SAWYER SPF 30- oxybenzone, octisalate, octinoxate, homosalate lotion 
Cross Brands Contract Filling

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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Sawyer SPF 30 Sunscreen

Package Label- Principle Display Panel

Sawyer 4oz Bottle

Sawyer4ozBottle

SAWYER SPF 30 
oxybenzone, octisalate, octinoxate, homosalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73440-1184
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE37.84 g  in 946 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE47.3 g  in 946 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE70.95 g  in 946 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE94.6 g  in 946 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 506.49 g  in 946 g
Product Characteristics
Colorwhite (Opaque Lotion) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73440-1184-1188.29 g in 1 BOTTLE; Type 0: Not a Combination Product04/13/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/12/2021
SAWYER SPF 30 
oxybenzone, octisalate, octinoxate, homosalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73440-1188
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE37.84 g  in 946 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE47.3 g  in 946 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE70.95 g  in 946 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE94.6 g  in 946 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 506.49 g  in 946 g
Product Characteristics
Colorwhite (Opaque Lotion) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73440-1188-1946 g in 1 JUG; Type 0: Not a Combination Product05/06/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/06/2020
Labeler - Cross Brands Contract Filling (117871824)
Establishment
NameAddressID/FEIBusiness Operations
Cross Brands Contract Filling117871824manufacture(73440-1188, 73440-1184) , label(73440-1188, 73440-1184) , pack(73440-1188, 73440-1184)

Revised: 4/2021
Document Id: bfccd7d2-4902-199a-e053-2995a90ae500
Set id: be74d517-7f74-a74c-e053-2a95a90a3819
Version: 2
Effective Time: 20210412
 
Cross Brands Contract Filling