ELF Mineral Lip Tint SPF 8 by J. A. Cosmetics U.S. INC / Shanghai J. A. Cosmetics Trading CO., LTD. Drug Fact

ELF Mineral Lip Tint SPF 8 by

Drug Labeling and Warnings

ELF Mineral Lip Tint SPF 8 by is a Otc medication manufactured, distributed, or labeled by J. A. Cosmetics U.S. INC, Shanghai J. A. Cosmetics Trading CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ELF MINERAL LIP TINT SPF 8 - titanium dioxide powder 
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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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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
MICA (UNII: V8A1AW0880)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PETROLATUM (UNII: 4T6H12BN9U)
SHEA BUTTER (UNII: K49155WL9Y)
COCONUT OIL (UNII: Q9L0O73W7L)
JOJOBA OIL (UNII: 724GKU717M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-010-01	2.8 g in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2011	12/31/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/01/2011	12/31/2017

Labeler - J. A. Cosmetics U.S. INC (186705047)

Revised: 4/2012

Document Id: d0c1d335-4e23-4197-9db4-613d4b9ae8e4

34390-5

Set id: 31ab5874-0a03-4572-8e1a-e52074fe1bd2

Version: 3

Effective Time: 20120418

 

J. A. Cosmetics U.S. INC