THE PURE LOTUS JEJU BOTANICAL SUNCREAM- homosalate, octocrylene cream 
THE LOTUS 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.

----------

82235-302 THE PURE LOTUS Jeju Botanical Sun Cream

Active ingredients

Homosalaste(10%)

Octocrylene(3%)

Purpose

Sunscreen

Uses

  • helps prevent sunburn and decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only

Stop use and ask doctor if

  • Condition worsens
  • symptoms last more than 7days or clear up and occur again within a few days

Do not use

  • Do not apply to wounds or damaged skin
  • In case of abnormal symptoms or side effects of red spots, swelling, or itching
  • Do not get into eyes.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Direction

For Sunscreen use;

  • Apply to your skin evenly and put on 3~4times per day

Other Information

  • Store at room temperature away from direct sunlight.

Inactive ingredients

Water, Aloe Barbadensis Leaf Extract, Camellia Sinensis Leaf Extract, Butylene Glycol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Niacinamide, 1,2-Hexanediol, Nelumbo Nucifera Leaf Extract, Glyceryl Stearate, C14-22 Alcohols, Oryza Sativa (Rice) Extract, Cetearyl Olivate, Arachidyl Alcohol, Citrus Unshiu Peel Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Nelumbo Nucifera Root Extract, Tromethamine, VP/Eicosene Copolymer, Sorbitan Olivate, Opuntia Coccinellifera Fruit Extract, Behenyl Alcohol, Sodium Stearoyl Glutamate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylhexylglycerin, Caprylyl Glycol, Citrus Limon (Lemon) Peel Oil, C12-20 Alkyl Glucoside, Carbomer, Arachidyl Glucoside, Mallotus Japonicus Bark Extract, Xanthan Gum, Adenosine, Lavandula Angustifolia (Lavender) Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Glucose, Citrus Aurantifolia (Lime) Oil, Juniperus Mexicana Oil, Pelargonium Graveolens Flower Oil, Eucalyptus Globulus Leaf Oil, Chamomilla Recutita (Matricaria) Flower Oil, Limonene, Linalool, Citral.

Package Label

82235-301

THE PURE LOTUS JEJU BOTANICAL SUNCREAM 
homosalate, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82235-302
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LEMON OIL (UNII: I9GRO824LL)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
CITRAL (UNII: T7EU0O9VPP)  
LIME OIL (UNII: UZH29XGA8G)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ADENOSINE (UNII: K72T3FS567)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
NELUMBO NUCIFERA LEAF (UNII: 60C608DPVT)  
RICE GERM (UNII: 7N2B70SFEZ)  
ROSEMARY (UNII: IJ67X351P9)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)  
BEMOTRIZINOL (UNII: PWZ1720CBH)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
NIACINAMIDE (UNII: 25X51I8RD4)  
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
MALLOTUS JAPONICUS BARK (UNII: 4PG720HL9T)  
TANGERINE PEEL (UNII: JU3D414057)  
WATER (UNII: 059QF0KO0R)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
NELUMBO NUCIFERA ROOT (UNII: F60P1G6K6N)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TROMETHAMINE (UNII: 023C2WHX2V)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
C14-22 ALCOHOLS (UNII: B1K89384RJ)  
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
DOCOSANOL (UNII: 9G1OE216XY)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
JUNIPERUS DEPPEANA WOOD OIL (UNII: 4739QA5686)  
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82235-302-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product09/15/202109/23/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/15/202109/23/2021
Labeler - THE LOTUS Co.,Ltd. (694858590)
Registrant - THE LOTUS Co.,Ltd. (694858590)
Establishment
NameAddressID/FEIBusiness Operations
THE LOTUS Co.,Ltd.694858590manufacture(82235-302)

Revised: 9/2021
 
THE LOTUS Co.,Ltd.