LAGOM CELLUS SUN GEL- octinoxate, octocrylene, octisalate gel 
SKINMED International 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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Drug Facts

OCTINOXATE 7.00%

OCTOCRYLENE 5.00%

OCTISALATE 4.00%

Sunscreen

Helps prevent sunburn

Apply liberally 15 minutes before sun exposure. Reapply at least every two hours

Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses

Ask a doctor to use for children under 6 months

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 using and ask a doctor if rash occurs.

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Water
Alcohol Denat.
Propanediol
Butyl Methoxydibenzoylmethane
Methyl Methacrylate Crosspolymer
Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine
Methoxy PEG/PPG-25/4 Dimethicone
Bis-PEG/PPG-20/5 PEG/PPG-20/5 Dimethicone
Caprylic/Capric Triglyceride
Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer
Dimethicone
Isohexadecane
Acrylates/C10-30 Alkyl Acrylate Crosspolymer
Caprylyl Glycol
Citrus Aurantium Dulcis (Orange) Oil
Ethylhexylglycerin
Polysorbate 80
1,2-Hexanediol
BHT
Sodium Hydroxide
Lavandula Angustifolia (Lavender) Oil
Sorbitan Oleate
Disodium EDTA
Geranium Maculatum Oil
Citrus Aurantium Bergamia (Bergamot) Fruit Oil
Santalum Album (Sandalwood) Oil
Rose Flower Oil
Chamomilla Recutita (Matricaria) Flower Oil
Urea
Yeast Amino Acids
Trehalose
Betaine
Taurine
Inositol
Styrax Benzoin Gum
Commiphora Myrrha Oil
Phenoxyethanol
Potassium sorbate

image description

LAGOM CELLUS SUN GEL 
octinoxate, octocrylene, octisalate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70738-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.5 mg  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.5 mg  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
PROPANEDIOL (UNII: 5965N8W85T)  
AVOBENZONE (UNII: G63QQF2NOX)  
BEMOTRIZINOL (UNII: PWZ1720CBH)  
BIS-PEG/PPG-16/16 PEG/PPG-16/16 DIMETHICONE (UNII: 55A74AJ3KB)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ORANGE OIL (UNII: AKN3KSD11B)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GERANIUM MACULATUM ROOT OIL (UNII: H2E371EDYX)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
SANDALWOOD OIL (UNII: X7X01WMQ5F)  
ROSA RUGOSA FLOWER BUD (UNII: TZ0BE8I3MW)  
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
UREA (UNII: 8W8T17847W)  
TREHALOSE (UNII: B8WCK70T7I)  
BETAINE (UNII: 3SCV180C9W)  
TAURINE (UNII: 1EQV5MLY3D)  
INOSITOL (UNII: 4L6452S749)  
STYRAX BENZOIN RESIN (UNII: FE663Z8IRO)  
MYRRH OIL (UNII: H74221J5J4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70738-001-021 in 1 PACKAGE01/08/2018
1NDC:70738-001-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/08/2018
Labeler - SKINMED International Co., Ltd. (689846920)
Registrant - SKINMED International Co., Ltd. (689846920)
Establishment
NameAddressID/FEIBusiness Operations
Cosmecca Korea Co., Ltd.688830827manufacture(70738-001)

Revised: 1/2018
Document Id: f4f07fd9-66f9-400a-bd67-9655cf28952a
Set id: c63f0408-ed99-4e31-9a75-1044af9874f3
Version: 3
Effective Time: 20180108
 
SKINMED International Co., Ltd.