Label: CT SPF 20- avobenzone lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 November 23, 2020

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  • ACTIVE INGREDIENT

    Avobenzone 3%

    Homosalate 10%

    Octisalte 5%

    Octocrylene 10%

  • PURPOSE

    Sunscreen

    Sunscreen

    Sunscreen

    Sunscreen

  • INDICATIONS & USAGE

    helps prevent sunburn

    if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

  • 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

    Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    apply liberally and evenly 15 minutes before sun exposure

    children under 6 months of age: ask a doctor

    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 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

    *use a water-resistant sunscreen if swimming or sweating

    *reapply at least every 2 hours

  • OTHER SAFETY INFORMATION

    protect teh product in this container from excessive heat and direct sun

  • INACTIVE INGREDIENT

    Water, C12-15 Alkyl Benzoate Butylene Glycol, Coconut Alkanes, Glycerin, Silica, Crambe Abyssinica Seed Oil, Cetyl Alcohol, Glyceryl Stearate, Caprylyl Methicone, Potassium Cetyl Phosphate, PEG-75 Stearate, Dimethyl Isosorbide, Polysorbate 20, Phenoxyethanol, Hydroxyacetophenone, Marrubium Vulgare Extract, Ceteth-20, Steareth-20, Coco-Caprylate/Caprate, Xanthan Gum, Carbomer, Disodium EDTA, Rose (Rosa Damascera) Extract, Ethylhexylglycerin, Sodium Hydroxide, Beta-Carotene, Tocopherol, Xanthophylls, Michelia Alba Leaf Oil, Citric Acid, Sunflower (Helianthus Annuus) Seed Oil, Rosemary (Rosmarinus Officinalis) Leaf Extract, Potato (Solanum Tuberosum) Pulp Extract, Acetyl Tetrapeptide-11, Acetyl Tetrapeptide-9, Linalool, Citronellol, Geraniol

  • PRINCIPAL DISPLAY PANEL

    50mL Carton Artwork

  • INGREDIENTS AND APPEARANCE
    CT SPF 20 
    avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51280-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ROSEMARY (UNII: IJ67X351P9)  
    WATER (UNII: 059QF0KO0R)  
    HOREHOUND (UNII: K08036XEJV)  
    .BETA.-CAROTENE (UNII: 01YAE03M7J)  
    LUTEIN (UNII: X72A60C9MT)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ACETYL TETRAPEPTIDE-11 (UNII: 0R3VC3BV8I)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL STEARATE/PEG-75 STEARATE (UNII: 6PSS3TQ3UY)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    POTATO PEEL (UNII: MW2PWY5TYZ)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)  
    MICHELIA ALBA LEAF OIL (UNII: 002RK9L1FN)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CARBOMER 934 (UNII: Z135WT9208)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETETH-20 (UNII: I835H2IHHX)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ACETYL TETRAPEPTIDE-9 (UNII: VMO8OOD3V0)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51280-005-511 in 1 CARTON11/23/2020
    150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:51280-005-211 in 1 CARTON11/23/2020
    215 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/23/2020
    Labeler - Meiyume (225596238)
    Registrant - Lornamead (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Meiyume225596238pack(51280-005) , manufacture(51280-005)
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