Label: SUN BLOCK SPRARY- sun block sprary spf15 spray
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Contains inactivated NDC Code(s)
NDC Code(s): 47993-215-07 - Packager: NINGBO JIANGBEI OCEAN STAR TRADING 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 February 15, 2015
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- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUN BLOCK SPRARY
sun block sprary spf15 sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47993-215 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate 3 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6 g in 100 g Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE (UNII: NMQ347994Z) 6 g in 100 g PEG-40 CASTOR OIL (UNII: 4ERD2076EF) 1 g in 100 g DISODIUM EDTA-COPPER (UNII: 6V475AX06U) 0.03 g in 100 g CARBOMER 1342 (UNII: 809Y72KV36) 0.2 g in 100 g Propylene Glycol (UNII: 6DC9Q167V3) 8 g in 100 g SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.5 g in 100 g IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) 0.07 g in 100 g METHYLPARABEN (UNII: A2I8C7HI9T) 0.15 g in 100 g WATER (UNII: 059QF0KO0R) 75.05 g in 100 g Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47993-215-07 100 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/20/2015 Labeler - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491) Registrant - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491) Establishment Name Address ID/FEI Business Operations NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD 529334491 manufacture(47993-215)