GENERAL PROTECTION- avobenzone,octocrylene,octisalate,homosalate,octinoxate lotion 
Cross-Brand 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 Sunscreen Lotion SPF 70

Sea & Ski GP Sunscreen SPF 70

Sea & Ski SPF 70 Lotion

GENERAL PROTECTION 
avobenzone,octocrylene,octisalate,homosalate,octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71153-2002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8 g  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71153-2002-1237 mL in 1 BOTTLE; Type 0: Not a Combination Product12/23/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/23/2016
Labeler - Cross-Brand Manufacturing, LLC (080319350)
Establishment
NameAddressID/FEIBusiness Operations
Cross-Brand Manufacturing, LLC080319350label(71153-2002) , manufacture(71153-2002)

Revised: 12/2016
Document Id: 444b2f9d-8635-1111-e054-00144ff88e88
Set id: 444b2f9d-8634-1111-e054-00144ff88e88
Version: 1
Effective Time: 20161222
 
Cross-Brand Manufacturing, LLC