Label: MIELLE ILLUMINATING FACE- sunscreen cream

  • 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 March 12, 2021

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  • ACTIVE INGREDIENT

    active ingredients

  • PRINCIPAL DISPLAY PANEL

    package label principal

  • INGREDIENTS AND APPEARANCE
    MIELLE ILLUMINATING FACE 
    sunscreen cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60717-720
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.05 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.025 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
    BAMBUSA VULGARIS LEAF (UNII: EMY54R518C)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
    PEA PROTEIN (UNII: 7Q50F46595)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)  
    CURDLAN (UNII: 6930DL209R)  
    ACETYL TYROSYLARGININE CETYL ESTER (UNII: 3M7W78X5IR)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYETHYLENE GLYCOL 4500 (UNII: TVH7653921)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    POLYISOBUTYLENE (1100000 MW) (UNII: FLT10CH37X)  
    SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
    HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V)  
    SODIUM ACRYLATE (UNII: 7C98FKB43H)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60717-720-571 in 1 TUBE; Type 0: Not a Combination Product03/12/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/12/2021
    Labeler - RNA PHARMA, LLC (079103999)
    Establishment
    NameAddressID/FEIBusiness Operations
    RNA PHARMA, LLC079103999manufacture(60717-720)