ALBA TERRATINT GARNET 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.

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Alba TerraTint Garnet 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, Caprylic/Capric Triglyceride, Beeswax, Manganese Violet (CI 77742), Oryza Sativa (Rice) Bran Wax, Iron Oxides (CI 77491), Mentha Piperita (Peppermint) Oil*, Olea Europaea (Olive) Fruit Oil, Calendula Officinalis Flower Extract, Echinacea Purpurea Extract, Stevia Rebaudiana (Stevia) Leaf/Stem Extract*, Polyhydroxystearic Acid, Polyglyceryl-3 Diisostearate, Tocopheryl Acetate, Triethoxycaprylylsilane, Limonene*, Linalool*, Iron Oxides (CI77499),  Mica (CI 77019), Titanium Dioxide (CI 77891). *Certified Organic Ingredient

Other Information

Protect this product from excessive heat and direct sun

Questions?

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

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ALBA TERRATINT GARNET SPF 15 LIP BALM 
zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0304
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
COCONUT OIL (UNII: Q9L0O73W7L)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
RICE BRAN (UNII: R60QEP13IC)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MICA (UNII: V8A1AW0880)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
LIMONENE, (+/-)- (UNII: 9MC3I34447)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
ECHINACEA PURPUREA (UNII: QI7G114Y98)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51514-0304-14.2 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/01/2012
Labeler - Autumn Harp, Inc. (064187883)
Establishment
NameAddressID/FEIBusiness Operations
Autumn Harp, Inc.064187883manufacture(51514-0304)

Revised: 9/2013
Document Id: 374b5d5c-2bbb-4106-a804-ff355ab75105
Set id: 8f89ee74-8fa1-46e4-a611-d3cb88f248aa
Version: 1
Effective Time: 20130916
 
Autumn Harp, Inc.