Label: EVERYDAY FACIAL MOISTURIZER AND SUNSCREEN SPF 20- zinc oxide cream

  • 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 February 20, 2023

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT: Zinc Oxide 16.32%

  • Purpose

    Sunscreen

  • INDICATIONS & USAGE

    USE: Provides broad spectrum protection against UVA (cause of cancer and aging) and UVB (sunburn) rays. Recommended for all skin types. Its powerful anti-inflammatory and antioxident properties (green tea, algae, and Vitamin E) guard against free radical damage. No ghostly residue. PABA free. Oil free.

  • WARNING:

    For external us only. Do not get into eyes.

  • STOP USE

    Discontinue use if irritation or rash appears.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Apply daily before sun exposure Re-apply after swimming.

  • OTHER INGREDIENTS:

    Water, Cyclopentasiloxane, PEG-10 Dimethicone, Dimethicone, Butylene Glycol, Caprylyl Methicone, Isononyl Isononanoate, Dipropylene Glycol, Sodium Chloride, Hydrogenated Polyisobutene, Disteardimonium Hectorite, Dimethiconol, Sodium Hyaluronate, Sodium PCA, Algae Extract, Camellia Sinensis Leaf Extract, Dipotassium Glycyrrhizate, Panthenol, Tocopheryl Acetate, Methicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Cetyl PEG/PPG-10/1 Dimethicone, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Fragrance.

  • DESCRIPTION

    Ottilie and Lulu Non-Chemical Sunscreen Smooth Silky Feel Water-Resistant - Dermatologist Tested Allergy Tested - Clinically Tested Not Tested on Animals - Made in the USA Please Visit us at www.ottilieandlulu.com Manufactured exclusively for 714 Essentials LTD. Dba: Ottilie and Lulu'" NY. NY 10024

  • PRINCIPAL DISPLAY PANEL

    Ottilie and Lulu Everyday Facial Moisturizer And Sunscreen SPF 20  Clean, Clear, Healthy Skin For Tweens  2.5 fl oz / 75 ml

  • PRINCIPAL DISPLAY PANEL

    Please Visit us at  www.ottilieandlulu.com  Manufactured exclusively
    for 714 Essentials LTD. Dba: Ottilie and Lulu'" NY. NY 10024  2.5 fl oz / 75 ml  8  99837 00209  3

  • PRINCIPAL DISPLAY PANEL

    Ottilie Lulu1

  • PRINCIPAL DISPLAY PANEL

    Ottilie Lulu2

  • INGREDIENTS AND APPEARANCE
    EVERYDAY FACIAL MOISTURIZER AND SUNSCREEN SPF 20 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76230-727
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE163.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76230-727-091 in 1 PACKAGE12/19/2017
    175 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/09/2011
    Labeler - 714 Essentials LTD (829052146)
    Establishment
    NameAddressID/FEIBusiness Operations
    Englewood Lab, Inc.172198223manufacture(76230-727)