ELF SUPER GLOSSY LIP SHINE SPF 15 - oxybenzone cream 
Hangzhou Facecare Cosmetics Co., Ltd.

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.

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Drug Fact

Active Ingredient:

Benzophenone-3: 5.0%

Octyl Methoxycinnamate: 7.0%

Purpose:

Sunscreen

Uses:

Warning:

For external use only

When using this product:

Do not get into eyes

Stop Use and Ask a Doctor if:

Rash or irritation develops and lasts

Keep Out of Reach of Children:

If swallowed get medical help or contact a Poison Control Center immediately

Directions:

Apply liberally as often as needed before sun exposure.

Other Imformation:

Store at room temperature 15-30C (59-86F)

Inactive Ingredient:

Paraffinium Liquidum (Mineral Oil), Polyisobutene, Silica, Mica, Fragrance, Methylparaben, Propylparaben.

May contain:

Iron Oxides (CI 77491, CI 77492, CI 77499), Manganese Violet (CI 77742), Mica (CI 77019), Red No. 7 Lake (CI 15850), Red No. 27 Lake (CI 45410), Red No. 6 Lake (CI 15851), Blue No. 1 Lake (CI 42090), Yellow No. 5 Lake (CI 19140), Yellow No. 6 Lake (CI 15985)

labellabel

ELF SUPER GLOSSY LIP SHINE SPF 15 
oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52664-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYISOBUTYLENE (1200000 MW) (UNII: FLT10CH37X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICA (UNII: V8A1AW0880)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52664-001-0110 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/01/2010
Labeler - Hangzhou Facecare Cosmetics Co., Ltd. (545341856)
Registrant - Hangzhou Facecare Cosmetics Co., Ltd. (545341856)
Establishment
NameAddressID/FEIBusiness Operations
Hangzhou Facecare Cosmetics Co., Ltd.545341856manufacture

Revised: 11/2010
Document Id: ec9df69b-cfb9-42b7-a934-d5823755720b
Set id: 6034e765-7ae6-420f-a9b6-68261de71966
Version: 1
Effective Time: 20101115
 
Hangzhou Facecare Cosmetics Co., Ltd.