Drug Facts

Active Ingredients	Purpose
Homosalate 14.5%	sunscreen
Ethylhexyl Salicylate 5%	sunscreen
Avobenzone 3%	sunscreen

Uses

Helps prevent sunburn.
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.

Warnings

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure.
Reapply at least every 2 hours.
Use a water resistant sunscreen if swimming or sweating.
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 of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10am-2pm.
- Wear long-sleeve shirts, pants, hats & sunglasses.
Children under 6 months of age: Ask a doctor.

Inactive Ingredients

Water, Octyldodecyl Neopentanoate, Glycerin, HDI/PPG/Polycaprolactone Crosspolymer, Butyloctyl Salicylate, Propanediol, Sorbeth-30 Tetraisostearate, Isododecane, VP/Eicosene Copolymer, VP/Acrylates/Lauryl Methacrylate Copolymer, Triacontanyl PVP, VP/Hexadecene Copolymer, Alcohol, Acetyl Hexapeptide-8, Panthenol, Sodium Hyaluronate, Aloe Barbadensis Leaf Extract, Tamarindus Indica Fruit Extract, Centella Asiatica Extract, Potassium Sorbate, Potassium Hydroxide, Phenoxyethanol, Sorbitan Sesquiisostearate, PPG-8 Ceteth-20, Acrylates/Beheneth-25 Methacrylate Copolymer, Dipropylene Glycol, Disodium EDTA, Hydroxyethylcellulose

Other Information

Protect the product in this container from excessive heat and direct sun.

Questions?

800-294-7700 9-5pm EST, Monday-Friday

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

m-61®
powerful skincare

Hydraboost
Oil-Free
Sunscreen
SPF 40

BROAD SPECTRUM SPF 40
HYDRATING PEPTIDE AND
VITAMIN B5 REEF SAFE
SUNSCREEN

Lightweight SPF 40 with
a power-packed peptide,
vitamin B5 & tamarind

all skin types

100% paraben-free
100% synthetic fragrance-free
dermatologist tested
allergy tested

50 mL ℮ 1.7 FL. OZ.

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

HYDRABOOST OIL-FREE SUNSCREEN SPF 40
homosalate, octisalate, and avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72203-015
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	145 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Octyldodecyl Neopentanoate (UNII: X8725R883T)
Glycerin (UNII: PDC6A3C0OX)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Propanediol (UNII: 5965N8W85T)
Isododecane (UNII: A8289P68Y2)
Vinylpyrrolidone/Eicosene Copolymer (UNII: 035MV9S1C3)
Tricontanyl Povidone (UNII: N0SS3Q238D)
Vinylpyrrolidone/Hexadecene Copolymer (UNII: KFR5QEN0N9)
Alcohol (UNII: 3K9958V90M)
Acetyl Hexapeptide-8 (UNII: L4EL31FWIL)
Panthenol (UNII: WV9CM0O67Z)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Tamarind Juice (UNII: 5P6V8403U4)
Centella Asiatica Whole (UNII: 7M867G6T1U)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Potassium Hydroxide (UNII: WZH3C48M4T)
Phenoxyethanol (UNII: HIE492ZZ3T)
Sorbitan Sesquiisostearate (UNII: VU97D01BF9)
Ppg-8-Ceteth-20 (UNII: MAL0SND89Q)
Dipropylene Glycol (UNII: E107L85C40)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
Hydroxyethyl Cellulose, Unspecified (UNII: T4V6TWG28D)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72203-015-01	1 in 1 CARTON	04/01/2021
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	04/01/2021

Labeler - Bluemercury (097435361)

Name	Address	ID/FEI	Business Operations
Establishment
Biogenesis, Inc.		069117328	MANUFACTURE(72203-015)