ELF LIP BALM SPF 15- oxybenzone cream

ELF Lip Balm SPF 15 by

Drug Labeling and Warnings

ELF Lip Balm SPF 15 by is a Otc medication manufactured, distributed, or labeled by Hangzhou Facecare Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:

Benzophenone-3: 4.5%

Ethylhexyl Methoxycinnamate: 5.0%

PURPOSE

Purpose:

Sunscreen

INDICATIONS & USAGE

Uses:

Applying on lip area helps prevent sunburn

WARNINGS

Warning:

For external use only

WHEN USING

When Using This Product:

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

ASK DOCTOR

Stop Use and Ask A Doctor If:

Rash or irritation develops and lasts

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:

Apply liberally as often as needed before sun exposure.

Reapply as needed or after swimming or towel drying

STORAGE AND HANDLING

Other Information

Store at room temperature 20-25 C (77-86F)

INACTIVE INGREDIENT

Inactive Ingredient:

Paraffinium Liquidum (Mineral Oil), hydrogenated Polyisobutene, Polyethylene Wax, Ceresine Wax, Copernicia Cerifera (Carnauba) Wax, Microcrystalline Wax, Mentha Piperita (Peppermint) Oil, Phenoxyethanol,  Methylparaben, Butylparaben, Ethylparaben, Propylparaben.

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

ELF LIP BALM SPF 15 
oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52664-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4.5 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYISOBUTYLENE (1200000 MW) (UNII: FLT10CH37X)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LIGHT MINERAL OIL (UNII: N6K5787QVP)	39.8 g  in 100 g
PEPPERMINT OIL (UNII: AV092KU4JH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLPARABEN (UNII: 14255EXE39)
BUTYLPARABEN (UNII: 3QPI1U3FV8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52664-008-01	3 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/01/2010

Labeler - Hangzhou Facecare Cosmetics Co., Ltd. (545341856)

Registrant - Hangzhou Facecare Cosmetics Co., Ltd. (545341856)

Establishment
Name	Address	ID/FEI	Business Operations
Hangzhou Facecare Cosmetics Co., Ltd.		545341856	manufacture