PURLISSE BB TINTED MOIST SPF30 FAIR- octinoxate, titanium dioxide, zinc oxide cream 
BONNE 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.

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ACTIVE INGREDIENT

Active Ingredients: Ethylhexyl Methoxycinnamate 6.5%, Titanium Dioxide 4.24%, Zinc Oxide 3.5%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Cyclopentasiloxane, Butylene Glycol, Caprylic/Capric Triglyceride, Cetyl PEG/PPG-10/1 Dimethicone, Sorbitan Sesquioleate, Dimethicone, Sodium Chloride, Beeswax, Magnesium Aluminum Silicate, Stearalkonium Hectorite, Iron Oxide(CI 77492), Phenoxyethanol, Dimethicone/ vinyl Dimethicone Crosspolymer, Ozokerite, Iron Oxide(CI 77491), PEG-10 Dimethicone Crosspolymer, Cyclotetrasiloxane, Iron Oxide(CI 77499), Artemisia Absinthium Extract, Chamomilla Recutita (Matricaria) Flower Extract, Gentiana Lutea Root Extract, Portulaca Oleracea Extract, Acer Saccharum (Sugar Maple) Extract

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: For external use only • 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. If product is swallowed, get medical help or contact a Poison Control Center right away

DESCRIPTION

Uses: Use helps prevent sunburn

Directions: For sunscreen use: • apply liberally and evenly 15 minutes before sun exposure • reapply at least every two hours • use a water resistant sunscreen if swimming or sweating • Sun Protection Measure: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a Broad Spectrum SPF value of 15 or higher 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 • children under 6 months of age: Ask doctor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

PURLISSE BB TINTED MOIST SPF30 FAIR 
octinoxate, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69997-120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate2.6 g  in 40 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.69 g  in 40 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.4 g  in 40 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69997-120-021 in 1 CARTON06/01/201706/29/2018
1NDC:69997-120-0140 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/201706/29/2018
Labeler - BONNE CO.,LTD (557821750)
Registrant - BONNE CO.,LTD (557821750)
Establishment
NameAddressID/FEIBusiness Operations
HANACOS CO., LTD.690177857manufacture(69997-120)

Revised: 7/2018
 
BONNE CO.,LTD