Label: ALBA MINERAL TERRA TINT SPF15 GARNET- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 61995-2535-1 - Packager: The Hain Celestial Group, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated October 8, 2014
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- ACTIVE INGREDIENT
- PURPOSE
- DOSAGE & ADMINISTRATION
- WARNINGS
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
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.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALBA MINERAL TERRA TINT SPF15 GARNET
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-2535 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 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:61995-2535-1 4.2 g in 1 JAR; Type 0: Not a Combination Product 08/16/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/16/2013 Labeler - The Hain Celestial Group, Inc. (858894996) Registrant - The Hain Celestial Group, Inc. (858894996) Establishment Name Address ID/FEI Business Operations The Hain Celestial Group, Inc. 858894996 manufacture(61995-2535)