ALBA TERRATINT BLOOM SPF 15 LIP BALM- zinc oxide stick

Alba TerraTint Bloom SPF 15 Lip Balm by

Drug Labeling and Warnings

Alba TerraTint Bloom SPF 15 Lip Balm by is a Otc medication manufactured, distributed, or labeled by Autumn Harp, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Zinc Oxide 5.5%

Purpose

Sunscreen

Uses

Helps prevent sunburn
If used as directed with other sun protection measures (see Directions), decreases risk of skin cancer and early skin aging caused by sun exposure.

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. 

Directions

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Children under 6 months: ask a doctor. Skin Protection Measures: Spending time in sun increases risk of skin cancer and early skin aging. To decrease risk, use sunscreen with Broad Spectrum SPF 15 or higher, limit time in sun, especially 10am-2pm, and wear hats and sunglasses. 

Inactive Ingredients

Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Beeswax, Caprylic/Capric Triglyceride, Mica(Cl 77019), Titanium Dioxide(Cl 77891), Oryza Sativa (Rice) Bran Wax, Mentha Piperita (Peppermint) Oil*, Olea Europaea (Olive) Fruit Oil, Calendula Officinalis Flower Extract, Echinacea Purpurea Extract, Stevia Rebaudiana Leaf/Stem Extract*, Polyhydroxystearic Acid, Polyglyceryl-3 Diisostearate, Tocopheryl Acetate, Triethoxycaprylylsilane, Limonene*, Linalool*, 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 TERRATINT BLOOM SPF 15 LIP BALM 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51514-0303
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
COCONUT OIL (UNII: Q9L0O73W7L)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
RICE BRAN (UNII: R60QEP13IC)
PEPPERMINT OIL (UNII: AV092KU4JH)
FERRIC OXIDE RED (UNII: 1K09F3G675)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLIVE OIL (UNII: 6UYK2W1W1E)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
ECHINACEA PURPUREA (UNII: QI7G114Y98)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51514-0303-1	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	08/01/2012

Labeler - Autumn Harp, Inc. (064187883)

Establishment
Name	Address	ID/FEI	Business Operations
Autumn Harp, Inc.		064187883	manufacture(51514-0303)