Label: ELF LIP BALM SPF 15- oxybenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 52664-008-01 - Packager: Hangzhou Facecare Cosmetics 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 November 17, 2010
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ELF LIP BALM SPF 15
oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52664-008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 4.5 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 5 g in 100 g Inactive Ingredients Ingredient Name Strength POLYISOBUTYLENE (1200000 MW) (UNII: FLT10CH37X) CARNAUBA WAX (UNII: R12CBM0EIZ) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) LIGHT MINERAL OIL (UNII: N6K5787QVP) 39.8 g in 100 g PEPPERMINT OIL (UNII: AV092KU4JH) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLPARABEN (UNII: 14255EXE39) BUTYLPARABEN (UNII: 3QPI1U3FV8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52664-008-01 3 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/01/2010 Labeler - Hangzhou Facecare Cosmetics Co., Ltd. (545341856) Registrant - Hangzhou Facecare Cosmetics Co., Ltd. (545341856) Establishment Name Address ID/FEI Business Operations Hangzhou Facecare Cosmetics Co., Ltd. 545341856 manufacture