ELAVE AGE DELAY DAILY LIP DEFENCE SPF20- octinoxate, zinc oxide ointment

elave Age Delay Daily Lip Defence by

Drug Labeling and Warnings

elave Age Delay Daily Lip Defence by is a Otc medication manufactured, distributed, or labeled by Ovelle Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

DRUG FACTS

ACTIVE INGREDIENTS                               PURPOSE

Octinoxate 7.5%w/w                                   Sunscreen

Zinc Oxide 4.0%w/w                                   Sunscreen

PURPOSE

USES

• helps protect against sunburn
  
• for lips that sunburn easily
• helps provide protection against UVA and UVB rays

WARNINGS

WARNINGS

For external use only

Do not use on

• broken skin
• serious burns

When using this product

• keep out of the eyes. Rinse with water to remove
• not suitable for ingestion

Stop use and ask a doctor if

• rash or irritation develops and lasts

Keep out of reach of children

If swallowed get medical help or contact a Poison Control Center right away

WHEN USING

DIRECTIONS

• apply to lips 15 - 20 minutes before sun exposure
• re-apply as needed, especially after prolonged sun exposure, drinking or eating

OTHER SAFETY INFORMATION

OTHER INFORMATION

• store below 25C, do not freeze
• not recommended for children under 6 months of age

INACTIVE INGREDIENT

INACTIVE INGREDIENTS

Ricinus Communis (Castor) Seed Oil, Hydrogenated Castor Oil, Cera Alba (Beeswax), Oryza Sativa (Rice) Bran Wax, Butyrospermum Parkii (Shea Butter), Stearyl Dimethicone, Copernicia Cerifera (Carnauba) Wax, Dipalmitoyl Hydroxyproline, Phenyl Trimethicone, Bixa Orellana Seed Oil, Mentha Piperita (Peppermint Oil), Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, Cocos Nucifera (Coconut) Oil, BHT, Triethoxycaprylylsilane

QUESTIONS

QUESTIONS OR COMMENTS

Distributor: Ashette LLC, 27-28 Thomson Ave, Long Island City NY11101

www.ashette.com

Manufacturer: Ovelle Pharmaceuticals, Coes Road, Dundalk, Co Louth, Ireland

PRINCIPAL DISPLAY PANEL

age delay daily lip defence

SPF20

Sensitive Formula

Broad-Spectrum UVA/UVB Protection

Preservative Fee

Anti-oxidant Vitamin E

Soothing Aloe Vera Leaf Extract

Triple Firming Natural Lipoamino Acid

Refreshing Peppermint Oil

FREE FROM

Parabens, Alcohol, Sulfates, SLES/SLS, Formaldehyde, Dyes, Colours, Phthalates, Lanolin, Fragrance

PRINCIPAL DISPLAY PANEL

4600600201

INGREDIENTS AND APPEARANCE

ELAVE AGE DELAY DAILY LIP DEFENCE  SPF20
octinoxate, zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46006-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	1.125 mL  in 15 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.6 mL  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
Castor Oil (UNII: D5340Y2I9G)
Hydrogenated Castor Oil (UNII: ZF94AP8MEY)
Yellow Wax (UNII: 2ZA36H0S2V)
Rice Bran (UNII: R60QEP13IC)
Shea Butter (UNII: K49155WL9Y)
Dimethicone (UNII: 92RU3N3Y1O)
Carnauba Wax (UNII: R12CBM0EIZ)
Dipalmitoyl Hydroxyproline (UNII: E6AHA53N1H)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Bixa Orellana Seed Oil (UNII: 3R3HS2KR6P)
Peppermint Oil (UNII: AV092KU4JH)
Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Coconut Oil (UNII: Q9L0O73W7L)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Triethoxycaprylylsilane (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46006-002-01	15 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/20/2011

Labeler - Ovelle Ltd (219542784)

Registrant - Ovelle Ltd (219542784)

Establishment
Name	Address	ID/FEI	Business Operations
Ovelle Ltd		219542784	manufacture