Label: GENERAL PROTECTION- avobenzone,octocrylene,octisalate,homosalate,octinoxate lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 71153-2004-1 - 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 December 22, 2016
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- Official Label (Printer Friendly)
- Sea & Ski Sport Lotion SPF 50
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INGREDIENTS AND APPEARANCE
GENERAL PROTECTION
avobenzone,octocrylene,octisalate,homosalate,octinoxate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71153-2004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5 g in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71153-2004-1 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/23/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/23/2016 Labeler - Cross-Brands Manufacturing, LLC (080319350) Establishment Name Address ID/FEI Business Operations Cross-Brands Manufacturing, LLC 080319350 label(71153-2004) , manufacture(71153-2004)
