Label: SOORYEHAN JADAN SUN MILD- octocrylene, zinc oxide, octinoxate, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 53208-446-01, 53208-446-02 - Packager: LG Household and Healthcare, Inc.
- 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 May 20, 2010
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- ACTIVE INGREDIENT
- WARNINGS AND PRECAUTIONS
- KEEP OUT OF REACH OF CHILDREN
- WHEN USING
- STOP USE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SOORYEHAN JADAN SUN MILD
octocrylene, zinc oxide, octinoxate, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53208-446 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 5.612 mL in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7 mL in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2 mL in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2 in 100 mL Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HEXYL LAURATE (UNII: 4CG9F9W01Q) GLYCERIN (UNII: PDC6A3C0OX) ISOSTEARIC ACID (UNII: X33R8U0062) PANTHENOL (UNII: WV9CM0O67Z) SODIUM CHLORIDE (UNII: 451W47IQ8X) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) ETHYLPARABEN (UNII: 14255EXE39) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53208-446-02 1 in 1 BOX 1 NDC:53208-446-01 100 mL in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part358 05/20/2010 Labeler - LG Household and Healthcare, Inc. (688276187) Registrant - LG Household and Healthcare, Inc. (688276187) Establishment Name Address ID/FEI Business Operations LG Household and Healthcare, Inc. 688276187 manufacture