Almay Healthy Biome Makeup

Manufacturer
Almay | Revlon, INC.
Effective date
2024-12-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:49:46

Label at a glance#

ProductAlmay Healthy Biome Makeup Tan
Active ingredientHOMOSALATE, OCTISALATE, ZINC OXIDE, OCTOCRYLENE, TITANIUM DIOXIDE
Label structure9 sections

Indications and uses

Helps prevent sunburn. if used as directed with other sun protection measures descreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Use water resistant sunscreen is swimming or sweating. Repply at least ever 2 hours. Children under 6 months; Ask a doctor.

Label contents#

Full prescribing information#

Active Ingredient Section

OTC - ACTIVE INGREDIENT SECTION

Homosalate 5.0%

Octisalate 5.0%

Octocrylene 5.0%

Titanium Dioxide 5.8%

Zinc Oxide 3.94%

Uses

OTC - PURPOSE SECTION

Helps prevent sunburn. if used as directed with other sun protection measures descreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only

Do not use on danaged skin or broken skin

Sun Protection Measures- Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am- 2pm. Wear long-sleeved shrirts, pants, hats and sunglasses.

When using this product

OTC - WHEN USING SECTION

Keep out of the eyes, Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swalled get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Use water resistant sunscreen is swimming or sweating. Repply at least ever 2 hours. Children under 6 months; Ask a doctor.

INACTIVE INGREDIENT SECTION

Other Ingredients: Aqua/Water/Eau, Cyclopentasiloxane, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Trimethylsiloxysilicate, Glycerin, Isododecane, Alumina, Magnesium Sulfate, Silica, Alpha-Glucan Oligosaccharide, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetyl Palmitate, Disteardimonium Hectorite, Hydrogen Dimethicone, Hydrogenated Lecithin, Lactobacillus, Maltodextrin, Ophiopogon Japonicus Root Extract, Palmitoyl Tetrapeptide-10, Polyglyceryl-3 Diisostearate, Polymnia Sonchifolia Root Juice, Polysorbate 80, Propylene Carbonate, Simethicone, Sorbitan Stearate, Tetrasodium EDTA, Tocopheryl Acetate, Triethoxycaprylylsilane, Phenoxyethanol.

MAY CONTAIN/PEUT CONTENIR/PUEDE CONTENER (+/-):
[Iron Oxides (CI 77491),Iron Oxides (CI 77492),Iron Oxides (CI 77499),Titanium Dioxide (CI 77891).]

INDICATIONS & USAGE SECTION

Helps prevent sunbunrs. If used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

back labelback labelfront labelfront label

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0311-07410311-0741-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Almay Healthy Biome Makeup TanHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEAlmay2a94a668-24cb-e0f2-e063-6294a90a79d32024-12-31WarningsExact identifier
ndc (package): 0311-0741-01
ndc (product): 0311-0741
ndc11 (package): 00311074101
spl id: 2a94bab8-28fd-edba-e063-6294a90a8e30
spl set id: 2a94a668-24cb-e0f2-e063-6294a90a79d3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.