PAPA RECIPE HONEY MOIST SUN ESSENCE- octinoxate, homosalate, octisalate, titanium dioxide cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)
Available from:
Costory Co., Ltd
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose: Sunscreen
Authorization status:
OTC monograph not final
Authorization number:
73020-050-01, 73020-050-02

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.

----------

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

PAPA RECIPE HONEY MOIST SUN ESSENCE

Costory Co., Ltd

octinoxate, homosalate, octisalate, titanium dioxide cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:730 20 -0 50

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O ctino xa te (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

O c tino xa te

3.50 g in 50 mL

Ho mo sa la te (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S)

Ho mo sa la te

1.50 g in 50 mL

O ctisa la te (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

O c tisa la te

1.50 g in 50 mL

Tita nium Dio xide (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

Titanium Dio xide

0 .74 g in 50 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

Alco ho l (UNII: 3K9 9 58 V9 0 M)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End Date

1

NDC:730 20 -0 50 -

1 in 1 CARTON

0 3/0 1/20 19

1

NDC:730 20 -0 50 -

50 mL in 1 CONTAINER; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 3/0 1/20 19

Labeler -

Costory Co., Ltd (694893916)

Registrant -

Costory Co., Ltd (694893916)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

EYESOME. Co .,Ltd.

55779 536 0

ma nufa c ture (730 20 -0 50 )

Revised: 5/2019

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