SOQU Watery Chamomile Sun Cream by G1 BIO Co., Ltd. / COVIX Co., Ltd

SOQU Watery Chamomile Sun Cream by

Drug Labeling and Warnings

SOQU Watery Chamomile Sun Cream by is a Otc medication manufactured, distributed, or labeled by G1 BIO Co., Ltd., COVIX Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SOQU WATERY CHAMOMILE SUN CREAM- zinc oxide, titanium dioxide cream 
G1 BIO 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 ingredients

Titanium Dioxide 4.8%, Zinc Oxide 15%

Purpose

Sunscreen

Use

Helps prevent sunburn

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask doctor if rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

Apply liberally and evenly 15 minutes before sun exposure.

Children under 6 months of age: Ask a doctor.

Reapply at least every 2 hours.

Use a water-resistant sunscreen if swimming or sweating.

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

Limit time in the sun, especially from 10 a.m.-2 p.m.

Wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive ingredients

WATER, COCO-CAPRYLATE/CAPRATE, CYCLOMETHICONE 5, ALKYL (C12-15) BENZOATE, DIPROPYLENE GLYCOL, CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE, POLYHYDROXYSTEARIC ACID, 1,2-HEXANEDIOL, CETYL PEG/PPG-10/1 DIMETHICONE, CHAMOMILE, TRIETHOXYCAPRYLYLSILANE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, STEARALKONIUM HECTORITE, MAGNESIUM SULFATE ANHYDROUS, STEARIC ACID, ALUMINUM STEARATE, POLYGLYCERYL-3 RICINOLEATE, POLYGLYCERYL-3 DIISOSTEARATE, ALUMINUM HYDROXIDE, ETHYLHEXYLGLYCERIN, EDETATE DISODIUM, PROPYLENE CARBONATE, POLYMETHYLSILSESQUIOXANE, PENTYLENE GLYCOL, CENTELLA ASIATICA WHOLE, GLYCERIN, EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP, ANHYDROUS CITRIC ACID

SOQU Watery Chamomile Sun Cream

SOQU WATERY CHAMOMILE SUN CREAM 
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82147-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5.2515 g  in 35.01 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.68048 g  in 35.01 g

Inactive Ingredients
Ingredient Name	Strength
CHAMOMILE (UNII: FGL3685T2X)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
WATER (UNII: 059QF0KO0R)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)
GLYCERIN (UNII: PDC6A3C0OX)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82147-201-02	1 in 1 BOX	08/10/2021	05/30/2022
1	NDC: 82147-201-01	35.01 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/10/2021	05/30/2022

Labeler - G1 BIO Co., Ltd. (694622746)

Establishment
Name	Address	ID/FEI	Business Operations
COVIX Co., Ltd		688427719	manufacture(82147-201)

Revised: 12/2022

Document Id: f0b63a96-d0be-8e2e-e053-2a95a90a520c

34390-5

Set id: c92afdd7-ad68-cda0-e053-2995a90a6bd2

Version: 2

Effective Time: 20221226