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

Biore UV Aqua Rich by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 5%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

Use helps prevent sunburn

WARNINGS

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Cotrol Center right away.

DOSAGE & ADMINISTRATION

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: Ask 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, hats, and sunglasses

Other information

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

INACTIVE INGREDIENT

Inactive ingredients Water, Alcohol Denat., Lauryl Methacrylate/Sodium Methacxrylate Crosspolymer, Diethylhexyl 2,6-Naphthalate, Glyerin, Dextrin Palmitate, Niacinamide, Dicaprylyl Ether, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance, Mica, Glyceryl Behenate, Phyl Trimethicone, Cetyl Alcohol, Sorbitan Distearate, Sodium Hydroxide, Stearoyl Glutamic Acid, Arginine, Silica, Disodium EDTA, Sodium Hyaluronate, Phenoxyethanol, Citral, Geraniol, Limonene, Linalool, Iron Oxides

QUESTIONS

Questions or comments? 1-800-742-8798

SPL UNCLASSIFIED SECTION

Questions? 1-888-BIORE-11

biore.com

BIORE is a trademark of Kao Corp.

Distributed by Kao USA Inc.

Cincinnati, OH 45214 ©2024

Made in Canada

PRINCIPAL DISPLAY PANEL

Biore

US AQUA RICH

Glow Enhancing Moisturizer

+1% NIACINAMIDE

FOR EVEN SKIN TONE & A GLOWY FINISH

Biore UV

Aqua Rich

BROAD SPECTRUM

SPF 50

SUNSCREEN

PA++++

1.7 FL OZ (50 mL)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10596-198
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	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
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
LAURYL METHACRYLATE (UNII: B6L83074BZ)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
GLYCERIN (UNII: PDC6A3C0OX)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
ARGININE (UNII: 94ZLA3W45F)
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRAL (UNII: T7EU0O9VPP)
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GERANIOL (UNII: L837108USY)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
NIACINAMIDE (UNII: 25X51I8RD4)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL (UNII: D81QY6I88E)
MICA (UNII: V8A1AW0880)
SORBITAN DISTEARATE (UNII: CBG7F2IO1Y)
STEAROYL GLUTAMIC ACID (UNII: 4R4O71786G)
IRON OXIDES (UNII: 1K09F3G675)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10596-198-17	1 in 1 BOX	01/10/2025
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 Drug	M020	01/10/2025

Labeler - KAO USA (004251617)