Otc - Active Ingredient
ZINC OXIDE 20.3%
TITANIUM DIOXIDE 10%
U V-lamp Shield Mani-sunscreen Liquid
FDA Label NDC 85966-004
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 U V-lamp Shield Mani-sunscreen (NDC 85966-004). 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
Helps prevent sunburn.
lf used as directed with other sun protection measures (see DIRECTIONS), decreases the risk of skin cancer and early skin agingcaused by the sun
Desiqned to create a breathable barrier to shield hands from UVA and UVB radiation emitted during gel nail curing.
Warnings
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 a doctor if · Rash occurs.
Keep out of reach of children. For external use only.
UV Lamp Specific Warning ·For maximum protection, reapply after hand washing or sweating during nail services.
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 to remove.
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.
Dosage & Administration
1. Clean and dry your hands with thoroughly.
2. Apply a pearl-sized amountand spread evenly over hands, avoiding nails and cuticles.
3. Wait 5s for theproduct to form a matte film before beginning your nail art beauty.
4. Afternail lamp curing, simply wipe or rinse off any residue.
Tip: This sunscreen can also be applied daily for general U V protection. Forprolonged UV exposure (e.g., at a nail salon), reapply every 2 hours.
Inactive Ingredient
ROSA DAMASCENA FLOWER WATER
BUTYLENE GLYCOL
HYDROXYACETOPHENONE
MAGNESIUM SULFATE
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
TOCOPHEROL
PEG-10 DIMETHICONE
C12-15 ALKYL BENZOATE
POLYHYDROXYSTEARIC ACID
TRIETHOXYCAPRYLYLSILANE
ALUMINUM HYDROXIDE
STEARIC ACID
CYCLOPENTASILOXANE
DISTEARDIMONIUM HECTORITE
DIMETHICONE
PHENYL TRIMETHICONE
SILICA
POLYMETHYLSILSESQUIOXANE
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
Package Label.Principal Display Panel
Label (Label)
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