cream

Manufacturer: Oxygen Development
Effective date: 2023-02-10
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:53:54

Label at a glance#

Productcream

Active ingredientOXYBENZONE, OCTINOXATE

Label structure6 sections

Indications and uses

helps prevent sunburn. Provides moderate protection against sunburn.

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5

Oxybenzone 2.0

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

helps prevent sunburn. Provides moderate protection against sunburn.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61354-022-01_AW61354-022-01_AW61354-022-01_AW61354-022-01_AW

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61354-026-01	2025-01-30	C162847	48780-1	f386c64a-2e5d-0266-e053-dadaa90a7c1a	Studiomakeup smooth perfection BB cream SPF 15 broad spectrum
61354-026-01	2023-02-10	C162847	48780-1	f386c64a-2e5d-0266-e053-dadaa90a7c1a	Studiomakeup smooth perfection BB cream SPF 15 broad spectrum
61354-026-01	2023-01-30	C162847	48780-1	f386c64a-2e5d-0266-e053-dadaa90a7c1a	Studiomakeup smooth perfection BB cream SPF 15 broad spectrum

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61354-026-01	cream	30 mg in 1 TUBE	CREAM	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61354-026	CREAM (OCTINOXATE, OXYBENZONE) CREAM [OXYGEN DEVELOPMENT]	2	Legacy NDC, 1 package rows	20230211_bc07accc-5605-6c68-e053-2995a90a0a7e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

cream
Octinoxate, Oxybenzone
DIMETHICONE
PHENYL TRIMETHICONE
SODIUM CHLORIDE
SILICON DIOXIDE
PHENOXYETHANOL
ALOE VERA LEAF
WATER
ISODODECANE
DIMETHICONE/PEG-10/15 CROSSPOLYMER
DISTEARDIMONIUM HECTORITE
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)
MICA
DICAPRYLYL ETHER
BORON NITRIDE
OXYBENZONE
OCTINOXATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61354-026	61354-026-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIMETHICONE	92RU3N3Y1O	IACT
PHENYL TRIMETHICONE	DR0K5NOJ4R	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
WATER	059QF0KO0R	IACT
ISODODECANE	A8289P68Y2	IACT
DIMETHICONE/PEG-10/15 CROSSPOLYMER	21AS8B1BSS	IACT
DISTEARDIMONIUM HECTORITE	X687XDK09L	IACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)	59Z907ZB69	IACT
MICA	V8A1AW0880	IACT
DICAPRYLYL ETHER	77JZM5516Z	IACT
BORON NITRIDE	2U4T60A6YD	IACT
OXYBENZONE	95OOS7VE0Y	ACTIB
OCTINOXATE	4Y5P7MUD51	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
f45d0878-c1b5-4f9e-e053-2a95a90a2aa6			bc07accc-5605-6c68-e053-2995a90a0a7e	2023-02-10		Exact identifier spl id: f45d0878-c1b5-4f9e-e053-2a95a90a2aa6 spl set id: bc07accc-5605-6c68-e053-2995a90a0a7e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.