Label: ALBA VERY EMOLLIENT SUNSCREEN LIP CARE SPF25- octocrylene, octinoxate, octisalate, zinc oxide stick
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Contains inactivated NDC Code(s)
NDC Code(s): 51514-0306-1 - Packager: Autumn Harp, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 September 17, 2013
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- Active Ingredient
- Purpose
- Uses
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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. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging.
- Directions
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Inactive Ingredients
Beeswax*, Helianthus Annuus (Sunflower) Seed Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*, Olea Europaea (Olive) Fruit Oil*, Ricinus Communis (Castor) Seed Oil*, C12-15 Alkyl Benzoate, Flavor*, Euphorbia Cerifera (Candelilla) Wax, Copernicia Cerifera (Carnauba) Wax*, Butyrospermum Parkii (Shea Butter)*, Theobroma Cacao (Cocoa) Seed Butter*, Glycine Soya (Soybean) Oil, Oenothera Biennis (Evening Primrose) Oil, Aloe Barbadensis Leaf Extract*, Calendula Officinalis Flower Extract, Echinacea Purpurea Extract, Allantoin, Ammonium Glycyrrhizate, Tocopherol, Polyhydroxystearic Acid, Triethoxycaprylylsilane, Iron Oxides (CI 77491), * Certified Organic Ingredient
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INGREDIENTS AND APPEARANCE
ALBA VERY EMOLLIENT SUNSCREEN LIP CARE SPF25
octocrylene, octinoxate, octisalate, zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51514-0306 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10.0 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.0 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC Oxide - UNII:SOI2LOH54Z) ZINC OXIDE 3.7 g in 100 g Inactive Ingredients Ingredient Name Strength YELLOW WAX (UNII: 2ZA36H0S2V) SUNFLOWER OIL (UNII: 3W1JG795YI) JOJOBA OIL (UNII: 724GKU717M) CASTOR OIL (UNII: D5340Y2I9G) OLIVE OIL (UNII: 6UYK2W1W1E) C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ) VANILLA (UNII: Q74T35078H) CANDELILLA WAX (UNII: WL0328HX19) CARNAUBA WAX (UNII: R12CBM0EIZ) SHEA BUTTER (UNII: K49155WL9Y) COCOA BUTTER (UNII: 512OYT1CRR) AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) EVENING PRIMROSE OIL (UNII: 3Q9L08K71N) ALLANTOIN (UNII: 344S277G0Z) ECHINACEA PURPUREA (UNII: QI7G114Y98) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) FERRIC OXIDE RED (UNII: 1K09F3G675) Aloe Vera Leaf (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Product Characteristics Color pink Score Shape Size Flavor VANILLA Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51514-0306-1 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 04/01/2012 Labeler - Autumn Harp, Inc. (064187883) Establishment Name Address ID/FEI Business Operations Autumn Harp, Inc. 064187883 manufacture(51514-0306)
