024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c62206-d830-8d9a-e063-6394a90a4c692024-12-26WarningsExact identifier
application number: M020
Bubble Solar Mate Daily Mineral Sunscreen SPF 40ZINC OXIDECOSMAX USA, CORPORATION0d35fa3c-e6eb-d9ff-e063-6394a90a5a6e2024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c6035e-c178-b3e6-e063-6394a90a86cd2024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c62206-d838-8d9a-e063-6394a90a4c692024-12-26WarningsExact identifier
application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 LightAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporationfbbff4eb-a63e-b083-e053-6294a90a404a2024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c6035e-c179-b3e6-e063-6394a90a86cd2024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c618ae-3d4d-8c87-e063-6394a90a53962024-12-26WarningsExact identifier
application number: M020
KOPARI Sun Shield Soft Glow Daily Face SPF30OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATECOSMAX USA, CORPORATION0d436d06-3f81-b4a6-e063-6294a90aa6352024-12-26WarningsExact identifier
application number: M020
NEORA Invisibloc Sunscreen Gel Broad Spectrum SPF40AVOBENZONE, HOMOSALATE, OCTISALATECOSMAX USA, CORPORATION0d584736-3f55-2542-e063-6294a90af3cf2024-12-26WarningsExact identifier
application number: M020
NARS Radiance Primer Broad Spectrum SPF 35 SunscreenOCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATECOSMAX USA, CORPORATION0d59d9cb-c891-1097-e063-6394a90a806e2024-12-26WarningsExact identifier
application number: M020
KOPARI Sun Shield Soft Glow Daily Face SPF30OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATECOSMAX USA, CORPORATION0d3673da-822b-09e2-e063-6394a90a348e2024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c61c42-eddb-1ebd-e063-6294a90aee132024-12-26WarningsExact identifier
application number: M020
GLOSSIER INVISIBLE SHIELD DAILY SUNSCREEN BROAD SPECTRUM SPF 35AVOBENZONE, HOMOSALATE, OCTISALATECOSMAX USA, CORPORATION0d438692-cd83-ea42-e063-6394a90a862d2024-12-26WarningsExact identifier
application number: M020
KOPARI Antioxidant Face Shield Mineral SPF 30ZINC OXIDECOSMAX USA, CORPORATION0d43e22c-5e3d-df90-e063-6294a90aac2b2024-12-26WarningsExact identifier
application number: M020
NORWEX Protect Prevent Mineral Facial Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, CORPORATION0d489154-6168-977e-e063-6394a90aa6092024-12-26WarningsExact identifier
application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 FairAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporationfbbfa61a-cbb4-3104-e053-6394a90a832f2024-12-26WarningsExact identifier
application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 Tan to darkAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporatione6c4b8eb-5aa3-49c2-af9e-eaf5fafb029c2024-12-26WarningsExact identifier
application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 Light to MediumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporationfbc05ceb-2e6b-3c37-e053-6394a90ac4f42024-12-26WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76138-221-067613802210620 mL in 1 BOTTLE (76138-221-06) 20 ml2022-05-100000-00-00NoNoCurrent