ALBA VERY EMOLLIENT SUNSCREEN LIP CARE SPF25- octocrylene, octinoxate, octisalate, zinc oxide stick

Alba Very Emollient Sunscreen Lip Care SPF25 by

Drug Labeling and Warnings

Alba Very Emollient Sunscreen Lip Care SPF25 by is a Otc medication manufactured, distributed, or labeled by Autumn Harp, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Octocrylene 10.0%

Ethylhexyl Methoxycinnamate 7.5%

Zinc Oxide 3.7%

Ethylhexyl Salicylate 1.0%

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Uses

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 doctor if skin rash occurs. Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging.

Directions

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

Inactive Ingredients

Beeswax*, Helianthus Annuus (Sunflower) Seed Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*, Olea Europaea (Olive) Fruit Oil*, Ricinus Communis (Castor) Seed Oil*, C12-15 Alkyl Benzoate, Flavor*, Euphorbia Cerifera (Candelilla) Wax, Copernicia Cerifera (Carnauba) Wax*, Butyrospermum Parkii (Shea Butter)*, Theobroma Cacao (Cocoa) Seed Butter*, Glycine Soya (Soybean) Oil, Oenothera Biennis (Evening Primrose) Oil, Aloe Barbadensis Leaf Extract*, Calendula Officinalis Flower Extract, Echinacea Purpurea Extract, Allantoin, Ammonium Glycyrrhizate, Tocopherol, Polyhydroxystearic Acid, Triethoxycaprylylsilane, Iron Oxides (CI 77491), * Certified Organic Ingredient

Other Information

Protect this product from excessive heat and direct sun

Questions?

Call (888) 659-7730 or visit www.albabotanica.com

Principal Display Panel

Image Components

INGREDIENTS AND APPEARANCE

ALBA VERY EMOLLIENT SUNSCREEN LIP CARE SPF25 
octocrylene, octinoxate, octisalate, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51514-0306
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10.0 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.0 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC Oxide - UNII:SOI2LOH54Z)	ZINC OXIDE	3.7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
SUNFLOWER OIL (UNII: 3W1JG795YI)
JOJOBA OIL (UNII: 724GKU717M)
CASTOR OIL (UNII: D5340Y2I9G)
OLIVE OIL (UNII: 6UYK2W1W1E)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
VANILLA (UNII: Q74T35078H)
CANDELILLA WAX (UNII: WL0328HX19)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SHEA BUTTER (UNII: K49155WL9Y)
COCOA BUTTER (UNII: 512OYT1CRR)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
ALLANTOIN (UNII: 344S277G0Z)
ECHINACEA PURPUREA (UNII: QI7G114Y98)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	VANILLA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51514-0306-1	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	04/01/2012

Labeler - Autumn Harp, Inc. (064187883)

Establishment
Name	Address	ID/FEI	Business Operations
Autumn Harp, Inc.		064187883	manufacture(51514-0306)