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

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.

OrdinarySPF15

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	05/18/2018	07/31/2021

Labeler - Deciem Inc (203133665)

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

Revised: 6/2021

Document Id: 2b29c6c3-382b-47f7-b2d9-be89e4d4a50c

Set id: 3aefc813-ee82-4eea-9a7a-f7300d5c6ec7

Version: 7

Effective Time: 20210629

Deciem Inc