Label: MOISTURIZING LIP BALMSPF30- avobenzone, homosalate, octisalate, octocrylene, oxybenzone stick

  • 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 February 13, 2014

If you are a consumer or patient please visit this version.

  • Active ingredients

    Avobenzone 2.5%

    Homosalate 8.0%

    Octisalate 5.0%       

    Octocrylene 2.20%

    Oxybenzone 3.0%

  • Purpose

    Sunscreen

  • Uses

    ■Lip moisturizer: helps prevent sunburn.

  • Warnings

    For external use only

    When using this product keep out of eyes.

    Rinse with water to remove - do not use on broken skin.

    Keep out of reach of children.

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

  • Directions

    ■Apply liberally and evenly 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 value of 15

    or higher and other sun protection measures including:

    • limit time in the sun, especially from 10 AM – 2 PM

    • wear long sleeve shirts, pants, hats, and sunglasses

  • Inactive ingredients

    Beeswax, Persea Gratissima

    (Avocado) Oil, Butyrospermum Parkii (Shea)

    Butter, Hydrogenated Vegetable Oil, Acacia

    Decurrens/Jojoba/Sunflower Seed Wax Polyglyceryl-3

    Esters, Menthyl Lactate, Argania Spinosa Kernel

    Oil, Tocopheryl Acetate, Dimethicone, Helianthus

    Annuus (Sunflower) Seed Oil Unsaponifiables, Aloe

    Barbadensis Flower Extract, Bisabolol, Curcuma

    Longa (Turmeric) Root Extract, Lawsonia Inermis

    (Henna) Flower/Fruit/Leaf Extract, Melia Azadirachta

    Flower Extract, Melia Azadirachta Leaf Extract,

    Ocimum Basilicum (Basil) Flower/Leaf Extract,

    Ocimum Sanctum Leaf Extract, Coccinia Indica

    Fruit Extract, Corallina Officinalis Extract, Amino

    Esters-1, Citrus Aurantium Dulcis (Orange) Peel Oil,

    Simmondsia Chinensis (Jojoba) Seed Oil, Retinyl

    Palmitate, Palmitoyl Oligopeptide, Ethylhexyl

    Palmitate, Tribehenin, Sorbitan Isostearate, Menthol,

    Caprylyl Glycol, Phenoxyethanol, Chlorphenesin.

  • Other information

    ■Protect from excessive heat and direct sun.

  • Questions or comments visit:

    www.arthurglosmandentalbeauty.com

    Or call 1.855.333.2544

  • MOISTURIZING LIP BALM SUNSCREEN BROAD SPECTRUM SPF-30 (62111-0211-3)

    advanced dental health - beauty

    ARTHUR GLOSMAN DDS

            Beverly Hills

    MOISTURIZING

    LIP BALM

    SUNSCREEN

    BROAD

    SPECTRUM

    SPF-30

    Net Wt. 0.15 oz. / 4.3 g

    Distributed by:

    AKG Innovations, LLC

    450 N. Roxbury Drive,

    Suite 222,

    Beverly Hills, CA

    90210

    Made in USA

    #90213

    MOISTURIZING

    LIP BALM

    SPF-30

    BROAD SPECTRUM

    SUNSCREEN

    Ice blue stick glides on smoothly,

    leaving a soft sheen on the lips.

    Cools with Menthol; moisturizes

    with Avocado Oil, Shea Butter and

    Jojoba Seed Oil; calms and soothes

    with Dimethicone. UVA/UVB

    SPF 30 protection to help prevent

    sunburned lips. Can be used as

    often as necessary on the lips and

    around the lip area.

    LipBalmSPF30

  • INGREDIENTS AND APPEARANCE
    MOISTURIZING LIP BALMSPF30 
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62111-0211
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE25 mg  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE80 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE22.0 mg  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE30 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ALOE VERA FLOWER (UNII: 575DY8C1ER)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CURCUMA LONGA LEAF (UNII: H2HC4RY52C)  
    LAWSONIA INERMIS FLOWERING TOP (UNII: UF2093XE64)  
    AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM)  
    AZADIRACHTA INDICA LEAF (UNII: HKY915780T)  
    OCIMUM BASILICUM FLOWERING TOP (UNII: 7SAB275FP2)  
    OCIMUM TENUIFLORUM TOP (UNII: 34T63W8ULS)  
    COCCINIA GRANDIS FRUIT (UNII: VLJ6WOT3K5)  
    CORALLINA OFFICINALIS (UNII: 4004498D06)  
    CITRUS SINENSIS FLOWER OIL (UNII: AJ56JP5TFP)  
    JOJOBA OIL (UNII: 724GKU717M)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    Sorbitan Isostearate (UNII: 01S2G2C1E4)  
    MENTHOL (UNII: L7T10EIP3A)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62111-0211-31 in 1 BOX
    14.3 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/06/2014
    Labeler - AKG Innovations LLC (056576137)
    Establishment
    NameAddressID/FEIBusiness Operations
    Englewood Labs LLC 172198223manufacture(62111-0211)