FDA.reportPublic FDA data

Almay Healthy Biome Makeup

Product NDC
0311-0741
11-digit product format
003110741
Labeler code
0311
Product ID
0311-0741_2a94bab8-28fd-edba-e063-6294a90a8e30
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Octisalate, Octocrylene, Titanium Dioxide, Zinc Oxide
Dosage form
EMULSION
Route
TOPICAL
Labeler
Almay
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-07-01
Substance
HOMOSALATE; OCTISALATE; ZINC OXIDE; OCTOCRYLENE; TITANIUM DIOXIDE
Active strength
5; 5; 3.94; 5; 5.8 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
Almay Healthy Biome Makeup
Brand name suffix
Tan
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE5 mg/mL
OCTISALATE5 mg/mL
ZINC OXIDE3.94 mg/mL
OCTOCRYLENE5 mg/mL
TITANIUM DIOXIDE5.8 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
SOI2LOH54ZInternal UNII lookup
5A68WGF6WMInternal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2a94a668-24cb-e0f2-e063-6294a90a79d3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0311-0741-01Almay Healthy Biome MakeupTan1 mL in 1 TUBEEMULSION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0311-0741ALMAY HEALTHY BIOME MAKEUP TAN (HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE) EMULSION [ALMAY]1Current NDC, 1 package rows20250101_2a94a668-24cb-e0f2-e063-6294a90a79d3.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 59 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLC4ab66c16-5f4c-6987-e063-6294a90add862026-02-26Warnings, Adverse reactionsExact identifier
application number: M020
Seonglow Daily Moisturizing Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESeonGlow Inc.01f3479f-3a0d-420b-bbf8-62a0a225bc9b2026-02-26WarningsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLC4ab5d5ca-26bf-1c5f-e063-6394a90a00ca2026-02-26Warnings, Adverse reactionsExact identifier
application number: M020
SPF50 Moisturizer with Aloe, Green Tea and Shea ButterZINC OXIDEAudrey Morris Cosmetics International, LLC92960e14-9845-49aa-b3ce-c8023aa109b62026-02-26WarningsExact identifier
application number: M020
Naturalessa SPF50 MoisturizerZINC OXIDEAudrey Morris Cosmetics International, LLC816ddfa1-cb55-4591-a90b-71631cb176262026-02-26WarningsExact identifier
application number: M020
UV DEFENSE FACE MINERAL SPF 50ZINC OXIDEBETTER INVENTION LTD4b9a9efe-9aba-0ed0-e063-6394a90a2c6b2026-02-26WarningsExact identifier
application number: M020
MISTINE UV DEFENSE FACE SUNSCREEN SPF50AVOBENZONE, HOMOSOLATE, OCTISALATE, OCTOCRYLENEBETTER INVENTION LTD4b9a8f28-9043-8fb7-e063-6294a90a34d32026-02-26WarningsExact identifier
application number: M020
MISTINE UV INVISIBLE FACE SHEER SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBETTER INVENTION LTD4b9a8f28-9041-8fb7-e063-6294a90a34d32026-02-26WarningsExact identifier
application number: M020
Rationale The Discovery Travel KitZINC OXIDERATIONALE GROUP PTY LTD0c919aea-4bd4-427e-97e7-9c153b42f4912026-02-25WarningsExact identifier
application number: M020
Kiss My Face Purely Mineral Daily 50 Sunscreen SPF 50ZINC OXIDEWindmill Health Products, LLCebfb149c-0371-4492-b03a-5fdcb78217532026-02-25WarningsExact identifier
application number: M020
SHISEIDO UV PROTECTIVE COMPACT (REFILL) FAIR IVORYOCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONc05cef12-a6a7-4682-9357-6d77f4ca32672026-02-25WarningsExact identifier
application number: M020
cle de peau BEAUTE Protective DayAVOBENZONE, OCTINOXATE, OCTOCRYLENEShiseido Americas Corporationdea8e4c1-6a9c-44c6-abc8-6cdd50f35f492026-02-25WarningsExact identifier
application number: M020
Aura DefenseZINC OXIDEGrace and Glow MD LLC4ba75eff-74ef-278b-e063-6394a90a8ef02026-02-25WarningsExact identifier
application number: M020
AM Shield plusZINC OXIDEGrace and Glow MD LLC4ba7c282-c68e-8719-e063-6394a90a38142026-02-25WarningsExact identifier
application number: M020
cle de peau BEAUTE RADIANT FOUNDATION N M I10OCTINOXATE AND TITANIUM DIOXIDEShiseido Americas Corporation3be1fe06-bd3b-4078-bee9-d3caf8d068ff2026-02-25WarningsExact identifier
application number: M020
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4babe2ab-c5da-9a83-e063-6294a90aee4c2026-02-25WarningsExact identifier
application number: M020
Daily Facial Moisturizer SPF 25SUNSCREENPerson and Covey6b9258e4-c7c6-765e-e053-2991aa0a9f4e2026-02-25WarningsExact identifier
application number: M020
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4bac1c33-36fe-8d29-e063-6394a90a32a52026-02-25WarningsExact identifier
application number: M020
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4bac5550-c45f-a738-e063-6394a90ae5c82026-02-25WarningsExact identifier
application number: M020
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4baca374-7aaa-8d1d-e063-6394a90a5a552026-02-25WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0311-0741-01003110741011 mL in 1 TUBE (0311-0741-01) 1 ml2020-08-01NoNoCurrent