Label: LAGOM CELLUS SUN GEL- octinoxate, octocrylene, octisalate gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated January 8, 2018

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  • ACTIVE INGREDIENT

    OCTINOXATE 7.00%

    OCTOCRYLENE 5.00%

    OCTISALATE 4.00%

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    Helps prevent sunburn

  • DOSAGE & ADMINISTRATION

    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

  • 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 using and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

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

  • INACTIVE INGREDIENT

    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

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    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)
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