ELF SUPER GLOSSY LIP SHINE SPF 15- oxybenzone and octinoxate cream 
J. A. Cosmetics U.S. INC

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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Active Ingredient:

OXYBENZONE: 6.0%

Octyl Methoxycinnamate: 7.5%

Purpose:

Sunscreen

Uses: Help prevent sunburn

Warning:

For external use only

Skin Cancer/Skin Aging Alert:

Spending time in the sun increases your risk of skin cancer or early skin aging. This product has been shown to only help prevent sunburn, not skin cancer or skin aging.

When using this product:

Keep out of eyes. Rinse with water to remove.

Stop Use and Ask a Doctor if:

Rash occurs

Keep Out of Reach of Children

Directions:

  • Apply generously 15 min before sun exposure
  • Children under six months of age: ask a doctor
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating

Other Information:

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredient:

Paraffinium Liquidum (Mineral Oil), Polyisobutene, Ethylhexyl Palmitate, Aspartame, Silica, Quartz, Tin Oxide.

May contain:

Mica, Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (77891), Red 6 Lake (CI 15851), Red 7 Lake (CI 15850), Yellow 5 Lake (CI 19140), Red 28 Lake (CI 45410), Red 36 Lake (CI 12085)

2800 Super glossy SPF_1028_Back

2800 Super glossy SPF_1028_Front

ELF SUPER GLOSSY LIP SHINE SPF 15 
oxybenzone, octinoxate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:76354-105
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBENZONE (OXYBENZONE) OXYBENZONE6 g  in 100 g
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYISOBUTYLENE (1100000 MW) 
SILICON DIOXIDE 
MICA 
METHYLPARABEN 
PROPYLPARABEN 
LIGHT MINERAL OIL 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76354-105-511 in 1 BOX
1NDC:76354-105-0110 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/09/2011
Labeler - J. A. Cosmetics U.S. INC (186705047)
Registrant - J. A. Cosmetics U.S. INC (186705047)
Establishment
NameAddressID/FEIBusiness Operations
Shanghai J. A. Cosmetics Trading CO., LTD. 421280183manufacture(76354-105)

Revised: 3/2014
Document Id: 2b76adce-e733-414a-a3ba-6d680bf5e9d8
Set id: edcec7df-5fed-4ec8-8bc1-32b6508c71c7
Version: 2
Effective Time: 20140321
 
J. A. Cosmetics U.S. INC