FDA.reportPublic FDA data

Cream

Manufacturer
Oxygen Development LLC
Effective date
2023-02-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:53:43

Label at a glance#

ProductCream
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

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

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply: after 80 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours. Sun protection measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the su...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 24%

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 cancer and early skin caused by the sun.

Warnings

WARNINGS SECTION

For external use only. Do not use on damaged or broken skin.

When using

OTC - WHEN USING SECTION

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

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 a Poison Control center right away

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Reapply: after 80 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours. Sun protection measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am - 2 pm. Wear long-sleeved shirt, pants, hat, and sunglasses. Children under 6 months: ask a doctor

Inactive ingredient

INACTIVE INGREDIENT SECTION

Water/Aqua, C15-19 Alkane, Glycerin, Polyglyceryl-3 Polyricinoleate, Ethyl Macadamiate, Caprylic/Capric Triglyceride, Styrene/Acrylates Copolymer, Stearyl/Octyldodecyl Citrate Crosspolymer, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Propanediol, Polyhydroxystearic Acid, Triethoxycaprylylsilane, 1,2-Hexanediol, Hydroxyacetophenone, Magnesium Sulfate, Sodium Chloride, Caprylhydroxamic Acid, Tocopheryl Acetate, Sodium Hyaluronate, Tocopherol, Malic Acid

Other information

OTHER SAFETY INFORMATION

Protect the product in this container from excessive heat and direct sun. May stain some fabrics. You may report a serious adverse event to the phone number provided below.

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61354-089-01_aw61354-089-01_aw

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61354-089-012025-01-30C16284748780-12cef2736-adb3-d83d-e063-dadaa90ab31fMUSTELA MINERAL SUNSCREEN FACE+BODY FAMILY SIZE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61354-089-01Cream1 mg in 1 BOTTLE, PUMPCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61354-089CREAM (ZINC OXIDE) CREAM [OXYGEN DEVELOPMENT LLC]11 package rows20230203_f3bb0b9d-baaf-4770-e053-2995a90a9571.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61354-08961354-089-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
1,2-HEXANEDIOLTR046Y3K1GIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
MAGNESIUM SULFATE, UNSPECIFIEDDE08037SABIACT
WATER059QF0KO0RIACT
STYRENE44LJ2U959VIACT
PROPANEDIOL5965N8W85TIACT
SODIUM CHLORIDE451W47IQ8XIACT
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMERPN88NW0KPKIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE25G622K2RAIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ETHYL MACADAMIATEANA2NCS6V1IACT
C15-19 ALKANECI87N1IM01IACT
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
f3bb0b9d-bab0-4770-e053-2995a90a9571f3bb0b9d-baaf-4770-e053-2995a90a95712023-02-02WarningsExact identifier
spl id: f3bb0b9d-bab0-4770-e053-2995a90a9571
spl set id: f3bb0b9d-baaf-4770-e053-2995a90a9571

Reported adverse events (FAERS/openFDA)#

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