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NDC 81540-0030-02 ROUNDAROUND GRRENTEA CICA SUN ZINC OXIDE 17 g/100mL Details

ROUNDAROUND GRRENTEA CICA SUN ZINC OXIDE 17 g/100mL

ROUNDAROUND GRRENTEA CICA SUN ZINC OXIDE is a TOPICAL LOTION 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	81540-0030
Product ID	81540-030_db230e10-f5f2-4bcd-850d-aadbee353507
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	ROUNDAROUND GRRENTEA CICA SUN ZINC OXIDE
Proprietary Name Suffix	n/a
Non-Proprietary Name	ZINC OXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
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	2022-12-31

Package

Package Images

NDC 81540-0030-02 (81540003002)

Pricing Information	N/A
NDC Package Code	81540-030-02
Billing NDC	81540003002
Package	1 BOTTLE in 1 CARTON (81540-030-02) / 100 mL in 1 BOTTLE (81540-030-01)
Marketing Start Date	2021-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ea872204-75e8-430c-aeb7-d1887941e4c0 Details

ACTIVE INGREDIENTS

ZINC OXIDE 17.00%

INACTIVE INGREDIENTS

WATER, CYCLOHEXASILOXANE, BUTYLOCTYL SALICYLATE, PROPANEDIOL, PROPYLHEPTYL CAPRYLATE, ISODODECANE, POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, DICAPRYLYL CARBONATE, CAPRYLYL METHICONE, METHYL METHACRYLATE CROSSPOLYMER, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, TRIETHOXYCAPRYLYLSILANE, 1,2-HEXANEDIOL, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, POLYMETHYLSILSESQUIOXANE, LAURYL POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL, CITRUS AURANTIUM DULCIS (ORANGE) OIL, GLYCERYL CAPRYLATE, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, CITRUS NOBILIS (MANDARIN ORANGE) PEEL OIL, SODIUM HYALURONATE, LITSEA CUBEBA FRUIT OIL, TOCOPHEROL, MADECASSOSIDE, BUTYLENE GLYCOL, DIPROPYLENE GLYCOL, CAMELLIA SINENSIS LEAF EXTRACT, CENTELLA ASIATICA LEAF EXTRACT, CENTELLA ASIATICA EXTRACT, MENTHA AQUATICA 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

■ As the final step of your skin care regimen, apply to areas easy to be exposed to UV rays,including face and neck.

■ Apply every 2-3 hours for outdoor activity.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROUNDAROUND GRRENTEA CICA SUN ZINC OXIDE

zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81540-030
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)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:81540-030-02	1 in 1 CARTON	05/01/2021
1	NDC:81540-030-01	100 mL in 1 BOTTLE; 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(81540-030)

Revised: 7/2021

Document Id: db230e10-f5f2-4bcd-850d-aadbee353507

Set id: ea872204-75e8-430c-aeb7-d1887941e4c0

Version: 2

Effective Time: 20210716