UGLY DUCK MIRACLE MULTI SHIELD SUN GEL- octinoxate, octisalate, titanium dioxide, gel 
EREPH CO., LTD

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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Ugly Duck Miracle Multi Shield Sun Gel

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

sun gel

UGLY DUCK MIRACLE MULTI SHIELD SUN GEL 
octinoxate, octisalate, titanium dioxide, gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71624-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate4.2 g  in 60 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate1.8 g  in 60 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.8964 g  in 60 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71624-100-021 in 1 PACKAGE07/26/2017
1NDC:71624-100-0160 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/26/2017
Labeler - EREPH CO., LTD (690038933)
Registrant - EREPH CO., LTD (690038933)
Establishment
NameAddressID/FEIBusiness Operations
EREPH CO., LTD690038933relabel(71624-100)
Establishment
NameAddressID/FEIBusiness Operations
EYESOME. Co.,Ltd. 557795360manufacture(71624-100)

Revised: 7/2017
Document Id: eca27d6d-39b7-4088-a969-e5696058f5e9
Set id: fd26f2dd-26d6-42d5-80df-b4ef42c64925
Version: 1
Effective Time: 20170726
 
EREPH CO., LTD