ALBA BOTANICA UN-PETROLEUM VANILLA SPF18 LIP BALM- ethylhexyl dimethyl paba, benzophenone-3 stick

Alba Botanica UN-petroleum Vanilla SPF18 Lip Balm by

Drug Labeling and Warnings

Alba Botanica UN-petroleum Vanilla SPF18 Lip Balm by is a Otc medication manufactured, distributed, or labeled by The Hain Celestial Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethylhexyl Dimethyl PABA       7.5%

Benzophenone-3      5.0%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn

WARNINGS

For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove.Stop use and ask a doctor if skin rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact Poison Center right away.

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Children under 6 mos ask a doctor.

Skin Protection Measures:Spending time in the sun increases your risk of skin cancer and early skin aging.

INACTIVE INGREDIENT

Ricinus Communis (Castor) Seed Oil, Beeswax, Euphorbia Cerifera (Candelilla) Wax, Cocos Nucifera (Coconut) Oil, Simmondsia Chinensis (Jojoba) Seed Oil (1), Lanolin,  Copernicia Cerifera (Carnauba) Wax, Glycine Soja (Soybean) Oil, Oenothera Biennis (Evening Primrose) Oil, Olea Europaea (0live)Fruit Oil, Echinacea Purpurea Extract, Vanilla Planifolia Fruit Extract, Ammonium Glycyrrhizate, Tocopherol, Tocopheryl Acetate.

(1) Certified Organic Ingredient

QUESTIONS

Questions? Call 888-659-7730 or visit www.AlbaBotanica.com

PRINCIPAL DISPLAY PANEL

       

INGREDIENTS AND APPEARANCE

ALBA BOTANICA UN-PETROLEUM VANILLA SPF18 LIP BALM 
ethylhexyl dimethyl paba, benzophenone-3 stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-2921
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ)	PADIMATE O	7.5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CASTOR OIL (UNII: D5340Y2I9G)
YELLOW WAX (UNII: 2ZA36H0S2V)
CANDELILLA WAX (UNII: WL0328HX19)
JOJOBA OIL (UNII: 724GKU717M)
LANOLIN (UNII: 7EV65EAW6H)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SOYBEAN OIL (UNII: 241ATL177A)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
OLIVE OIL (UNII: 6UYK2W1W1E)
ECHINACEA PURPUREA (UNII: QI7G114Y98)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
COCONUT OIL (UNII: Q9L0O73W7L)
VANILLA (UNII: Q74T35078H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-2921-1	1 in 1 CARTON
1		4.2 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/02/2011

Labeler - The Hain Celestial Group, Inc. (858894996)

Establishment
Name	Address	ID/FEI	Business Operations
The Hain Celestial Group, Inc.		858894996	manufacture