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 51 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mentholatum Natural Ice OriginalDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company29220eaa-87cb-4ebe-87db-d36288b3a9e42026-03-24WarningsExact identifier
application number: M020
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLCf54c617f-794e-413b-b898-4a06622b4bee2026-03-24Warnings, Adverse reactionsExact identifier
application number: M020
VITAL PERFECTION UPLIFTING AND FIRMING ADVANCED DAYAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENEShiseido Americas Corporation7b2d15c1-b9e1-4347-b138-9883f78822b32026-03-24WarningsExact identifier
application number: M020
Sunscreen SPF 50SUNSCREEN SPF 50Guangzhou Ariel Biotech Co., Ltd.4dd05620-30a3-9cea-e063-6294a90af18b2026-03-24WarningsExact identifier
application number: M020
Sunscreen SPF 50SUNSCREEN SPF 50Guangzhou Ariel Biotech Co., Ltd.4dd1b722-4448-9675-e063-6294a90a5f4f2026-03-24WarningsExact identifier
application number: M020
Sky and Sol Face and Body Sunscreen SPF30NON- NANO ZINC OXIDEDelta Ecommerce LLC2dda185c-6ff8-953d-e063-6394a90acc532026-03-24WarningsExact identifier
application number: M020
WHAMISA ORGANIC PEAR BLOSSOM SUNSCREENZINC OXIDEENS KOREA Co., Ltd.34f9688d-efa1-1d3f-e063-6294a90ab1272026-03-23WarningsExact identifier
application number: M020
HALORINNA SUN-SCREEN TRAVEL SPF50SUN SCREENGuangdong Bisutang Biotechnology Co., LTD4dade579-ce77-eea5-e063-6394a90ad46a2026-03-23WarningsExact identifier
application number: M020
TIRTIR SUN BOUNCY GLOW LIP BALM SPF30 - 01 HAZY MAUVEZINC OXIDETIRTIR USA Inc.4c92db00-59f1-ac02-e063-6394a90a7cf12026-03-23WarningsExact identifier
application number: M020
Zinc Oxide 20%SUNSCREEN SPF 50The Soleil Group, LLC27d20573-0b6b-4d4b-94ca-69b476a883a72026-03-23WarningsExact identifier
application number: M020
Babo Botanicals Hydrating Milk Mineral Sunscreen SPF 30ZINC OXIDEBabo Botanicals, Inc.4db37efb-2d37-7428-e063-6394a90a10e42026-03-23WarningsExact identifier
application number: M020
All Good Mineral Sport Sunscreen ButterZINC OXIDEElemental Herbs, Inc.ff334e9c-dd12-92bc-e053-6394a90aa24b2026-03-23WarningsExact identifier
application number: M020
All Good Tinted Mineral Sunscreen Butter SPF 50ZINC OXIDEElemental Herbs, Inc.fe2bf779-e8b3-933f-e053-6394a90a369f2026-03-23WarningsExact identifier
application number: M020
ULTRA SOOTHER DRY-TOUCH SUNSCREENHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEskinnplus4dbc1035-c41c-308c-e063-6394a90a36c42026-03-23WarningsExact identifier
application number: M020
Daily Defense Mineral Sunscreen Serum Broad Spectrum SPF 33ZINC OXIDEEva's Esthetics0dd7cba3-bc74-4ec1-bd4a-a2f3ed533fc72026-03-23WarningsExact identifier
application number: M020
MELAO Rice Probiotics SunscreenZINC OXIDE,ETHYLHEXYL SALICYLATE,ETHYLHEXYL METHOXYCINNAMATEGuangdong Aimu Biological Technology Co., Ltd4ccaa734-83c1-611b-e063-6294a90ab3bf2026-03-21WarningsExact identifier
application number: M020
Vacation Lip Trips Desserts Pineapple Upside Down CakeAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation Inc.69022828-8226-4977-a2ca-ad8e16793a592026-03-20WarningsExact identifier
application number: M020
VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation Inc.c7794831-52d1-4d80-936d-44af18ae04722026-03-20WarningsExact identifier
application number: M020
YOUARE SUNSHINE Broad Spectrum SPF 50 Mineral SunscreenZINC OXIDECA-Botana International4d74a36c-ff68-afd9-e063-6394a90a08f82026-03-20WarningsExact identifier
application number: M020
Lancome Paris UV Expert Aquagel Defense 50 Plus SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENESICOS ET CIE468d4ed2-e616-aaaf-e063-6294a90af37a2026-03-20WarningsExact 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