ALBA MINERAL TERRA TINT SPF15 GARNET- zinc oxide cream 
The Hain Celestial Group, 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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Zinc Oxide 5.5%

Sunscreen

Cream. Apply liberally 15 minutes before sun exposure

For external use only. Do not use on damaged skin. When using this product keep out of eyes.

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

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

Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Beeswax, Caprylic/Capric Triglyceride, Mica, Titanium Dioxide, Oryza Sativa (Rice) Bran Wax, Mentha Pipperita (Peppermint) Oil (1), Olea Europaea (Olive) Fruit Oil, Calendula Officinalis Flower Extract, Echinacea Purpurea Extract, Stevia Rebaudiana Leaf/Stem Extract (1), Polyhydroxystearic Acid, Polyglyceryl-3 Diisostearate, Tocopheryl Acetate, Triethoxycaprylylsilane, Iron Oxides (CI 77491), Iron Oxides (CI 77499), Manganese Violet.

(1)-Certified Organic Ingredients.

jar label

ALBA MINERAL TERRA TINT SPF15 GARNET 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-2535
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
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
RICE BRAN (UNII: R60QEP13IC)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
ECHINACEA PURPUREA (UNII: QI7G114Y98)  
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
COCONUT OIL (UNII: Q9L0O73W7L)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
CANDELILLA WAX (UNII: WL0328HX19)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61995-2535-14.2 g in 1 JAR; Type 0: Not a Combination Product08/16/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/16/2013
Labeler - The Hain Celestial Group, Inc. (858894996)
Registrant - The Hain Celestial Group, Inc. (858894996)
Establishment
NameAddressID/FEIBusiness Operations
The Hain Celestial Group, Inc.858894996manufacture(61995-2535)

Revised: 10/2014
Document Id: 04f0d499-26fb-1d4c-e054-00144ff88e88
Set id: 04f0d499-26fa-1d4c-e054-00144ff88e88
Version: 1
Effective Time: 20141008
 
The Hain Celestial Group, Inc.