FDA.reportPublic FDA data

Cream

Manufacturer
Oxygen Development LLC
Effective date
2023-02-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:53:55

Label at a glance#

ProductCream
Active ingredientZINC OXIDE
Label structure12 sections

Indications and uses

Help prevent sunburns if used as directed with other sun protection mesures (see Directions), decreases the risk of skin cancer and early aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply at least every two hours Use a water resistant sunscreen if swimming or sweating. Sun Protection Measures. Spending time in the sun increases you risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Board Spectrum SPF value 15 or higher and other sun protection measure including: Limit time in the sun, especially f...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20%

Purpose

OTC - PURPOSE SECTION

Sunscreen

uses

USER SAFETY WARNINGS SECTION

Help prevent sunburns

if used as directed with other sun protection mesures (see Directions), decreases the risk of skin cancer and early 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 on broken skin.

When using this product

OTC - WHEN USING SECTION

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

Stop use

OTC - STOP USE SECTION

stop use and ask a doctor if rash occurs

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure.
Reapply at least every two hours
Use a water resistant sunscreen if swimming or sweating.

Sun Protection Measures. Spending time in the sun increases you risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Board Spectrum SPF value 15 or higher and other sun protection measure including:

Limit time in the sun, especially from 10am to 2 pm

Wear long-sleeved shirt, pants, hats, and sunglasses

Children under 6 months: ask a doctor

Other information

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT SECTION

Water/Aqua, Caprylic/Capric Triglyceride, Isoamyl Laurate, Coconut Alkanes, Glycerin, Polyglyceryl-3 Polyricinoleate, Silica, Glyceryl Caprylate, Lecithin, Rose (Rosa Damascena) Flower Extract, Algae, Aloe (Aloe Barbadensis) Leaf Juice, Isostearic Acid, Polyhydroxystearic Acid, Sunflower (Helianthus Annuus) Seed Oil, Sweet Iris (Iris Pallida) Leaf Cell Extract, Polyglyceryl-6 Polyricinoleate, Sodium Chloride, Coco-Caprylate/Caprate, Kukui (Aleurites Moluccanus) Seed Oil, Pumpkin (Cucurbita Pepo) Seed Oil, Squalane, Xanthan Gum, Tamanu (Calophyllum Inophylum) Seed Oil, Pomegranate (Punica Granatum) Extract, Chaparral (Larrea Tridentata) Extract, Leuconostoc/Radish Root Ferment Filtrate, Bisabolol, Tocopherol, Sodium Hyaluronate, Citric Acid

Secondary package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61354-033-01_AW61354-033-01_AW27 ml 61354-033-01

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61354-033-012025-01-30C16284748780-1f386c649-d4b6-0266-e053-dadaa90a7c1aKYPRIS POT OF SHADE HELIOTROPIC BROAD SPECTRUM SPF30 SUNSCREEN & PRIMER
61354-033-012023-02-10C16284748780-1f386c649-d4b6-0266-e053-dadaa90a7c1aKYPRIS POT OF SHADE HELIOTROPIC BROAD SPECTRUM SPF30 SUNSCREEN & PRIMER
61354-033-012023-01-30C16284748780-1f386c649-d4b6-0266-e053-dadaa90a7c1aKYPRIS POT OF SHADE HELIOTROPIC BROAD SPECTRUM SPF30 SUNSCREEN & PRIMER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61354-033-01Cream3 mg in 1 JARCREAM32
61354-033-01Cream1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61354-033CREAM (ZINC OXIDE) CREAM [OXYGEN DEVELOPMENT LLC]2Legacy NDC, 2 package rows20230211_bc31db8a-f6d5-fd4f-e053-2995a90ad4cc.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61354-03361354-033-01

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
NameUNIIKind
COCONUT ALKANES1E5KJY107TIACT
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ISOAMYL LAURATEM1SLX00M3MIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
SODIUM CHLORIDE451W47IQ8XIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
ISOSTEARIC ACIDX33R8U0062IACT
ROSA X DAMASCENA FLOWERJWB78P295AIACT
SUNFLOWER OIL3W1JG795YIIACT
POLYGLYCERYL-6 POLYRICINOLEATEYPM0ZOC2HRIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
GLYCERINPDC6A3C0OXIACT
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
f45d0098-02cf-f8d6-e053-2a95a90ae8aabc31db8a-f6d5-fd4f-e053-2995a90ad4cc2023-02-10WarningsExact identifier
spl id: f45d0098-02cf-f8d6-e053-2a95a90ae8aa
spl set id: bc31db8a-f6d5-fd4f-e053-2995a90ad4cc

Reported adverse events (FAERS/openFDA)#

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