Label: GENERAL PROTECTION- avobenzone,homosalate,octisalate,octocrylene,octinoxate aerosol, spray
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Contains inactivated NDC Code(s)
NDC Code(s): 71153-2009-1 - Packager: Cross-Brands Manufacturing LLC
- 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 January 4, 2017
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- Sea & Ski SPF 50 Sport CSpray
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INGREDIENTS AND APPEARANCE
GENERAL PROTECTION
avobenzone,homosalate,octisalate,octocrylene,octinoxate aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71153-2009 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 1 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 1 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5 g in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.1 g in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71153-2009-1 170 g in 1 CAN; Type 0: Not a Combination Product 01/04/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/04/2017 Labeler - Cross-Brands Manufacturing LLC (080319350) Establishment Name Address ID/FEI Business Operations Cross-Brands Manufacturing LLC 080319350 label(71153-2009) , manufacture(71153-2009)
