Label: SUN BLOCK- octyl methoxycinnamate benzophenone-3 titanium dioxide homosalate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51414-200-01, 51414-200-02, 51414-200-03, 51414-200-04, view more51414-200-05, 51414-200-06, 51414-200-07, 51414-200-08, 51414-200-09, 51414-200-10, 51414-200-11, 51414-200-12, 51414-200-13, 51414-200-14, 51414-200-15 - Packager: Yuyao Jessie Promotional Products Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 7, 2010
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- Active Ingredient
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- Warnings
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- Inactive Ingredient
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUN BLOCK
octyl methoxycinnamate benzophenone-3 titanium dioxide homosalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51414-200 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 8 mL in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 7.5 mL in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 8 mL in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 6 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51414-200-01 15 mL in 1 BOTTLE 2 NDC:51414-200-02 20 mL in 1 BOTTLE 3 NDC:51414-200-03 30 mL in 1 BOTTLE 4 NDC:51414-200-04 40 mL in 1 BOTTLE 5 NDC:51414-200-05 50 mL in 1 BOTTLE 6 NDC:51414-200-06 60 mL in 1 BOTTLE 7 NDC:51414-200-07 70 mL in 1 BOTTLE 8 NDC:51414-200-08 80 mL in 1 BOTTLE 9 NDC:51414-200-09 90 mL in 1 BOTTLE 10 NDC:51414-200-10 100 mL in 1 BOTTLE 11 NDC:51414-200-11 200 mL in 1 BOTTLE 12 NDC:51414-200-12 250 mL in 1 BOTTLE 13 NDC:51414-200-13 300 mL in 1 BOTTLE 14 NDC:51414-200-14 400 mL in 1 BOTTLE 15 NDC:51414-200-15 500 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/30/2010 Labeler - Yuyao Jessie Promotional Products Co., Ltd. (529892305) Establishment Name Address ID/FEI Business Operations Yuyao Jessie Promotional Products Co., Ltd. 529892305 manufacture
