ELF SUPER GLOSSY LIP SHINE SPF 15- oxybenzone cream

ELF Super Glossy Lip Shine SPF 15 by

Drug Labeling and Warnings

ELF Super Glossy Lip Shine 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: 5.0%

Octyl Methoxycinnamate: 7.0%

PURPOSE

Purpose:

Sunscreen

INDICATIONS & USAGE

Uses:

• Brilliant, never sticky long lasting shine
• Moisturizes and soothes on contact
• Protects sun and skin aging
  

WARNINGS

Warning:

For external use only

WHEN USING

When using this product:

Do not get into eyes

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.

STORAGE AND HANDLING

Other Imformation:

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

INACTIVE INGREDIENT

Inactive Ingredient:

Paraffinium Liquidum (Mineral Oil), Polyisobutene, Silica, Mica, Fragrance, Methylparaben, Propylparaben.

May contain:

Iron Oxides (CI 77491, CI 77492, CI 77499), Manganese Violet (CI 77742), Mica (CI 77019), Red No. 7 Lake (CI 15850), Red No. 27 Lake (CI 45410), Red No. 6 Lake (CI 15851), Blue No. 1 Lake (CI 42090), Yellow No. 5 Lake (CI 19140), Yellow No. 6 Lake (CI 15985)

PRINCIPAL DISPLAY PANEL

label

INGREDIENTS AND APPEARANCE

ELF SUPER GLOSSY LIP SHINE SPF 15 
oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52664-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYISOBUTYLENE (1200000 MW) (UNII: FLT10CH37X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52664-001-01	10 g in 1 BOTTLE

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