DrugInserts.com

Over the Counter Medications

SUPER LIGHT TOUCH BB SPF30 PA PLUS PLUS: Package Insert and Label Information

SUPER LIGHT TOUCH BB SPF30 PA PLUS PLUS- titanium dioxide and zinc oxide cream
HANSKIN 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.

ACTIVE INGREDIENT

Active Ingredients: Titanium Dioxide 10.44%, Zinc Oxide 1.44%

INACTIVE INGREDIENT

Inactive Ingredients:
Water, Cyclopentasiloxane, Arbutin, Dimethicone, Butylene Glycol Dicaprylate/Dicaprate, Butylene Glycol, Cyclohexasiloxane, Glycerin, Orbignya Oleifera Seed Oil, Magnesium Sulfate, Lecithin, Disteardimonium Hectorite, Dipropylene Glycol, Polyglutamic Acid, Talc, Adenosine, Dimethicone/Vinyl Dimethicone Crosspolymer, Ozokerite, Calcium Stearate, Diisostearyl Malate, Hexyl Laurate, Beeswax, Polyglyceryl-4 Isostearate, Silica, Sorbitan Olivate, Sorbitan Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Propylene Carbonate, Propylene Glycol Stearate, Sorbitan Laurate, Triethoxycaprylylsilane, Polysorbate 20, Propylene Glycol Laurate, Hydrogen Dimethicone, Pentaerythrityl tetraisostearate, Stearalkonium hectorite, Palmitoyl dipeptide-10, Palmitoyl tripeptide-1, Polyhydroxystearic Acid, Isopropyl Palmitate, Isostearic Acid, Ethylhexyl Palmitate, Polyglyceryl-3 Polyricinoleate, Fagus Sylvatica Bud Extract, Alpinia Officinarum Root Extract, Lactobacillus/Nelumbo Nucifera Seed Ferment Filtrate, Abies Koreana Leaf Extract, Terminalia Chebula Fruit Extract, Urea, Yeast Amino Acids, Taurine, Trehalose, Betaine, Inositol, Caprylic/Capric Triglyceride, Coco-Caprylate/Caprate, Hydrogenated Lecithin, Cetyl Phosphate, Sodium Ascorbyl Phosphate, Butyrospermum Parkii (Shea Butter), Citric Acid, Hydrolyzed Hyaluronic Acid, Zea Mays (Corn) Kernel Extract, Disodium EDTA, Phenoxyethanol, Propylparaben, Methylparaben

PURPOSE

Purpose: Makeup preparation, Blemish coverage, Skin protection, Anti-wrinkle, Whitening

WARNINGS

WARNINGS:
1. Stop using it immediately if red rash, swollenss, itching or other symptoms develops.
Consult with the dermotologist if symptoms stay.
2. Do not use it on the part where you have a scar, eczema, or dermatitis.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN:
Keep out of reach of babies and children.

INDICATIONS AND USAGE

INDICATIONS AND USAGE:
Tighten the lid after using it.
Keep in normal room temperature and avoid direct sunlight.

DOSAGE AND ADMINISTRATION

DOSAGE AND ADMINISTRATION:
After skin care routines, apply appropriate amount (1-2 waterdrop size) on your face and spread evenly and smoothly.
Apply powder and finish with point makeup if necessary.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

Image of carton
(click image for full-size original)

SUPER LIGHT TOUCH BB SPF30 PA PLUS PLUS
titanium dioxide, zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:47469-120
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium Dioxide (TITANIUM DIOXIDE) TITANIUM DIOXIDE 3.13 g in 30 mL
Zinc Oxide (ZINC OXIDE) ZINC OXIDE 0.43 g in 30 mL
Inactive Ingredients
Ingredient Name Strength
Water
Dimethicone
Butylene Glycol
Glycerin
Arbutin
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47469-120-01 30 mL in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 03/01/2012
Labeler — HANSKIN CO., LTD. (690306386)
Registrant — HANSKIN CO., LTD. (690306386)
Establishment
Name Address ID/FEI Operations
HANSKIN CO., LTD. 690306386 manufacture (47469-120)

Revised: 10/2012 HANSKIN CO., LTD.