PURE6 MANISHIELD HAND SCREEN- zinc oxide, titanium dioxide liquid

Pure6 ManiShield Hand Screen by

Drug Labeling and Warnings

Pure6 ManiShield Hand Screen by is a Otc medication manufactured, distributed, or labeled by GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ZINC OXIDE
TITANIUM DIOXIDE

PURPOSE

Sunscreen

INDICATIONS & USAGE

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.

WARNINGS

1. For external use only

DO NOT USE

Do not use on damaged or broken skin.

WHEN USING

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

STOP USE

Stop use and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

. 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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PURE6 MANISHIELD HAND SCREEN 
zinc oxide, titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85966-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	10 g  in 50 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.5 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHENYLALANINE (UNII: 47E5O17Y3R)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
NIACINAMIDE (UNII: 25X51I8RD4)
SQUALANE (UNII: GW89575KF9)
THREONINE (UNII: 2ZD004190S)
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
LYSINE (UNII: K3Z4F929H6)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
VALINE (UNII: HG18B9YRS7)
PHOSPHOLIPID PHOSPHATASE 1 (UNII: IP029363WQ)
POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATE (UNII: X2PZH4Y6HT)
BISABOLOL (UNII: 24WE03BX2T)
STEARIC ACID (UNII: 4ELV7Z65AP)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SERINE (UNII: 452VLY9402)
SODIUM (UNII: 9NEZ333N27)
PROLINE (UNII: 9DLQ4CIU6V)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
WATER (UNII: 059QF0KO0R)
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
ARGININE (UNII: 94ZLA3W45F)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
ECTOIN (UNII: 7GXZ3858RY)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)
HISTIDINE (UNII: 4QD397987E)
COCOS NUCIFERA (COCONUT) OIL (UNII: Q9L0O73W7L)
LEUCINE (UNII: GMW67QNF9C)
CERAMIDE NP (UNII: 4370DF050B)
GLYCINE (UNII: TE7660XO1C)
GLUTAMIC ACID (UNII: 3KX376GY7L)
RESVERATROL (UNII: Q369O8926L)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
MICROCOCCUS LUTEUS (UNII: LV6L29Z6AX)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CHRYSANTHELLUM INDICUM FLOWER OIL (UNII: HJ299SUZ05)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
TYROSINE (UNII: 42HK56048U)
SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
ASPARTIC ACID (UNII: 30KYC7MIAI)
ALANINE (UNII: OF5P57N2ZX)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
ERGOTHIONEINE (UNII: BDZ3DQM98W)
PANTHENOL (UNII: WV9CM0O67Z)
TOCOPHEROL (UNII: R0ZB2556P8)
ISOLEUCINE (UNII: 04Y7590D77)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85966-002-01	50 g in 1 BOTTLE; Type 0: Not a Combination Product	07/25/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/25/2025

Labeler - GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD (847858432)

Establishment
Name	Address	ID/FEI	Business Operations
GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD		847858432	manufacture(85966-002)