Otc - Active Ingredient
ZINC OXIDE
TITANIUM DIOXIDE
Pure6 Manishield Hand Screen Liquid
FDA Label NDC 85966-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Saweilan Import & Export Trading Co., Ltd for the product Pure6 Manishield Hand Screen (NDC 85966-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - When Using
When using this product, keep out of eyes, Rinse with water toremove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs.
Otc - 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
Package Label.Principal Display Panel
Label2 (Label2)
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