SAWYER SPF 30- oxybenzone, octisalate, octinoxate, homosalate lotion

Sawyer SPF 30 by

Drug Labeling and Warnings

Sawyer SPF 30 by is a Otc medication manufactured, distributed, or labeled by Cross Brands Contract Filling. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

Sawyer 4oz Bottle

INGREDIENTS AND APPEARANCE

SAWYER SPF 30 
oxybenzone, octisalate, octinoxate, homosalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73440-1184
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	37.84 g  in 946 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	47.3 g  in 946 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	70.95 g  in 946 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	94.6 g  in 946 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	506.49 g  in 946 g

Product Characteristics
Color	white (Opaque Lotion)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73440-1184-1	188.29 g in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/12/2021

SAWYER SPF 30 
oxybenzone, octisalate, octinoxate, homosalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73440-1188
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	37.84 g  in 946 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	47.3 g  in 946 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	70.95 g  in 946 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	94.6 g  in 946 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	506.49 g  in 946 g

Product Characteristics
Color	white (Opaque Lotion)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73440-1188-1	946 g in 1 JUG; Type 0: Not a Combination Product	05/06/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/06/2020

Labeler - Cross Brands Contract Filling (117871824)

Establishment
Name	Address	ID/FEI	Business Operations
Cross Brands Contract Filling		117871824	manufacture(73440-1188, 73440-1184) , label(73440-1188, 73440-1184) , pack(73440-1188, 73440-1184)