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NDC 81540-0040-02 BRINGGREEN Tea Tree CICA Soothing Sun 17 g/100mL Details

BRINGGREEN Tea Tree CICA Soothing Sun 17 g/100mL

BRINGGREEN Tea Tree CICA Soothing Sun is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by CJ Olive Young Corporation. The primary component is ZINC OXIDE.

Product Information

NDC	81540-0040
Product ID	81540-040_8a77b683-b5f2-46ff-bb49-ca5624789947
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	BRINGGREEN Tea Tree CICA Soothing Sun
Proprietary Name Suffix	n/a
Non-Proprietary Name	ZINC OXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	17
Active Ingredient Units	g/100mL
Substance Name	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	2023-12-31

Package

Package Images

NDC 81540-0040-02 (81540004002)

Pricing Information	N/A
NDC Package Code	81540-040-02
Billing NDC	81540004002
Package	1 CONTAINER in 1 CARTON (81540-040-02) / 50 mL in 1 CONTAINER (81540-040-01)
Marketing Start Date	2022-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 189ce7a9-cc0a-4919-a416-1740ba3a2f7d Details

ACTIVE INGREDIENT

ZINC OXIDE 17.0%

INACTIVE INGREDIENTS

WATER, CYCLOHEXASILOXANE, DIPROPYLENE GLYCOL, BUTYLOCTYL SALICYLATE, PROPANEDIOL, ISODODECANE, POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, DICAPRYLYL CARBONATE, PROPYLHEPTYL CAPRYLATE, NIACINAMIDE, CAPRYLYL METHICONE, POLYPROPYLSILSESQUIOXANE, METHYL METHACRYLATE CROSSPOLYMER, CALCIUM ALUMINUM BOROSILICATE, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, TRIETHOXYCAPRYLYLSILANE, 1,2-HEXANEDIOL, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, LAURYL POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, GLYCERYL CAPRYLATE, CENTELLA ASIATICA EXTRACT, CAPRYLYL GLYCOL, BUTYLENE GLYCOL, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, ETHYLHEXYLGLYCERIN,ADENOSINE, MELALEUCA ALTERNIFOLIA (TEA TREE) EXTRACT, SODIUM HYALURONATE, 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 an appropriate amount evenly for the last step of skin care

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BRINGGREEN TEA TREE CICA SOOTHING SUN

zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81540-040
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	17 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
DIPROPYLENE GLYCOL (UNII: E107L85C40)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:81540-040-02	1 in 1 CARTON	05/01/2022
1	NDC:81540-040-01	50 mL 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	05/01/2022

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(81540-040)

Revised: 6/2022

Document Id: 8a77b683-b5f2-46ff-bb49-ca5624789947

Set id: 189ce7a9-cc0a-4919-a416-1740ba3a2f7d

Version: 1

Effective Time: 20220603