Label: BIORE AQUA RICH UV- octocrylene, octisalate, avobenzene, homosalate liquid
- NDC Code(s): 10596-197-17
- Packager: KAO USA
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 10, 2023
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- Drug facts
- Active ingredients
- Purpose
- Use
- Warnings
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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
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Inactive ingredients
Water, alcohol denat., lauryl methacrylate/sodium methacrylate crosspolymer, dextrin palmitate, glycerin, phenyl trimethicone, dimethicone, dipropylene glycol, acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, glyceryl behenate, cetyl alcohol, sorbitan distearate, isoceteth-20, sodium hydroxide, stearoyl glutamic acid, arginine, disodium EDTA, sodium hyaluronate, phenoxyethanol, citral, geraniol, limonene, linalool.
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INGREDIENTS AND APPEARANCE
BIORE AQUA RICH UV
octocrylene, octisalate, avobenzene, homosalate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10596-197 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) GLYCERYL MONOBEHENATE (UNII: A626UU0W2A) LAURYL METHACRYLATE (UNII: B6L83074BZ) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PHENOXYETHANOL (UNII: HIE492ZZ3T) GERANIOL (UNII: L837108USY) LINALOOL, (+/-)- (UNII: D81QY6I88E) CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L) WATER (UNII: 059QF0KO0R) LIMONENE, (+)- (UNII: GFD7C86Q1W) CETYL ALCOHOL (UNII: 936JST6JCN) SORBITAN DISTEARATE (UNII: CBG7F2IO1Y) ISOCETETH-20 (UNII: O020065R7Z) SODIUM HYDROXIDE (UNII: 55X04QC32I) ARGININE (UNII: 94ZLA3W45F) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) CITRAL (UNII: T7EU0O9VPP) DIMETHICONE (UNII: 92RU3N3Y1O) DIPROPYLENE GLYCOL (UNII: E107L85C40) STEAROYL GLUTAMIC ACID (UNII: 4R4O71786G) ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10596-197-17 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)
