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NDC 81540-0080-02 BRING GREEN Tea Tree CICA Cooling Sun 1.5; 3.5; 3; 2 g/100g; g/100g; g/100g; g/100g Details

BRING GREEN Tea Tree CICA Cooling Sun 1.5; 3.5; 3; 2 g/100g; g/100g; g/100g; g/100g

BRING GREEN Tea Tree CICA Cooling Sun is a TOPICAL STICK in the HUMAN OTC DRUG category. It is labeled and distributed by CJ Olive Young Corporation. The primary component is BEMOTRIZINOL; DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE; ETHYLHEXYL TRIAZONE; POLYSILICONE-15.

Product Information

NDC	81540-0080
Product ID	81540-080_eb8316f9-bca3-42ae-80a0-6f033a829846
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	BRING GREEN Tea Tree CICA Cooling Sun
Proprietary Name Suffix	n/a
Non-Proprietary Name	DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, ETHYLHEXYL TRIAZONE, POLYSILICONE 15, BEMOTRIZINOL
Product Type	HUMAN OTC DRUG
Dosage Form	STICK
Route	TOPICAL
Active Ingredient Strength	1.5; 3.5; 3; 2
Active Ingredient Units	g/100g; g/100g; g/100g; g/100g
Substance Name	BEMOTRIZINOL; DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE; ETHYLHEXYL TRIAZONE; POLYSILICONE-15
Labeler Name	CJ Olive Young Corporation
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2023-12-31

Package

Package Images

NDC 81540-0080-02 (81540008002)

Pricing Information	N/A
NDC Package Code	81540-080-02
Billing NDC	81540008002
Package	1 CONTAINER in 1 CARTON (81540-080-02) / 22 g in 1 CONTAINER (81540-080-01)
Marketing Start Date	2022-08-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 2a16263a-a33c-4ef5-b7bf-129d36a7eb88 Details

ACTIVE INGREDIENTS

DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE 3.5%

ETHYLHEXYL TRIAZONE 3.0%

POLYSILICONE-15 2.0%

BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE 1.5%

INACTIVE INGREDIENTS

WATER, SYNTHETIC WAX, C12-15 ALKYL BENZOATE, DIBUTYL ADIPATE, BUTYLOCTYL SALICYLATE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, BUTYLENE GLYCOL, NIACINAMIDE, OZOKERITE, VINYL DIMETHICONE, POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE, TITANIUM DIOXIDE, SODIUM CHLORIDE, LAURYL POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, COCO-CAPRYLATE/CAPRATE, GLYCERYL CAPRYLATE, CAPRYLYL GLYCOL, SORBITAN SESQUIOLEATE, POLYHYDROXYSTEARIC ACID, CENTELLA ASIATICA EXTRACT, ETHYLHEXYLGLYCERIN, 1,2-HEXANEDIOL, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, ADENOSINE, ALUMINUM HYDROXIDE, TRIETHOXYCAPRYLYLSILANE, MELALEUCA ALTERNIFOLIA (TEA TREE) EXTRACT, MELIA AZADIRACHTA LEAF EXTRACT, MELIA AZADIRACHTA FLOWER EXTRACT, COCCINIA INDICA FRUIT EXTRACT, SOLANUM MELONGENA (EGGPLANT) FRUIT EXTRACT, ALOE BARBADENSIS FLOWER EXTRACT, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, CURCUMA LONGA (TURMERIC) ROOT EXTRACT, CORALLINA OFFICINALIS EXTRACT, OCIMUM SANCTUM LEAF EXTRACT, TOCOPHEROL, MADECASSOSIDE, MELALEUCA ALTERNIFOLIA (TEA TREE) FLOWER/LEAF/STEM EXTRACT

PURPOSE

Sunscreen

WARNINGS

■ FOR EXTERNAL USE ONLY

■ If you experience any symptoms such as redness, swelling or itchiness during usage or from exposure to direct sunlight after usage, suspend use and consult a physician

■ Do not use on wounds or other areas of skin irritation

■ Keep out of reach of children

■ Keep away from direct sunlight

KEEP OUT OF REACH OF CHILDREN

■ Keep out of reach of children.

Uses

■ Helps prevent sunburn

■ Higher SPF gives more sunburn protection

■ Proven mild formulation that doesn't cause skin irritation

■ The low-irritant sun cream that soothes the sensitive skin and protects skin from sun exposure with lightweight and fast-absorbing formula

■ This contains tea tree flower/leaf/stem extract and leaf oil and centella asiatica extract

Directions

■ Apply liberally to your face and neck.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BRING GREEN TEA TREE CICA COOLING SUN

diethylamino hydroxybenzoyl hexyl benzoate, ethylhexyl triazone, polysilicone 15, bemotrizinol stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81540-080
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20) (DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE - UNII:ANQ870JD20)	DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE	3.5 g in 100 g
ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4) (ETHYLHEXYL TRIAZONE - UNII:XQN8R9SAK4)	ETHYLHEXYL TRIAZONE	3.0 g in 100 g
POLYSILICONE-15 (UNII: F8DRP5BB29) (POLYSILICONE-15 - UNII:F8DRP5BB29)	POLYSILICONE-15	2.0 g in 100 g
BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH)	BEMOTRIZINOL	1.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIBUTYL ADIPATE (UNII: F4K100DXP3)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:81540-080-02	1 in 1 CARTON	08/01/2022
1	NDC:81540-080-01	22 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
unapproved drug other		08/01/2022

Labeler - CJ Olive Young Corporation (695640147)

Registrant - CJ Olive Young Corporation (695640147)

Name	Address	ID/FEI	Business Operations
Establishment
Kolmar Korea Co.,LTD. Gwanjeong Factory		689512611	manufacture(81540-080)

Revised: 8/2022

Document Id: eb8316f9-bca3-42ae-80a0-6f033a829846

Set id: 2a16263a-a33c-4ef5-b7bf-129d36a7eb88

Version: 2

Effective Time: 20220824