ALBA TERRATINT BLOOM SPF 15 LIP BALM- zinc oxide stick 
Autumn Harp, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Alba TerraTint Bloom SPF 15 Lip Balm

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

image description

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 DEA Schedule     
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)

Revised: 9/2013
Document Id: 2bab63e9-ca01-4cf7-af4e-3d2d106f9bb3
Set id: 8327fe5f-8d4b-49d9-8a47-11919cfc00bf
Version: 1
Effective Time: 20130913
 
Autumn Harp, Inc.