Label: TIEGE HANLEY AM MORNING FACIAL MOISTURIZER WITH SPF20- octinoxate, avobenzone, and octocrylene 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 January 9, 2020

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    EthylMethoxycinnamate 5.5%Sunscreen
    Butyl Methoxydibenzoylmethane 2.5%Sunscreen
    Octocrylene 2.0%Sunscreen
  • Uses

    Helps prevent sunburn. If used as directed with Other sun protection measures, decreases the risk of skin cancer and early skin aging cause by sun.

  • Warnings

    For External Use Only. Avoid contact with Eyes. Discontinue use if skin irritation occurs.

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

  • Directions

    After washing your face, massage a pea-sized amount into entire face and neck in a gentle (yet masculine) circular motion. For detailed usage tips, visit: www.tiege.com/tips

  • Inactive Ingredients

    Aqua, Isocecyl Neopentanoate, Cyclopentasiloxane, Bis-PEG-12 Dimethicone Beeswax, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Caprylyl Glycol, Sodium Hydroxide, HydroxypropylStarch Phosphate, C18-38 Alkyl Hydroxystearoyl Stearate, Sodium Acrylate, Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80 , Calendula Officinalis Flower Extract, Plantago Major Leaf Extract, Carbomer, Disodium EDTA, Lavandula Officinalis ( Lavender) Oil, Rosmarinus Officinalis ( Rosemary) Leaf Oil

  • PRINCIPAL DISPLAY PANEL - 22 mL Tube Label

    TIÉGE
    HANLEY

    Uncomplicated Skin Care for Men™

    AM

    Morning Facial
    Moisturizer with SPF 20

    0.75 FL. OZ. / 22mL

    PRINCIPAL DISPLAY PANEL - 22 mL Tube Label
  • INGREDIENTS AND APPEARANCE
    TIEGE HANLEY AM MORNING FACIAL MOISTURIZER WITH SPF20 
    octinoxate, avobenzone, and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71714-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51) octinoxate55 mg  in 1 mL
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone25 mg  in 1 mL
    octocrylene (UNII: 5A68WGF6WM) (octocrylene - UNII:5A68WGF6WM) octocrylene20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BIS-PEG-12 DIMETHICONE (70 MPA.S) (UNII: 2JDK5W22H4)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    TETRADECYLOCTADECYL STEARATE (UNII: VX3T5G31XA)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Glycerin (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT) (UNII: 9M44R3409A)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    Lavender Oil (UNII: ZBP1YXW0H8)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PLANTAGO MAJOR LEAF (UNII: 7DC28K241X)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71714-020-2222 mL in 1 TUBE; Type 0: Not a Combination Product09/30/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35209/30/2017
    Labeler - Tiege hanley (080305325)
    Registrant - BMC 1092, Inc. dba Solo Laboratories, Inc (078831987)
    Establishment
    NameAddressID/FEIBusiness Operations
    BMC 1092, Inc. dba Solo Laboratories, Inc078831987MANUFACTURE(71714-020) , PACK(71714-020)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!