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NDC 81540-0020-02 BRING GREEN Tea Tree Tone Up Sun Cushion .9; 1.72 g/15g; g/15g Details

BRING GREEN Tea Tree Tone Up Sun Cushion .9; 1.72 g/15g; g/15g

BRING GREEN Tea Tree Tone Up Sun Cushion is a TOPICAL POWDER in the HUMAN OTC DRUG category. It is labeled and distributed by CJ Olive Young Corporation. The primary component is TITANIUM DIOXIDE; ZINC OXIDE.

Product Information

NDC	81540-0020
Product ID	81540-020_505452f0-d006-405b-ac1d-2cb066bb3570
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 Tone Up Sun Cushion
Proprietary Name Suffix	n/a
Non-Proprietary Name	ZINC OXIDE, TITANIUM DIOXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	POWDER
Route	TOPICAL
Active Ingredient Strength	.9; 1.72
Active Ingredient Units	g/15g; g/15g
Substance Name	TITANIUM DIOXIDE; ZINC OXIDE
Labeler Name	CJ Olive Young Corporation
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2022-12-31

Package

Package Images

NDC 81540-0020-02 (81540002002)

Pricing Information	N/A
NDC Package Code	81540-020-02
Billing NDC	81540002002
Package	1 CONTAINER in 1 CARTON (81540-020-02) / 15 g in 1 CONTAINER (81540-020-01)
Marketing Start Date	2021-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c800da61-7f05-406f-ad8d-7c15190f6626 Details

ACTIVE INGREDIENTS

ZINC OXIDE 11.50%

TITANIUM DIOXIDE 6.00%

INACTIVE INGREDIENTS

WATER, C12-15 ALKYL BENZOATE, CAPRYLYL METHICONE, BUTYLENE GLYCOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF WATER, NIACINAMIDE, METHYL TRIMETHICONE, MAGNESIUM SULFATE, METHYL METHACRYLATE CROSSPOLYMER, DIISOSTEARYL MALATE, ALUMINUM HYDROXIDE, STEARIC ACID, TRIETHOXYCAPRYLYLSILANE, POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE, GLYCERYL CAPRYLATE, CAPRYLYL GLYCOL, POLYGLYCERYL-6 POLYRICINOLEATE, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, ETHYLHEXYLGLYCERIN, DISTEARDIMONIUM HECTORITE, 1,2-HEXANEDIOL, MELIA AZADIRACHTA LEAF EXTRACT, MELIA AZADIRACHTA FLOWER EXTRACT, ADENOSINE, COCCINIA INDICA FRUIT EXTRACT, AMBER POWDER, SOLANUM MELONGENA (EGGPLANT) FRUIT EXTRACT, CURCUMA LONGA (TURMERIC) ROOT EXTRACT, OCIMUM SANCTUM LEAF EXTRACT, MORINGA OLEIFERA SEED OIL, CORALLINA OFFICINALIS EXTRACT, TOCOPHEROL, CALAMINE, CHLORELLA VULGARIS POWDER, SACCHAROMYCES FERMENT FILTRATE, CRYPTOMERIA JAPONICA LEAF EXTRACT, NELUMBO NUCIFERA LEAF 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

Directions

■ Press the sponge with the puff to pick up product, then evenly apply on areas exposed to sun.

■ Apply every 2-3 hours for outdoor activity.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BRING GREEN TEA TREE TONE UP SUN CUSHION

zinc oxide, titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81540-020
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	1.72 g in 15 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.9 g in 15 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:81540-020-02	1 in 1 CARTON	05/01/2021
1	NDC:81540-020-01	15 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	05/01/2021

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(81540-020)

Revised: 6/2021

Document Id: 505452f0-d006-405b-ac1d-2cb066bb3570

Set id: c800da61-7f05-406f-ad8d-7c15190f6626

Version: 1

Effective Time: 20210604