Label: GENERAL PROTECTION- avobenzone,octinoxate,octisalate,octocrylene gel
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Contains inactivated NDC Code(s)
NDC Code(s): 71153-2012-1 - 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 February 26, 2017
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- Sea & Ski SPF 30 Dry Gel Tube
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INGREDIENTS AND APPEARANCE
GENERAL PROTECTION
avobenzone,octinoxate,octisalate,octocrylene gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71153-2012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 3 g in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2 g in 1 mL Inactive Ingredients Ingredient Name Strength XANTHAN GUM (UNII: TTV12P4NEE) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71153-2012-1 44 mL in 1 TUBE; Type 0: Not a Combination Product 02/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/01/2017 Labeler - Cross-Brands Manufacturing LLC (080319350) Establishment Name Address ID/FEI Business Operations Cross-Brands Manufacturing LLC 080319350 manufacture(71153-2012) , label(71153-2012)
