BOTANIC HEAL BOH DERMA WATER CERAMIDE AMPOULE CUSHION 01 NATURAL IVORY- titanium dioxide, octinoxate, octisalate powder

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

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Active ingredient:
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP), Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)
Available from:
Cj Olivenetworks Co., Ltd
INN (International Name):
Titanium Dioxide
Composition:
Titanium Dioxide 1.22 g in 10 g
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose: Sunscreen
Authorization status:
OTC monograph not final
Authorization number:
71596-030-01, 71596-030-02

BOTANIC HEAL BOH DERMA WATER CERAMIDE AMPOULE CUSHION 01 NATURAL

IVORY- titanium dioxide, octinoxate, octisalate powder

Cj Olivenetworks 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: Titanium Dioxide 12.24%, Ethylhexyl Methoxycinnamate 6.70%, Ethylhexyl

Salicylate 4.0%

INACTIVE INGREDIENT

Inactive ingredients: Water, Methyl Trimethicone ,Cyclopentasiloxane,Glycerin,Lauryl PEG-10

Tris(Trimethylsiloxy)silylethyl Dimethicone,Dimethicone,Butylene Glycol,Niacinamide,Pentylene

Glycol,Phenyl Trimethicone,Synthetic Fluorphlogopite,Butylene Glycol Dicaprylate/Dicaprate,Methyl

Methacrylate Crosspolymer,PEG-10 Dimethicone,Iron Oxides (CI 77492),Trisiloxane,Magnesium

Sulfate,Phenoxyethanol,C30-45 Alkyl Cetearyl Dimethicone Crosspolymer,Acrylates/Stearyl

Acrylate/Dimethicone Methacrylate Copolymer,Disteardimonium Hectorite,Stearic

Acid,Alumina,Triethoxycaprylylsilane,Iron Oxides (CI 77491),Aluminum Hydroxide,Dimethicone

Crosspolymer,Fragrance(Parfum),Caprylic/Capric Triglyceride,Ethylhexylglycerin,Iron Oxides (CI

77499),Hydrogenated Lecithin,Adenosine,Hydrogenated Castor Oil Isostearate,Disodium

EDTA,Ceramide NP,Aloe Ferox Leaf Extract,Nelumbo Nucifera Flower

Water,Xylitylglucoside,Anhydroxylitol,Hyaluronic Acid,Hydrolyzed Hyaluronic Acid,Sodium

Hyaluronate,Xylitol

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or

rashes appear. Replace the cap after use. Keep Out of Reach of Children.

DESCRIPTION

Uses: The smart water cushion contains ampoule compounds, leaving skin moist and well-hydrated with

a beautiful 3-D effect.

Directions: Squeeze a moderate amount on a puff and apply to face along with the skin texture evenly as

a foundation and gently stroke to get it absorbed. Apply over as frequently as required.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BOTANIC HEAL BOH DERMA WATER CERAMIDE AMPOULE CUSHION 01

NATURAL IVORY

titanium dioxide, octinoxate, octisalate powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7159 6 -0 30

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

Titanium Dio xide

1.22 g in 10 g

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

O c tino xa te

0 .6 7 g in 10 g

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

O c tisa la te

0 .40 g in 10 g

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7159 6 -0 30 -0 2 2 in 1 CARTON

0 7/0 1/20 17

1

NDC:7159 6 -0 30 -0 1 10 g in 1 CONTAINER; Type 0 : No t a Co mbinatio n Pro duct

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 7/0 1/20 17

Labeler -

Cj Olivenetworks Co., Ltd (688271303)

Registrant -

Cj Olivenetworks Co., Ltd (688271303)

Establishment

Cj Olivenetworks Co., Ltd

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Co smax, Inc

6 8 9 0 49 6 9 3

ma nufa c ture (7159 6 -0 30 )

Revised: 8/2017

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