PAPA RECIPE HONEY MOIST SUN ESSENCE- octinoxate, homosalate, octisalate, titanium dioxide cream 
Costory Co., Ltd

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.

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ACTIVE INGREDIENT

Active ingredients:

Ethylhexyl Methoxycinnamate 7.0%, Homosalate 3.0%, Ethylhexyl Salicylate 3.0%, Titanium Dioxide 1.49%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Alcohol, Pentylene Glycol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Caprylyl Methicone, Isononyl Isononanoate, Ethylhexyl Triazone, Glycerin, 1,2-Hexanediol, Polyglyceryl-3 Methylglucose Distearate, Sodium Hyaluronate, Biosaccharide Gum-4, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, Cyclopentasiloxane, Ammonium Acryloyldimethyltaurate/VP Copolymer, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Aluminum Hydroxide, Stearic Acid, Isohexadecane, Dimethicone/Vinyl Dimethicone Crosspolymer, Tocopheryl Acetate, Allantoin, Sorbitan Isostearate, Citrus Limon (Lemon) Peel Oil, Ethylhexylglycerin, Polysorbate 80,
Sorbitan Oleate, Xanthan Gum, Sophora Japonica Fruit Extract, Propolis Extract, Pancratium Maritimum Extract, Fomes Officinalis (Mushroom) Extract, Royal Jelly Extract, Honey Extract

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:

For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. If any adverse reaction occurs, stop using the product and consult with dermatologist if symptoms persist. Do not use on deep puncture wounds, animal bites or serious burns. Replace the cap after use. Keep out of reach of children. Keep out of direct sunlight.

DESCRIPTION

Uses
■ Helps prevent skin from excessive exposure to UV rays
■ Helps moisturize and refresh your skin that is easy to be dehydrated under the sun for long hours
■ Provides a gentle application without greasy or sticky feeling

Directions
■ For face, apply a dime-sized amount liberally and gently over your entire skin before sun exposure after your ritual daily moisturization.
■ For body, apply liberally and uniformly to any exposed areas of your body before sun exposure or long-hour outdoor activities to ensure sun protection.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

PAPA RECIPE HONEY MOIST SUN ESSENCE 
octinoxate, homosalate, octisalate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73020-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate3.50 g  in 50 mL
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate1.50 g  in 50 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate1.50 g  in 50 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.74 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Alcohol (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73020-050-021 in 1 CARTON03/01/2019
1NDC:73020-050-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/2019
Labeler - Costory Co., Ltd (694893916)
Registrant - Costory Co., Ltd (694893916)
Establishment
NameAddressID/FEIBusiness Operations
EYESOME. Co.,Ltd.557795360manufacture(73020-050)

Revised: 5/2019
Document Id: 66d3862d-9167-4163-a8a5-cf27df53942d
Set id: 787794a9-6221-427b-9676-3d6e48dd97e1
Version: 1
Effective Time: 20190509
 
Costory Co., Ltd