ELF Mineral Lip Tint SPF 8

Dosage form: powder
Ingredients: TITANIUM DIOXIDE 4g in 100g
Labeler: J. A. Cosmetics U.S. INC
NDC Code: 76354-010

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 Fact

Active Ingredient:

Titanium Dioxide: 4%

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 and early skin aging. This product has been shown to help prevent sunburn, not skin cancer or akin 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 generally 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 this product in this container from excessive heat and direct sun

Inactive Ingredient:

Paraffinium Liquidum (Mineral Oil), Caprylic/Capric Triglyceride, Iso-Octyl Palmitate, Synthetic Wax, Microcrystalline Wax, Petrolatum, Bis-Diglyceryl Polyacyladipate-2, Butyrospermum Parkli (Shea Butter), Tocopheryl Acetate, Cocos Nucifere (Coconut) Oil, Simmondsia Chinensis (Jojoba) Seed Oil.

May contain:

Iron Oxides (CI 77491, CI 77492, CI 77499), Manganese Violet (CI 77742), Mica (CI 77019)

label

ELF MINERAL LIP TINT SPF 8 
titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76354-010
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
MICA 
ETHYLHEXYL PALMITATE 
FERRIC OXIDE YELLOW 
MICROCRYSTALLINE WAX 
MEDIUM-CHAIN TRIGLYCERIDES 
PETROLATUM 
SHEA BUTTER 
COCONUT OIL 
JOJOBA OIL 
Packaging
#Item CodePackage Description
1NDC:76354-010-012.8 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/2011
Labeler - J. A. Cosmetics U.S. INC (186705047)
Registrant - J. A. Cosmetics U.S. INC (186705047)
Establishment
NameAddressID/FEIOperations
Shanghai J. A. Cosmetics Trading CO., LTD.421280183manufacture

Revised: 04/2012
 
J. A. Cosmetics U.S. INC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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