Octinoxate and Zinc Oxide

Manufacturer
Cosmetic Solutions LLC
Effective date
2019-10-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:00:40

Label at a glance#

ProductMenaji Power Hydrator Plus Sunscreen Broad Spectrum SPF 30 Plus Tinted Moisturize Medium
Active ingredientOctinoxate, Zinc Oxide
Label structure10 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

Apply generously until desired coverage is achieved. If exposed to sun, reapply every 2 hours. If swimming or sweating, use water resistant sunscreen. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the...

Storage and handling

Protect the product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS:

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Octyl Methoxycinnamate 7.5%

Zinc Oxide 7.0%

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

USES

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

WARNINGS

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Apply generously until desired coverage is achieved. If exposed to sun, reapply every 2 hours. If swimming or sweating, use water resistant sunscreen. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water (Aqua), Stearyl Alcohol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Glyceryl Dilaurate, Cetearyl Alcohol, Beeswax, Dimethicone, Cyclomethicone, Diisopropyl Adipate, Hexylene Glycol, PEG-40 Stearate, C12-15 Alkyl Benzoate, Aluminum Starch Octenylsuccinate, PEG-20, Carnauba Wax, Dimethicone Copolyol, VP/ Eicosene Copolymer, Sorbitan Tristearate, Stearoxytrimethylsilane, Steareth-100, Laureth-7, C13-14 Isoparaffin, Phenoxyethanol, Ethylhexylglycerin, Polyacrylamide, Iron Oxides (CI77491), (CI77492) (CI77499).

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Protect the product in this container from excessive heat and direct sun.

SPL UNCLASSIFIED SECTION

Distr. by Manaji Worldwide, LLC. Southport, CT 06890 USA

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MËNAJI™
ADVANCED MEN'S SKINCARE

Power
Hydrator
PLUS

Sunscreen
Broad Spectrum SPF 30
+ Tinted Moisturizer

MEDIUM

2 FL. OZ. / 60 mL e

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66163-7621-22021-01-29C16284748780-1ba0f9c33-5bc2-a910-e053-dadaa90a0b85Mënaji™ – Power Hydrator Plus Sunscreen Broad Spectrum SPF 30 + Tinted Moisturize Medium

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66163-7621-2Menaji Power Hydrator Plus Sunscreen Broad Spectrum SPF 30 Plus Tinted Moisturize Medium60 mL in 1 BOTTLE, PLASTICCREAM601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66163-7621MENAJI POWER HYDRATOR PLUS SUNSCREEN BROAD SPECTRUM SPF 30 PLUS TINTED MOISTURIZE MEDIUM (OCTINOXATE AND ZINC OXIDE) CREAM [COSMETIC SOLUTIONS LLC]1Legacy NDC, 1 package rows20191002_8136fcde-40da-4fae-b661-1b005b150bbc.zip

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66163-762166163-7621-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

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
190be4de-f83b-43df-9483-121a824d48138136fcde-40da-4fae-b661-1b005b150bbc2019-10-01WarningsExact identifier
spl id: 190be4de-f83b-43df-9483-121a824d4813
spl set id: 8136fcde-40da-4fae-b661-1b005b150bbc

Reported adverse events (FAERS/openFDA)#

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