CREAM- octinoxate, oxybenzone cream

cream by

Drug Labeling and Warnings

cream by is a Otc medication manufactured, distributed, or labeled by Oxygen Development. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Octinoxate 7.5

Oxybenzone 2.0

Purpose

Sunscreen

Uses

helps prevent sunburn. Provides moderate protection against sunburn.

Directions

Apply and blend evenly onto the face. Use over Studiomakeup soft illusion Face Primer for a flawless and smooth finish

Ingredients

Water/Aqua, phenyl trimethicone, ethylhexyl methoxycinnamate, dimethicone, dicaprylyl ether, boron nitride, benzophenone-3, polymethylsilsesquioxane, silica, mica, aloe barbadensis leaf juice, disteardimonium hectorite, phenoxyethanol, dimethicone/PEG-10/15 crosspolymer, isododecane, sodium chloride, polyglyceryl-4 isostearate, hexyl laurate, cetyl PEG/PPG-10/1 dimethicone, propylene carbonate, dimethicone crosspolymer, polyethylene, polysilicone-11, ethylhexyglycerin, aluminum dimyristate, triehoxycaprylylsilane,disodium stearoyl glutamate, disodium EDTA, citric acid, potassium sorbate, sodium benzoate, sodium hyaluronate. May contain [+/-]: titanium dioxide CI 77891, iron oxides CI 77491/ CI 77492/ CI 77499

package

INGREDIENTS AND APPEARANCE

CREAM 
octinoxate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61354-026
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 mg  in 100 mg
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.49 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
MICA (UNII: V8A1AW0880)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
BORON NITRIDE (UNII: 2U4T60A6YD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61354-026-01	30 mg in 1 TUBE; Type 0: Not a Combination Product	02/23/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/23/2021

Labeler - Oxygen Development (137098492)

Establishment
Name	Address	ID/FEI	Business Operations
Oxygen Development		137098492	manufacture(61354-026)