UGLY DUCK MIRACLE MULTI SHIELD SUN GEL- octinoxate, octisalate, titanium dioxide, gel

Ugly Duck Miracle Multi Shield Sun Gel by

Drug Labeling and Warnings

Ugly Duck Miracle Multi Shield Sun Gel by is a Otc medication manufactured, distributed, or labeled by EREPH CO., LTD, EYESOME. Co.,Ltd. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Ethylhexyl Methoxycinnamate (Octinoxate) (7%)

Ethylhexyl Salicylate (Octisalate)(3%)

Titanium Dioxide (1.494%)

Purpose

Sunscreen

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Warnings

For external use only
Do not use when skin is red, inflamed, irritated, or painful
When using this product
- do not apply on other parts of the body
- do not use on damaged or broken skin
- avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
- do not apply directly to wound or open cut
Stop use and ask a doctor if
- Rash or irritation on skin develops and lasts

Uses

Helps prevent sunburn

Directions

Apply liberally 15 minutes before sun exposure.
Reapply at least every 2 hours.
Use a water-resistant sunscreen if swimming or sweating.
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
 Limit time in the sun, especially from 10 a.m. - 2 p.m.
 Wear long-sleeved shirts, pants, hats, and sunglasses.
Children under 6 months of age: ask a doctor

Inactive Ingredients

Water, Homosalate, Pentylene Glycol, Methylpropanediol, Caprylyl Methicone, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Isononyl Isononanoate, Ethylhexyl Triazone, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, Cyclopentasiloxane, Phenoxyethanol, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Aluminum Hydroxide, Stearic Acid, Dimethicone/Vinyl Dimethicone Crosspolymer, Tocopheryl Acetate, Sorbitan Isostearate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Allantoin, Polysorbate 80, Butylene Glycol, Sorbitan Oleate, BHT, Xanthan Gum, Biosaccharide Gum-4, Sodium Hyaluronate, Moringa Oleifera Seed Oil, Ethylhexylglycerin, Camellia Sinensis Leaf Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract,

Ugly Duck Miracle Multi Shield Sun Gel

INGREDIENTS AND APPEARANCE

UGLY DUCK MIRACLE MULTI SHIELD SUN GEL 
octinoxate, octisalate, titanium dioxide, gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71624-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	4.2 g  in 60 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	1.8 g  in 60 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	0.8964 g  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
Homosalate (UNII: V06SV4M95S)
Pentylene Glycol (UNII: 50C1307PZG)
Methylpropanediol (UNII: N8F53B3R4R)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
BEMOTRIZINOL (UNII: PWZ1720CBH)
Isononyl Isononanoate (UNII: S4V5BS6GCX)
Ethylhexyl Triazone (UNII: XQN8R9SAK4)
LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EX0F4CZ66H)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
Phenoxyethanol (UNII: HIE492ZZ3T)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
Isohexadecane (UNII: 918X1OUF1E)
Aluminum Hydroxide (UNII: 5QB0T2IUN0)
Stearic Acid (UNII: 4ELV7Z65AP)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
Allantoin (UNII: 344S277G0Z)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Butylene Glycol (UNII: 3XUS85K0RA)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
TRIS-BHT MESITYLENE (UNII: 51DM34B894)
Xanthan Gum (UNII: TTV12P4NEE)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)
Ethylhexylglycerin (UNII: 147D247K3P)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CRANBERRY (UNII: 0MVO31Q3QS)
Blackberry (UNII: 8A6OMU3I8L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71624-100-02	1 in 1 PACKAGE	07/26/2017
1	NDC: 71624-100-01	60 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	07/26/2017

Labeler - EREPH CO., LTD (690038933)

Registrant - EREPH CO., LTD (690038933)

Establishment
Name	Address	ID/FEI	Business Operations
EREPH CO., LTD		690038933	relabel(71624-100)

Establishment
Name	Address	ID/FEI	Business Operations
EYESOME. Co.,Ltd.		557795360	manufacture(71624-100)