ALMAY HEALTHY BIOME MAKEUP MEDIUM- homosalate, octisalate, octocrylene, titanium dioxide, zinc oxide emulsion

Almay Healthy Biome Makeup by

Drug Labeling and Warnings

Almay Healthy Biome Makeup by is a Otc medication manufactured, distributed, or labeled by Almay, Revlon, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient Section

Homosalate 5.0%

Octisalate 5.0%

Octocrylene 5.0%

Titanium Dioxide 5.8%

Zinc Oxide 3.94%

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.

Warnings

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

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

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

Directions

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

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

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALMAY HEALTHY BIOME MAKEUP  MEDIUM
homosalate, octisalate, octocrylene, titanium dioxide, zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0311-0739
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3.94 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5.8 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN)
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PALMITOYL TETRAPEPTIDE-10 (UNII: 6Q6H1PKC05)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE SODIUM (UNII: MP1J8420LU)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
OPHIOPOGON JAPONICUS ROOT (UNII: 90PS6JV9GZ)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ISODODECANE (UNII: A8289P68Y2)
ALUMINUM OXIDE (UNII: LMI26O6933)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PEG-20 SORBITAN STEARATE (UNII: HD40WR33LC)
SMALLANTHUS SONCHIFOLIUS WHOLE (UNII: 4P5T8DTR73)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0311-0739-01	1 mL in 1 TUBE; Type 0: Not a Combination Product	08/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/01/2020

Labeler - Almay (064988652)

Establishment
Name	Address	ID/FEI	Business Operations
Revlon, INC.		809725570	manufacture(0311-0739)