FDA.reportPublic FDA data

Zinc Oxide, Octinoxate, Octisalate, Oxybenzone

Manufacturer
Only Yourx, Inc.
Effective date
2020-01-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:03:25

Label at a glance#

ProductOil Free Matte Sunscreen SPF 30, - Zinc Oxide, Octinoxate, Octisalate, Oxybenzone
Active ingredientOCTINOXATE, OCTISALATE, OXYBENZONE, ZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Protects against UVA/UVB rays

INDICATIONS & USAGE SECTION

Protects against skin-aging UVA/UVB rays with advanced, broad-spectrum sunscreens and powerful antioxidants. Lightweight and water-resistant, this formula won't clog pores to help prevent breakouts. Leaves a matte finish

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Zinc Oxide, Octinoxate (Octyl Methoxycinnamate), Octisalate (Octyl Salicylate), Oxybenzone

INACTIVE INGREDIENT SECTION

SLauryl Lactate, Isodecyl Neopentanoate, Diisopropyl Sebacate, Cetearyl Alcohol, Ceteareth-20, Cetyl Octanoate, Glyerin, Stearyl Alcohol, Cetyl Alcohol, Boron Nitride, Nylon 12, Vitamin E Tocopheryl Acetate, Allantoin, Alpha-Bisabolol, Pine Bark Extract, Green Tea Extract, Licorice Extract, Rosehips Extract, Passion Flower Extract, Butylene Glycol, Disodium EDTA, Xanthan Gum, Magnesium Aluminum Silicate, Triethoxycaprylsilane, Laureth-7, Ethylhexylglycerin, Phenoxyethanol, Polyacrylamide/C13-14 Isoparaffin

DOSAGE & ADMINISTRATION SECTION

Apply a liberal amount approximately 30 minutes prior to sun exposure. For continuous protection, reapply regularly and after swimming and/or exercising

WARNINGS SECTION

Warnings: For external use only; Do not use on damaged or broken skin; Stop use and ask a doctor if rash occurs; When using this product keep out of eyes; Rinse with water to remove

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OIL FREE MATTE SPF 30OIL FREE MATTE SPF 30

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70367-007-012022-07-29C16284748780-1e4f33bdf-a946-d8a0-e053-dadaa90a6e4e76444f6a-1d87-44cc-e053-2a91aa0a43d6
70367-007-042022-07-29C16284748780-1e4f33bdf-a946-d8a0-e053-dadaa90a6e4e76444f6a-1d87-44cc-e053-2a91aa0a43d6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70367-007-01Oil Free Matte Sunscreen SPF 30, - Zinc Oxide, Octinoxate, Octisalate, Oxybenzone30 mL in 1 TUBELOTION304
70367-007-04Oil Free Matte Sunscreen SPF 30, - Zinc Oxide, Octinoxate, Octisalate, Oxybenzone120 mL in 1 TUBELOTION1204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70367-007OIL FREE MATTE SUNSCREEN SPF 30, - ZINC OXIDE, OCTINOXATE, OCTISALATE, OXYBENZONE (ZINC OXIDE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [ONLY YOURX, INC.]4Legacy NDC, 2 package rows20200124_76444f6a-1d87-44cc-e053-2a91aa0a43d6.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70367-00770367-007-04, 70367-007-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOXYETHANOLHIE492ZZ3TIACT
OCTINOXATE4Y5P7MUD51ACTIB
ETHYLHEXYLGLYCERIN147D247K3PIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
LICORICE61ZBX54883IACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
WATER059QF0KO0RIACT
LAURYL LACTATEG5SU0BFK7OIACT
GLYCERINPDC6A3C0OXIACT
CETYL ALCOHOL936JST6JCNIACT
XANTHAN GUMTTV12P4NEEIACT
OCTISALATE4X49Y0596WACTIB
OXYBENZONE95OOS7VE0YACTIB
ISODECYL NEOPENTANOATEW60VYE24XCIACT
DIISOPROPYL SEBACATEJ8T3X564IHIACT
STEARYL ALCOHOL2KR89I4H1YIACT
SQUALANEGW89575KF9IACT
POLYSORBATE 60CAL22UVI4MIACT
ZINC OXIDESOI2LOH54ZACTIB

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9cd5746c-8c92-918b-e053-2995a90ada7a76444f6a-1d87-44cc-e053-2a91aa0a43d62020-01-23WarningsExact identifier
spl id: 9cd5746c-8c92-918b-e053-2995a90ada7a
spl set id: 76444f6a-1d87-44cc-e053-2a91aa0a43d6

Reported adverse events (FAERS/openFDA)#

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