Label: ALBA HAWAIIANDRY SUNSCREEN SPF15- homosalate, octisalate, octocrylene, avobenzone oil
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Contains inactivated NDC Code(s)
NDC Code(s): 61995-2102-4 - Packager: The Hain Celestial Group, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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Drug Label Information
Updated January 22, 2014
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INGREDIENTS AND APPEARANCE
ALBA HAWAIIANDRY SUNSCREEN SPF15
homosalate, octisalate, octocrylene, avobenzone oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-2102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10.0 g in 133 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.0 g in 133 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 3.0 g in 133 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.0 g in 133 g Inactive Ingredients Ingredient Name Strength ETHYLHEXYL PALMITATE (UNII: 2865993309) SAFFLOWER OIL (UNII: 65UEH262IS) COCONUT OIL (UNII: Q9L0O73W7L) SHEA BUTTER (UNII: K49155WL9Y) CARROT SEED OIL (UNII: 595AO13F11) MACADAMIA OIL (UNII: 515610SU8C) TOCOPHEROL (UNII: R0ZB2556P8) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61995-2102-4 133 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/14/2014 Labeler - The Hain Celestial Group, Inc. (858894996) Establishment Name Address ID/FEI Business Operations The Hain Celestial Group, Inc. 858894996 manufacture(61995-2102)