Pure6 ManiShield Hand Screen

85966-002 Pure6 ManiShield Hand Screen

Approved

Approval ID

3abcb6ba-1de8-55e7-e063-6294a90aecf1

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 2, 2025

Manufacturers

FDA

GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD

DUNS: 847858432

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ZINC OXIDE, TITANIUM DIOXIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code85966-002

Application NumberM020

Product Classification

Marketing Category

C200263

Generic Name

ZINC OXIDE, TITANIUM DIOXIDE

Product Specifications

Route of AdministrationTOPICAL

Effective DateSeptember 2, 2025

FDA Product Classification

INGREDIENTS (61)

TRIETHOXYCAPRYLYLSILANEInactive

Code: LDC331P08E

Classification: IACT

ALUMINUM HYDROXIDEInactive

Code: 5QB0T2IUN0

Classification: IACT

SODIUM HYALURONATEInactive

Code: YSE9PPT4TH

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

PHENYLALANINEInactive

Code: 47E5O17Y3R

Classification: IACT

DICAPRYLYL CARBONATEInactive

Code: 609A3V1SUA

Classification: IACT

NIACINAMIDEInactive

Code: 25X51I8RD4

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SQUALANEInactive

Code: GW89575KF9

Classification: IACT

THREONINEInactive

Code: 2ZD004190S

Classification: IACT

CENTELLA ASIATICA WHOLEInactive

Code: 7M867G6T1U

Classification: IACT

LYSINEInactive

Code: K3Z4F929H6

Classification: IACT

ETHYLHEXYLGLYCERINInactive

Code: 147D247K3P

Classification: IACT

PHOSPHOLIPID PHOSPHATASE 1Inactive

Code: IP029363WQ

Classification: IACT

BUTYROSPERMUM PARKII (SHEA) BUTTERInactive

Code: K49155WL9Y

Classification: IACT

1,2-HEXANEDIOLInactive

Code: TR046Y3K1G

Classification: IACT

MICROCOCCUS LUTEUSInactive

Code: LV6L29Z6AX

Classification: IACT

VALINEInactive

Code: HG18B9YRS7

Classification: IACT

BISABOLOLInactive

Code: 24WE03BX2T

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATEInactive

Code: X2PZH4Y6HT

Classification: IACT

PENTYLENE GLYCOLInactive

Code: 50C1307PZG

Classification: IACT

PHENOXYETHANOLInactive

Code: HIE492ZZ3T

Classification: IACT

ZINC OXIDEActive

Quantity: 10 g in 50 g

Code: SOI2LOH54Z

Classification: ACTIB

POLYGLYCERYL-3 DIISOSTEARATEInactive

Code: 46P231IQV8

Classification: IACT

ARGININEInactive

Code: 94ZLA3W45F

Classification: IACT

STEARYL GLYCYRRHETINATEInactive

Code: 3YYE6VJS0P

Classification: IACT

CAPRYLIC/CAPRIC TRIGLYCERIDEInactive

Code: C9H2L21V7U

Classification: IACT

ECTOINInactive

Code: 7GXZ3858RY

Classification: IACT

HYDROXYACETOPHENONEInactive

Code: G1L3HT4CMH

Classification: IACT

GARDENIA TAITENSIS FLOWERInactive

Code: T0OCU8201Y

Classification: IACT

HISTIDINEInactive

Code: 4QD397987E

Classification: IACT

COCOS NUCIFERA (COCONUT) OILInactive

Code: Q9L0O73W7L

Classification: IACT

LEUCINEInactive

Code: GMW67QNF9C

Classification: IACT

CERAMIDE NPInactive

Code: 4370DF050B

Classification: IACT

SERINEInactive

Code: 452VLY9402

Classification: IACT

SODIUMInactive

Code: 9NEZ333N27

Classification: IACT

PROLINEInactive

Code: 9DLQ4CIU6V

Classification: IACT

GLYCINEInactive

Code: TE7660XO1C

Classification: IACT

GLUTAMIC ACIDInactive

Code: 3KX376GY7L

Classification: IACT

RESVERATROLInactive

Code: Q369O8926L

Classification: IACT

BUTYLENE GLYCOLInactive

Code: 3XUS85K0RA

Classification: IACT

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATEInactive

Code: 9229XJ4V12

Classification: IACT

TRIBEHENINInactive

Code: 8OC9U7TQZ0

Classification: IACT

CAPRYLYL GLYCOLInactive

Code: 00YIU5438U

Classification: IACT

PROPYLENE CARBONATEInactive

Code: 8D08K3S51E

Classification: IACT

SACCHARIDE ISOMERATEInactive

Code: W8K377W98I

Classification: IACT

BUTYLOCTYL SALICYLATEInactive

Code: 2EH13UN8D3

Classification: IACT

CHRYSANTHELLUM INDICUM FLOWER OILInactive

Code: HJ299SUZ05

Classification: IACT

POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)Inactive

Code: 59Z907ZB69

Classification: IACT

ALANINEInactive

Code: OF5P57N2ZX

