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

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.

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DECIEM The Ordinary Mineral UV Filters SPF30 with Antioxidants

Acrtive Ingredients

Zinc Oxide (14.03%)

Titanium Dioxide  (5.44%)

Purpose

UV Filter

Uses

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

Other Information

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.

Principle Display Panel

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)

Revised: 9/2021
Document Id: cd29770b-4cba-4171-e053-2995a90ae25a
Set id: cd2978ac-1af9-5226-e053-2995a90a0aae
Version: 1
Effective Time: 20210929
 
Deciem Inc