DECIEM The Ordinary Mineral UV Filters with Antioxidants

THE ORDINARY SUNCARE MINERAL UV FILTERS WITH ANTIOXIDANTS by

Drug Labeling and Warnings

THE ORDINARY SUNCARE MINERAL UV FILTERS WITH ANTIOXIDANTS by is a Otc medication manufactured, distributed, or labeled by Crystal Claire Cosmetics Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

THE ORDINARY SUNCARE MINERAL UV FILTERS WITH ANTIOXIDANTS- zinc oxide, titanium dioxide lotion 
Crystal Claire Cosmetics 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 with Antioxidants

THE ORDINARY SUNCARE MINERAL UV FILTERS WITH ANTIOXIDANTS 
zinc oxide, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12120-353
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	9.76 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.74 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PICEA MARIANA WHOLE (UNII: U37W7O088B)
THREONINE (UNII: 2ZD004190S)
PHENYLALANINE (UNII: 47E5O17Y3R)
MALTOSE (UNII: XJ6S9RV06F)
CHLORPHENESIN (UNII: I670DAL4SZ)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ASTAXANTHIN (UNII: 8XPW32PR7I)
ARGININE (UNII: 94ZLA3W45F)
GLYCINE (UNII: TE7660XO1C)
SERINE (UNII: 452VLY9402)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
ASPARTIC ACID (UNII: 30KYC7MIAI)
VALINE (UNII: HG18B9YRS7)
ISOLEUCINE (UNII: 04Y7590D77)
PROLINE (UNII: 9DLQ4CIU6V)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
SODIUM LACTATE (UNII: TU7HW0W0QT)
FRUCTOSE (UNII: 6YSS42VSEV)
OLEIC ACID (UNII: 2UMI9U37CP)
STEARIC ACID (UNII: 4ELV7Z65AP)
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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
CANOLA OIL (UNII: 331KBJ17RK)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
URIDINE MONOPHOSPHATE DISODIUM (UNII: KD8E20071T)
ETHYL FERULATE (UNII: 5B8915UELW)
ROSEMARY (UNII: IJ67X351P9)
TASMANNIA LANCEOLATA WHOLE (UNII: RQ58K8571Z)
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)
ALANINE (UNII: OF5P57N2ZX)
HISTIDINE (UNII: 4QD397987E)
PIDOLIC ACID (UNII: SZB83O1W42)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
TREHALOSE (UNII: B8WCK70T7I)
UREA (UNII: 8W8T17847W)
ALLANTOIN (UNII: 344S277G0Z)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PALMITIC ACID (UNII: 2V16EO95H1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12120-353-02	1 in 1 CARTON	05/18/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/18/2018

Labeler - Crystal Claire Cosmetics Inc. (205493484)

Establishment
Name	Address	ID/FEI	Business Operations
Crystal Claire Cosmetics Inc.		205493484	manufacture(12120-353) , pack(12120-353) , analysis(12120-353) , relabel(12120-353) , repack(12120-353)

Revised: 12/2020

Document Id: b13f4f29-5fa2-7903-e053-2995a90a5a70

34390-5

Set id: b13f3eaa-3435-db36-e053-2a95a90a7845

Version: 1

Effective Time: 20201229