Classification: IACT

PANTHENOLInactive

Code: WV9CM0O67Z

Classification: IACT

TITANIUM DIOXIDEActive

Quantity: 2.5 g in 50 g

Code: 15FIX9V2JP

Classification: ACTIB

TYROSINEInactive

Code: 42HK56048U

Classification: IACT

SCLEROCARYA BIRREA SEED OILInactive

Code: WDO4TLS35F

Classification: IACT

ISONONYL ISONONANOATEInactive

Code: S4V5BS6GCX

Classification: IACT

ASPARTIC ACIDInactive

Code: 30KYC7MIAI

Classification: IACT

TOCOPHEROLInactive

Code: R0ZB2556P8

Classification: IACT

ISOLEUCINEInactive

Code: 04Y7590D77

Classification: IACT

ERGOTHIONEINEInactive

Code: BDZ3DQM98W

Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/25/2025

label2

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/25/2025

Uses: Helps provide essential protection from UV LED nail lamps.When used as directed, it helps decrease the risk of skin damageandpremature aging caused by manicure light exposure.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/25/2025

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 7/25/2025

1. For external use only

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 7/25/2025

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 7/25/2025

When using this product, keep out of eyes, Rinse with water toremove.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 7/25/2025

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 7/25/2025

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/25/2025

ZINC OXIDE
TITANIUM DIOXIDE

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/25/2025

. For Manicure UV Protection: Apply a thick, even layer to hands right before U V curing. Pay special attention to the back of yourhands for essentialUVdefense.
Note: Avoid direct contact with nails. If contact occurs, wipe nailsclean with an alcohol pad before applying polish to ensure a fawless finish.
. For Daily Sun Protection: Apply liberally 15 minutes before sunexposure (e.g., before driving). To maintain optimal protection andhydration, reapply every 2 hours during sun exposure, and alwaysafter hand washing or heavy sweating. Use anytime as a nourishinghand cream.
.Sun Protection Measures: Spending time in the sun increases yourrisk of skin cancer and early skin aging. To decrease this risk,regularlyuse a sunscreen with a Broad Spectrum SPF value of 15 orhigher 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
.Childrenunder 6 months of age: Ask a doctor.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/25/2025

WATER
DICAPRYLYL CARBONATE
BUTYLENE GLYCOL
BUTYLOCTYL SALICYLATE
GLYCERIN
ISONONYL ISONONANOATE
POLYGLYCERYL-3 DIISOSTEARATE
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE
POLYMETHYLSILSESQUIOXANE
SODIUM CHLORIDE
TRIETHOXYCAPRYLYLSILANE
DISTEARDIMONIUM HECTORITE
ALUMINUM HYDROXIDE
STEARIC ACID
BUTYROSPERMUM PARKII (SHEA) BUTTER
NIACINAMIDE
CENTELLA ASIATICA LEAF EXTRACT
CHRYSANTHELLUM INDICUM FLOWER WATER
TRIBEHENIN
PHENOXYETHANOL
HYDROXYACETOPHENONE
1,2-HEXANEDIOL
PROPYLENE CARBONATE
PANTHENOL
TOCOPHEROL
BISABOLOL
STEARYL GLYCYRRHETINATE
SQUALANE
ECTOIN
ETHYLHEXYLGLYCERIN
SODIUM HYALURONATE
SCLEROCARYA BIRREA SEED OIL
COCOS NUCIFERA (COCONUT) OIL
SACCHARIDE ISOMERATE
CERAMIDE NP
MICROCOCCUS LYSATE
PENTYLENE GLYCOL
GLYCINE
GARDENIA TAITENSIS FLOWER EXTRACT
SERINE
GLUTAMIC ACID
SODIUM DNA
ERGOTHIONEINE
ASPARTIC ACID
LEUCINE
ALANINE
LYSINE
ARGININE
TYROSINE
PHENYLALANINE
PROLINE
THREONINE
VALINE
CAPRYLIC/CAPRIC TRIGLYCERIDE
ISOLEUCINE
CAPRYLYL GLYCOL
HISTIDINE
PHOSPHOLIPIDS
RESVERATROL

AI-Powered Research

Premium Access

Pure6 ManiShield Hand Screen

Products 1

ZINC OXIDE, TITANIUM DIOXIDE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (61)

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

WARNINGS SECTION

OTC - DO NOT USE SECTION

OTC - WHEN USING SECTION

OTC - STOP USE SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - ACTIVE INGREDIENT SECTION

DOSAGE & ADMINISTRATION SECTION

INACTIVE INGREDIENT SECTION

MedPath

Product

Company

Legal