ELF MINERAL MOISTURIZING LIP TINT SPF 8- titanium dioxide powder

ELF Mineral Moisturizing Lip Tint SPF 8 by

Drug Labeling and Warnings

ELF Mineral Moisturizing Lip Tint SPF 8 by is a Otc medication manufactured, distributed, or labeled by Shanghai Justking Enterprise Co. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:

Titanium Dioxide: 4%

PURPOSE

Purpose:

Sunscreen

INDICATIONS & USAGE

Uses:

Apply to lip area to prevent Sunburn

Apply on lips to hydrate, repair and relieve chapped lips.

WARNINGS

Warning:

For external use only

WHEN USING

When Using This Product:

Avoid contact with eyes. If contact occurs, rinse thoroughly with water

ASK DOCTOR

Discontinue use if signs of rash or irritation appear. If irritation or rash persists, consult a doctor.

KEEP OUT OF REACH OF CHILDREN

Keep Out of Reach of Children:

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

DOSAGE & ADMINISTRATION

Directions:

Twist up tube and apply to lip area.

Apply prior to sun exposure

Use as a touch-up tinted lip moisturizer throughout the day as often as needed.

STORAGE AND HANDLING

Other Imformation:

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

INACTIVE INGREDIENT

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)

PRINCIPAL DISPLAY PANEL

label

INGREDIENTS AND APPEARANCE

ELF MINERAL MOISTURIZING LIP TINT SPF 8 
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76166-002
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: 76166-002-01	2.8 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/01/2011

Labeler - Shanghai Justking Enterprise Co. Ltd. (421267459)

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Justking Enterprise Co. Ltd.		421267459	manufacture