FDA.reportPublic FDA data

Broad Spectrum Moisturizing Sunscreen-SPF 15, Octinoxate, Oxybenzone

Manufacturer
Only Yourx, Inc.
Effective date
2020-01-23
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 23:03:25

Label at a glance#

ProductBroad Spectrum Moisturizing Sunscreen-SPF 15, Octinoxate, Oxybenzone
Active ingredientOCTINOXATE, OXYBENZONE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Octinoxate (Octyl Methoxycinnamate), Oxybenzone

INACTIVE INGREDIENT SECTION

Other Ingredients: Water, Isodecyl Neopentanoate, Diisopropyl Sebacate, Lauryl Lactate, Glycerin, Cetearyl Alcohol, Cetearyl Glucoside, Allantoin, Aloe Vera Powder, D-Panthenol, Sodium Edetate, Squalane, Cetyl Alcohol, Stearyl Alcohol, Polysorbate 60, Phenoxyethanol, Ethylhexylglycerin, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Hydroethylacrylate/Sodium Acryloyldimethyl Copolymer, Aminomethylpropanol

DOSAGE & ADMINISTRATION SECTION

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

INDICATIONS & USAGE SECTION

Broad spectrum UVA and UVB protection. Lightweight lotion suitable for even oily skin helps to protect damaging rays, moisture loss and premature aging of the skin

OTC - PURPOSE SECTION

Broad spectrum UVA and UVB protection

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 immediately.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BROAD SPECTRUM MOISTURIZING SPF 15BROAD SPECTRUM MOISTURIZING SPF 15

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70367-006-012022-07-29C16284748780-1e4f33bdf-a1e6-d8a0-e053-dadaa90a6e4e76416019-1c93-963f-e053-2a91aa0abf74
70367-006-042022-07-29C16284748780-1e4f33bdf-a1e6-d8a0-e053-dadaa90a6e4e76416019-1c93-963f-e053-2a91aa0abf74

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70367-006-01Broad Spectrum Moisturizing Sunscreen-SPF 15, Octinoxate, Oxybenzone30 mL in 1 TUBELOTION307
70367-006-04Broad Spectrum Moisturizing Sunscreen-SPF 15, Octinoxate, Oxybenzone120 mL in 1 TUBELOTION1207

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70367-006BROAD SPECTRUM MOISTURIZING SUNSCREEN-SPF 15, OCTINOXATE, OXYBENZONE (OCTINOXATE, OXYBENZONE) LOTION [ONLY YOURX, INC.]7Legacy NDC, 2 package rows20200124_76416019-1c93-963f-e053-2a91aa0abf74.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
70367-00670367-006-04, 70367-006-01

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
CETYL ALCOHOL936JST6JCNIACT
STEARYL ALCOHOL2KR89I4H1YIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
ISODECYL NEOPENTANOATEW60VYE24XCIACT
SQUALANEGW89575KF9IACT
ALOE VERA LEAFZY81Z83H0XIACT
PANTHENOLWV9CM0O67ZIACT
POLYSORBATE 60CAL22UVI4MIACT
PHENOXYETHANOLHIE492ZZ3TIACT
(C10-C30)ALKYL METHACRYLATE ESTERXH2FQZ38D8IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
DIISOPROPYL SEBACATEJ8T3X564IHIACT
LAURYL LACTATEG5SU0BFK7OIACT
GLYCERINPDC6A3C0OXIACT
CETEARYL ETHYLHEXANOATE9M64UO4C25IACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
ALLANTOIN344S277G0ZIACT

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
9cd57085-9020-9388-e053-2995a90a260076416019-1c93-963f-e053-2a91aa0abf742020-01-23WarningsExact identifier
spl id: 9cd57085-9020-9388-e053-2995a90a2600
spl set id: 76416019-1c93-963f-e053-2a91aa0abf74

Reported adverse events (FAERS/openFDA)#

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