FDA.reportPublic FDA data

MOISTURIZER

Manufacturer
OXYGEN DEVELOPMENT, LLC
Effective date
2021-03-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:38:49

Label at a glance#

ProductMOISTURIZER
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer an 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, especiall...

Storage and handling

Proect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 22.40%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

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 liberally 15 minutes before sun exposure.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer an 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 10am-2pm
  • wear long-sleeved shirts, pants hats and sunglasses
  • Children under 6 months of age: Ask a doctor.

Other Information

STORAGE AND HANDLING SECTION

Proect this product from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water(Aqua), Caprylic/Capric Triglyceride, Coconut Alkanes, Cetearyl Alcohol, Glycerin, Aloe Barbadensis Leaf Juice, Pyrus Males (Apple) Fruit Extract, Coco-Glucoside, Lactobacillus Ferment, Rubus Idaeus(red Raspberry) Seed oil, Cocos Nucifera(Coconut) Liquid Endosperm, Curcuma Longa (Turmeric) Rhizomes Oil, Butyrospermum parkii nut Extract, Hydrolyzed Jojoba Esters, Tocopherol, Dipotassium Glycyrrhizate, Vanilla Planifolia Fruit Extract, Glycyrrhiza Glabra(Licorice) Root Extract, Butylene Glycol, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Coco-Caprylate/Caprate, Caprylyl/Capryl Glucoside, Sclerotium Gum, Cetearyl Glucoside, Ethylhexylglycerin, Xantham Gum, Octyldodecanol, Tapioca Startch, Citric Acid, Sorbitan Oleate, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate, May contain +/- Iron Oxides (CI 77491, CI 77492).

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free (877) 546-2582

Primary Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube_AWTube_AW7.5ml 61354-012-01

Secondary Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61354-012-01_AW161354-012-01_AW161354-012-01_AW261354-012-01_AW27.5ml 61354-012-01

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61354-012-012023-01-30C16284748780-1f386c64a-387f-0266-e053-dadaa90a7c1aSelf Reflect Probiotic Moisturizing Sunscreen Zinc Oxide Broad Spectrum SPF 32

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61354-012-01MOISTURIZER7.5 mg in 1 BOTTLECREAM7.51
61354-012-01MOISTURIZER1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61354-012MOISTURIZER (ZINC OXIDE) CREAM [OXYGEN DEVELOPMENT, LLC]1Legacy NDC, 2 package rows20210310_bcd4fedc-b3fc-e250-e053-2995a90ab1c0.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61354-01261354-012-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
COCONUT ALKANES1E5KJY107TIACT
ALOE VERA LEAFZY81Z83H0XIACT
APPLEB423VGH5S9IACT
COCO GLUCOSIDEICS790225BIACT
LACTOBACILLUS REUTERI9913I24QEEIACT

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
bcd4fedc-b3fd-e250-e053-2995a90ab1c0bcd4fedc-b3fc-e250-e053-2995a90ab1c02021-03-05WarningsExact identifier
spl id: bcd4fedc-b3fd-e250-e053-2995a90ab1c0
spl set id: bcd4fedc-b3fc-e250-e053-2995a90ab1c0

Reported adverse events (FAERS/openFDA)#

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