Label: ALBA TERRATINT BLOOM SPF 15 LIP BALM- zinc oxide stick
-
Contains inactivated NDC Code(s)
NDC Code(s): 51514-0303-1 - Packager: Autumn Harp, Inc.
- Category: HUMAN OTC DRUG LABEL
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 September 13, 2013
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
-
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
- Questions?
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
ALBA TERRATINT BLOOM SPF 15 LIP BALM
zinc oxide stickProduct 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)
