BOTANIC HEAL BOH DUAL PRIMER SUN NO 1- octocrylene, octinoxate, octisalate, titanium dioxide stick
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: OCTOCRYLENE 9.00%, ETHYLHEXYL METHOXYCINNAMATE 7.00%, ETHYLHEXYL SALICYLATE 4.50%, TITANIUM DIOXIDE 2.94%

INACTIVE INGREDIENT

Inactive ingredients: SILICA,CERESIN,DICAPRYLYL CARBONATE, PHENYL TRIMETHICONE,ISOPROPYL PALMITATE,CETEARYL ETHYLHEXANOATE,STEARYL HEPTANOATE, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE,MICA,BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE,TOCOPHERYL ACETATE,MICROCRYSTALLINE WAX,DIMETHICONE,ALUMINUM DISTEARATE,SYNTHETIC FLUORPHLOGOPITE,BISABOLOL,HYDROXYACETOPHENONE,LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE,FRAGRANCE,POLYURETHANE-11,TRIETHOXYCAPRYLYLSILANE,IRON OXIDES(CI 77491),ACRYLATES/TRIDECYL ACRYLATE/TRIETHOXYSILYLPROPYL METHACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER,TOCOPHEROL,MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL

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: Primer sun stick keeps skin feeling smooth for long hours and perfectly blocks UV rays.

Directions: At the last step of basic skincare, turn the dial on the lower part of the container to raise content by 5mm and lightly apply on the face, starting from the inside and working outward.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

BOTANIC HEAL BOH DUAL PRIMER SUN NO 1
octocrylene, octinoxate, octisalate, titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71596-043
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.99 g in 11 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.77 g in 11 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.49 g in 11 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.32 g in 11 g

Ingredient Name	Strength
Inactive Ingredients
CERESIN (UNII: Q1LS2UJO3A)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71596-043-02	1 in 1 CARTON	07/01/2017	12/30/2019
1	NDC:71596-043-01	11 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	07/01/2017	12/30/2019

Labeler - Cj Olivenetworks Co., Ltd (688271303)

Registrant - Cj Olivenetworks Co., Ltd (688271303)

Name	Address	ID/FEI	Business Operations
Establishment
Kolmar Korea Co.,LTD. Gwanjeong Factory		689512611	manufacture(71596-043)

Revised: 7/2021

Document Id: e7be6b30-036c-4543-a9b6-2dfed479fe0f

Set id: 833d66b8-f089-49bd-8c12-07ec08f664ef

Version: 2

Effective Time: 20210702

Cj Olivenetworks Co., Ltd