FDA.reportPublic FDA data

Cream

Manufacturer
Oxygen Development LLC
Effective date
2023-10-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:58:10

Label at a glance#

ProductCream
Active ingredientZINC OXIDE
Label structure12 sections

Indications and uses

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

Dosage and administration

Apply liberally 15 minutes before sun exposure. Use water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Sun protection measures: Spending time in the sun increases 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 am-2 pm. -wear long-sleeved shirts, pants, hats a...

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 22.4%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Help prevent sunburn.

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin agung 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.

When using this product

OTC - WHEN USING SECTION

When using this product keep out of eyes.

Rinse with water to remove.

Stop use and ask a doctor

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

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 water resistant sunscreen if swimming or sweating.

Reapply at least every 2 hours.

Sun protection measures:

Spending time in the sun increases 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 am-2 pm.

-wear long-sleeved shirts, pants, hats and sunglasses.

-children under 6 months of age: Ask a doctor.

Other information

STORAGE AND HANDLING SECTION

Protect 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 Malus (Apple) Fruit Extract, Coco-Glucoside, Lactobacillus Ferment, Rubus Idaeus (Raspberry) Seed Oil, Cocos Nucifera (Coconut) Liquid Endosperm, Curcuma Longa (Turmeric) Rhizomes Oil, Butyrospermum Parkii Nut Extract, Hydrolyzed Jojoba Esters, Tocopherol, Dipotassium Glycyrrhizinate, 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, Glucoside, Sclerotium Gum, Cetearyl Glucoside, Ethylhexylglycerin, Xanthan Gum, Octyldodecanol, Tapioca Starch, Citric Acid, Sorbitan Oleate, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate, May contain +/- Iron Oxides (CI 77491, CI 77492) *Certified Organic.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61354-115-01-aw61354-115-01-aw61354-115-01_aw61354-115-01_aw

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61354-115-01Cream100 mg in 1 TUBECREAM1001
61354-115-02Cream1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61354-115CREAM (ZINC OXIDE) CREAM [OXYGEN DEVELOPMENT LLC]1Current NDC, 2 package rows20231030_08a1e862-b55a-fb84-e063-6294a90a016a.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61354-11561354-115-01, 61354-115-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
WATER059QF0KO0RIACT
APPLEB423VGH5S9IACT
COCO GLUCOSIDEICS790225BIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ZINC OXIDESOI2LOH54ZACTIB
COCONUT ALKANES1E5KJY107TIACT
RASPBERRY SEED OIL9S8867952AIACT
PHENOXYETHANOLHIE492ZZ3TIACT
LACTOBACILLUS REUTERI F275 STRAIN3K209OP33HIACT
GLYCERINPDC6A3C0OXIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ISOSTEARIC ACIDX33R8U0062IACT

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
CreamZINC OXIDEOxygen Development LLC08a1e862-b55a-fb84-e063-6294a90a016a2023-10-26WarningsExact identifier
ndc (package): 61354-115-02
ndc (package): 61354-115-01
ndc (product): 61354-115
ndc11 (package): 61354011501
ndc11 (package): 61354011502
spl id: 08a1e862-b55b-fb84-e063-6294a90a016a
spl set id: 08a1e862-b55a-fb84-e063-6294a90a016a

Reported adverse events (FAERS/openFDA)#

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