Label: ALBA TERRATINT GARNET SPF 15 LIP BALM- zinc oxide stick
- NDC Code(s): 51514-0304-1
- Packager: Autumn Harp, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- Active Ingredient
Zinc Oxide 5.5%Close
• Helps prevent sunburnClose
• If used as directed with other sun protection measures (see Directions), decreases risk of skin cancer and early skin aging caused by sun exposure.
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.Close
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.Close
- 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 IngredientClose
- Other Information
Protect this product from excessive heat and direct sunClose
Call (888) 659-7730 or visit www.albabotanica.comClose
- Principal Display Panel
- INGREDIENTS AND APPEARANCE
ALBA TERRATINT GARNET SPF 15 LIP BALM
zinc oxide stick
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51514-0304 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 5.5 g in 100 g Inactive Ingredients Ingredient Name Strength COCONUT OIL SUNFLOWER OIL CANDELILLA WAX YELLOW WAX MEDIUM-CHAIN TRIGLYCERIDES MANGANESE VIOLET RICE BRAN FERRIC OXIDE RED PEPPERMINT OIL POLYHYDROXYSTEARIC ACID (2300 MW) TRIETHOXYCAPRYLYLSILANE ALPHA-TOCOPHEROL ACETATE MICA OLIVE OIL STEVIA REBAUDIUNA LEAF POLYGLYCERYL-3 DIISOSTEARATE TITANIUM DIOXIDE FERROSOFERRIC OXIDE LIMONENE, (+/-)- CALENDULA OFFICINALIS FLOWER ECHINACEA PURPUREA LINALOOL, (+/-)- 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:51514-0304-1 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(51514-0304)