ORDAY MILD SUNCREAM- zinc oxide, titanium dioxide cream

Orday Mild Suncream by

Drug Labeling and Warnings

Orday Mild Suncream by is a Otc medication manufactured, distributed, or labeled by Elishacoy Co., Inc, COSON Co., Ltd._Osan Plant. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 11.64%
Titanium Dioxide 3.12%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure. Reapply at least every two hours

WARNINGS

For external use only.
Do not use on damaged or broken skin.
When using this product, keep out of eyes. Rinse with water to remove.
Stop using and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

INACTIVE INGREDIENT

Water, Cyclomethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Glycerin, Calamine, Propanediol, Dibutyl Adipate, Caprylyl Methicone, 1,2-Hexanediol, Disteardimonium Hectorite, Cetyl Ethylhexanoate, Magnesium Sulfate, Hydrogen Dimethicone, Betaine, Trehalose, Aluminum Hydroxide, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Sorbitan Sesquioleate, Styrene/Acrylates Copolymer, Stearic Acid, Dipotassium Glycyrrhizate, Tranexamic Acid, Inositol, Citrus Aurantium Dulcis (Orange) Peel Oil, Pentylene Glycol, Ethylhexylglycerin, Octyldodecanol, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Lavandula Angustifolia (Lavender) Oil, Rosa Damascena Flower Water, Litsea Cubeba Fruit Oil, Echium Plantagineum Seed Oil, Pelargonium Graveolens Oil, Ocimum Basilicum (Basil) Oil, Butylene Glycol, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Methyl Methacrylate Crosspolymer, Glyceryl Stearate, Xanthan Gum, Tocopherol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ORDAY MILD SUNCREAM 
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69013-026
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	116.4 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	31.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
GLYCERIN (UNII: PDC6A3C0OX)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PROPANEDIOL (UNII: 5965N8W85T)
DIBUTYL ADIPATE (UNII: F4K100DXP3)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BETAINE (UNII: 3SCV180C9W)
TREHALOSE (UNII: B8WCK70T7I)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
TRANEXAMIC ACID (UNII: 6T84R30KC1)
INOSITOL (UNII: 4L6452S749)
ORANGE OIL (UNII: AKN3KSD11B)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
OCTYLDODECANOL (UNII: 461N1O614Y)
BERGAMOT OIL (UNII: 39W1PKE3JI)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ROSA X DAMASCENA FLOWER OIL (UNII: 18920M3T13)
LITSEA OIL (UNII: 2XIW34BN6O)
ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW)
GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)
BASIL OIL (UNII: Z129UMU8LE)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: 657L0NC5MT)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
XANTHAN GUM (UNII: TTV12P4NEE)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69013-026-02	1 in 1 CARTON	04/18/2019
1	NDC: 69013-026-01	50 mL in 1 CONTAINER; 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	04/18/2019

Labeler - Elishacoy Co., Inc (631138567)

Registrant - Elishacoy Co., Inc (631138567)

Establishment
Name	Address	ID/FEI	Business Operations
COSON Co., Ltd._Osan Plant		689847210	manufacture(69013-026)