BIORE AQUA RICH UV- octocrylene, octisalate, avobenzene, homosalate liquid

Biore Aqua Rich UV by

Drug Labeling and Warnings

Biore Aqua Rich UV by is a Otc medication manufactured, distributed, or labeled by KAO USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 5%

Purpose

Sunscreen

Use

helps prevent sunburn

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

For sunscreen use:

• apply generously and evenly 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• children under 6 months of age: Ak a doctor
• 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 10 a.m. - 2 p.m.

wear long-sleeved shirts, pants, hat, and sunglasses

Other information

protect the product in this container from excessive heat and direct sun

Inactive ingredients

Water, alcohol denat., lauryl methacrylate/sodium methacrylate crosspolymer, diethylhexyl 2,6-naphthalate, glycerin, dextrin palmitate, dicaprylyl ether, acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, glyceryl behenate, phenyl trimethicone, cetyl alcohol, sorbitan distearate, sodium hydroxide, stearoyl glutamic acid, arginine, disodium EDTA, sodium haluronate, phenoxyethanol, citral, geraniol, limonene, linalool.

Questions

or comments? 1-800-BIORE-11

SPL UNCLASSIFIED SECTION

Questions? 1-888-BIORE-11

biore.com

BIORE is a trademark of Kao Corp.

Distributed by Kao USA Inc.,

Cincinnatti, OH 45214 ©2022

Made in Canada

PRINCIPAL DISPLAY PANEL

Biore

UV Aqua Rich

Weightless Moisturizer

BROAD SPECTRUM SPF 50 SUNSCREEN

1.7 FL OZ (50 mL)

INGREDIENTS AND APPEARANCE

BIORE AQUA RICH UV 
octocrylene, octisalate, avobenzene, homosalate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10596-195
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)
LAURYL METHACRYLATE (UNII: B6L83074BZ)
ARGININE (UNII: 94ZLA3W45F)
SORBITAN DISTEARATE (UNII: CBG7F2IO1Y)
CITRAL (UNII: T7EU0O9VPP)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
GLYCERIN (UNII: PDC6A3C0OX)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
CETYL ALCOHOL (UNII: 936JST6JCN)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
STEAROYL GLUTAMIC ACID (UNII: 4R4O71786G)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10596-195-17	1 in 1 BOX	04/10/2023
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	04/10/2023

Labeler - KAO USA (004251617)