Label: THE ORDINARY SUNCARE MINERAL UV FILTERS WITH ANTIOXIDANTS SPF30- zinc oxide, titanium dioxid lotion

  • 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 September 29, 2021

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

  • Acrtive Ingredients

    Zinc Oxide (14.03%)

    Titanium Dioxide  (5.44%)

    Purpose

    UV Filter

  • Uses

    • helps prevent sunburn
    • SPF 30
  • Warnings

    ​Skin Cancer/Skin Aging Alert; ​Spending time in the sun increases your risk of skin cancer and early skin aging.  This product has been shown only to help prevent sunburn,  ​not​ skin cancer or early skin aging.

    ​Do not use on damaged or broked skin.

    ​When using this product keep out of eyes.  Rinse with water to remove.

    Stop use and ask a doctor if rash occurs

    ​For external use only.

  • Directions

    •   apply liverally and evenly to face 15 minutes before sun exposue
    •   for children under 6 months of age: Ask a doctor prior to use.
    • ​Reapply
    • Reapply at lease every 2 hours
    • use a water resistant sunscreen if swimming or sweating 
  • Other Information

    • Protect the product in this container from excessive heat and direct sun
    • ​Shake well ​before using
  • Inactive Ingredients

    Water, Cyclopentasiloxane, PEG-10 Dimethicone, Glycerin, Helianthus Annuus Seed Oil, PEG-9 Polydimethylsiloxyethyl Dimethicone, Hexyl Laurate, Polyglyceryl-4 Isostearate, Caprylic/Capric Triglyceride, Dimethicone/PEG-10/15 Crosspolymer, Astaxanthin, Disodium Uridine Phosphate, Ethyl Ferulate, Rosmarinus Officinalis Leaf Extract, Tasmannia Lanceolata Fruit/Leaf Extract, Haematococcus Pluvialis Extract, Picea Mariana Bark Extract, Arginine, Aspartic Acid, Glycine, Alanine, Serine, Valine, Isoleucine, Proline, Threonine, Histidine, Phenylalanine, Sodium PCA, PCA, Sodium Lactate, Glucose, Maltose, Fructose, Trehalose, Urea, Allantoin, Sodium Hyaluronate, Linoleic Acid, Oleic Acid, Phytosteryl Canola Glycerides, Palmitic Acid, Stearic Acid, Isochrysis Galbana Extract, Lysolecithin, Lecithin, Triolein, Pentylene Glycol, Dipropylene Glycol, Polyglyceryl-10 Oleate, Polyglyceryl-5 Trioleate, Polyglyceryl-10 Stearate, Tocopherol, Alumina, Citric Acid, Trisodium Ethylenediamine Disuccinate, Sodium Chloride, Sodium Hydroxide, Phenoxyethanol, Chlorphenesin.

  • PRINCIPAL DISPLAY PANEL

    Principle Display Panel

  • INGREDIENTS AND APPEARANCE
    THE ORDINARY SUNCARE MINERAL UV FILTERS WITH ANTIOXIDANTS  SPF30
    zinc oxide, titanium dioxid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72208-352
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION14.03 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.44 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ASTAXANTHIN (UNII: 8XPW32PR7I)  
    URIDINE MONOPHOSPHATE DISODIUM (UNII: KD8E20071T)  
    ETHYL FERULATE (UNII: 5B8915UELW)  
    ROSEMARY (UNII: IJ67X351P9)  
    TASMANNIA LANCEOLATA WHOLE (UNII: RQ58K8571Z)  
    HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)  
    PICEA MARIANA WHOLE (UNII: U37W7O088B)  
    ARGININE (UNII: 94ZLA3W45F)  
    ASPARTIC ACID (UNII: 30KYC7MIAI)  
    GLYCINE (UNII: TE7660XO1C)  
    ALANINE (UNII: OF5P57N2ZX)  
    SERINE (UNII: 452VLY9402)  
    VALINE (UNII: HG18B9YRS7)  
    ISOLEUCINE (UNII: 04Y7590D77)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    THREONINE (UNII: 2ZD004190S)  
    HISTIDINE (UNII: 4QD397987E)  
    PHENYLALANINE (UNII: 47E5O17Y3R)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    PIDOLIC ACID (UNII: SZB83O1W42)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    MALTOSE (UNII: XJ6S9RV06F)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    TREHALOSE (UNII: B8WCK70T7I)  
    UREA (UNII: 8W8T17847W)  
    ALLANTOIN (UNII: 344S277G0Z)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    CANOLA OIL (UNII: 331KBJ17RK)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    GLYCERYL TRIOLEATE (UNII: O05EC62663)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    POLYGLYCERYL-10 OLEATE (UNII: 55C81W76DH)  
    POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72208-352-041 in 1 CARTON05/18/2018
    1NDC:72208-352-0150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/18/2018
    Labeler - Deciem Inc (203133665)
    Establishment
    NameAddressID/FEIBusiness Operations
    Crystal Claire Cosmetics Inc.205493484manufacture(72208-352) , pack(72208-352)