Label: UGLY DUCK MIRACLE MULTI SHIELD SUN GEL- octinoxate, octisalate, titanium dioxide, gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 71624-100-01, 71624-100-02 - Packager: EREPH CO., LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated July 26, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Keep out of reach of children
-
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
-
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, gelProduct 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)
