THE ORDINARY SUNCARE MINERAL UV FILTERS WITH ANTIOXIDANTS SPF15- zinc oxide, titanium dioxide lotion

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 Deciem Inc, Northwest Cosmetic Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Acrtive Ingredients

Zinc Oxide (9.76%)

Titanium Dioxide (3.74%)

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

INGREDIENTS AND APPEARANCE

THE ORDINARY SUNCARE MINERAL UV FILTERS WITH ANTIOXIDANTS   SPF15
zinc oxide, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72208-353
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
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72208-353-02	1 in 1 CARTON	05/18/2018
1	NDC: 72208-353-01	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 - Deciem Inc (203133665)

Establishment
Name	Address	ID/FEI	Business Operations
Crystal Claire Cosmetics Inc.		205493484	manufacture(72208-353) , pack(72208-353)

Establishment
Name	Address	ID/FEI	Business Operations
Northwest Cosmetic Labs		929572014	manufacture(72208-353) , pack(72208-353)