GENERAL PROTECTION- avobenzone,homosalate,octisalate,octinoxate,octocrylene aerosol, spray 
Cross-Brands Manufacturing LLC

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.

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Sea & Ski Cspray 50

SPF 50 Cspray

Sea Ski 50 CSpray

GENERAL PROTECTION 
avobenzone,homosalate,octisalate,octinoxate,octocrylene aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71153-2007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.1 g  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71153-2007-1170 g in 1 CAN; Type 0: Not a Combination Product01/04/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/04/2017
Labeler - Cross-Brands Manufacturing LLC (080319350)
Establishment
NameAddressID/FEIBusiness Operations
Cross-Brands Manufacturing LLC080319350manufacture(71153-2007) , label(71153-2007)

Revised: 1/2019
Document Id: 7ef772ff-3e5f-5b1c-e053-2a91aa0a35e7
Set id: 45502b91-65a7-7261-e054-00144ff88e88
Version: 2
Effective Time: 20190108
 
Cross-Brands Manufacturing LLC