LYCORIS RUBUS BRIGHTENING BB SPF40 PA PLUS PLUS- octinoxate, titanium dioxide, zinc oxide cream 
Lycoris 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 7.5%, Titanium dioxide 5%, Zinc oxide 5%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Cyclopentasiloxane, Butylene glycol, Isoamyl p-methoxycinnamate, Cetyl PEG/PPG-10/1 Dimethicone, Betaine, Cetyl ethylhexanoate, Polysorbate 60, Dimethicone, Sodium chloride, Sodium hyaluronate, PEG-40 stearate, Iron oxides, Bentonite, Talc, Stearic acide, Phenoxyethanol, Methylparaben, Ethylparaben, Butylparaben, Propylparaben, Isobutylparaben, Tocopheryl acetate, Perfume, Rubus hirsutus fruit/leaf extract, Camellia Japonica Ovary Powder, Centella asiatica extract, Lavandula angustifolia (Lavender) extract, Glycyrrhiza glabra (Licorice) root extract, Triticum vulgare (Wheat) flour lipids, Allantoin, Lysine HCL, Disodium EDTA, Proline, Sodium ascorbyl phosphate, Linum usitatissimum (Linseed) seed extract, Hibiscus esculentus fruit extract, Aloe barbadensis leaf juice, Arctium lappa root extract, Hibiscus mutabilis flower extract, Corchorus olitorius leaf extract, Dimethyl sulfone

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: 1. In case of having following symptoms after using this, you’re advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problem such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In the case of getting it into your eyes, you have to wash it immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of babies and children

INDICATIONS AND USAGE

Indications and usage: 1. Tighten the lid after using it. 2. Don’t keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight. 3. Use it in the evening after washing face.

DOSAGE AND ADMINISTRATION

Dosage and administration: Apply after washing face. Take a small amount of cream about 1.0-1.5g on to the fingertips and gently massage over the entire face.(cheeks, nostrils, corners, forehead, and the around of eyes, even your hands) Blot face lightly with tissue, and may sleep without washing it.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

Image of carton

LYCORIS RUBUS BRIGHTENING BB  SPF40 PA PLUS PLUS
octinoxate, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60778-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3 mg  in 40 mL
Titanium dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium dioxide2 mg  in 40 mL
Zinc oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2 mg  in 40 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60778-010-0140 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/01/2013
Labeler - Lycoris Co., Ltd. (688301521)
Registrant - Lycoris Co., Ltd. (688301521)
Establishment
NameAddressID/FEIBusiness Operations
Lycoris Co., Ltd.688301521manufacture(60778-010)

Revised: 10/2013
Document Id: a81dcd31-a562-47ba-89e5-f9a5cfdcf0c1
Set id: 4d78a6bb-2d1f-4ca6-a6f5-37269eb3a4a2
Version: 1
Effective Time: 20131007
 
Lycoris Co., Ltd.