FEVANZON Isolation Sunscreen

FEVANZON Isolation Sunscreen by

Drug Labeling and Warnings

FEVANZON Isolation Sunscreen by is a Otc medication manufactured, distributed, or labeled by HBB INTERNATIONAL INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FEVANZON ISOLATION SUNSCREEN- avobenzone,homosalate,octisalate,oxybenzone liquid 
HBB INTERNATIONAL INC

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.

----------

FEVANZON Isolation Sunscreen

Active Ingredients

Avobenzone,homosalate,Octisalate,Oxybenzone,Octocrylene.

Purpose

sunscreen

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.
• Due to the difference of our skin, this may not be for everyone, try it first on your sensitive part of skin, if any discomfort occurs, stop use right away.

Keep out of reach of children.

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

Directions :

• After cleansing the skin and done other skin care measures, take proper amount of the product and spread evenly on the face, if exposed to direct sunshine, reapply every 30-60 minutes

Uses

Brightening sunscreen

Inactive Ingredient

Water, butylene glycol, dicaprylyl carbonate, ethylhexyl salicylate, glycerin, PEG/PPG-17/6 copolymer, isononyl isononanoate, silica, tetrapeptide-2, nonapeptide-1, palmitoyl oligopeptide, polyvinyl alcohol, glyceryl caprylate, nicotinamide adenine dinucleotide, glyceryl stearate citrate, potassium cetyl phosphate, acrylates/C10-30 alkyl acrylate crosspolymer, arginine, xanthan gum, disodium EDTA, phenoxyethanol, methylparaben, fragrance.

Package

FEVANZON ISOLATION SUNSCREEN 
avobenzone,homosalate,octisalate,oxybenzone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80815-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	6 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
GLYCERIN (UNII: PDC6A3C0OX)
PEG/PPG-17/6 COPOLYMER (UNII: P5QZM4T259)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TETRAPEPTIDE-2 (UNII: 7BQ5P2574K)
NONAPEPTIDE-1 (UNII: 64W45420K5)
MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
POLYVINYL ALCOHOL (100000 MW) (UNII: 949E52Z6MY)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
DISODIUM NICOTINAMIDE ADENINE DINUCLEOTIDE (UNII: 8295030YNC)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ARGININE (UNII: 94ZLA3W45F)
XANTHAN GUM (UNII: TTV12P4NEE)
DISODIUM EDTA-COPPER CU-64 (UNII: 4J875U5U11)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80815-003-01	50 in 1 CARTON	08/22/2020	08/22/2020
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/22/2020	08/22/2020

Labeler - HBB INTERNATIONAL INC (117557618)

Revised: 12/2021

Document Id: d2809b4b-9944-3b8d-e053-2995a90ab332

34390-5

Set id: cfc73e42-bee0-43cb-9561-c94b3d065592

Version: 3

Effective Time: 20211206