FDA.reportPublic FDA data

Sunscreen

Manufacturer
Oxygen development
Effective date
2023-02-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:36:55

Label at a glance#

ProductSunscreen
Active ingredientZINC OXIDE
Label structure14 sections

Indications and uses

Helps to prevent the 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 to exposed areas 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 this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: Limi...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 24%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps to prevent the 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.

When Using

OTC - WHEN USING SECTION

When using this product keep out of the 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 a Poison Control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally to exposed areas 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 this 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, expecially from 10 a.m. - 2 p.m.wear long-sleeved shirt, pants, hat and sunglasses children under 6 months: ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

WATER, 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 this product from excessive heat and direct sun. May stain some fabrics. You may report a serious adverse event to the phone number or address provided below.

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-422-2987 Monday-Friday 9:00am-5:00pm EST

Primary Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61354-090-0161354-090-01

Primary Package 500ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61354-070-02_AW front61354-070-02_AW front61354-070-02_AW Back61354-070-02_AW Back500ml, 61354-070-02

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61354-090-012025-01-30C16284748780-1f386c649-e314-0266-e053-dadaa90a7c1aMUSTELA MINERAL SUNSCREEN FACE+BODY SPF50
61354-090-022025-01-30C16284748780-1f386c649-e314-0266-e053-dadaa90a7c1aMUSTELA MINERAL SUNSCREEN FACE+BODY SPF50
61354-090-012023-02-10C16284748780-1f386c649-e314-0266-e053-dadaa90a7c1aMUSTELA MINERAL SUNSCREEN FACE+BODY SPF50
61354-090-022023-02-10C16284748780-1f386c649-e314-0266-e053-dadaa90a7c1aMUSTELA MINERAL SUNSCREEN FACE+BODY SPF50
61354-090-012023-01-30C16284748780-1f386c649-e314-0266-e053-dadaa90a7c1aMUSTELA MINERAL SUNSCREEN FACE+BODY SPF50
61354-090-022023-01-30C16284748780-1f386c649-e314-0266-e053-dadaa90a7c1aMUSTELA MINERAL SUNSCREEN FACE+BODY SPF50

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61354-090SUNSCREEN (ZINC OXIDE) CREAM [OXYGEN DEVELOPMENT]2Legacy NDC20230211_bbeffa0a-2bc9-fea4-e053-2a95a90ac511.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
61354-09061354-090-01, 61354-090-02

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
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMERV5RS026Q0HIACT
SODIUM CHLORIDE451W47IQ8XIACT
GLYCERINPDC6A3C0OXIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
MAGNESIUM SULFATE, UNSPECIFIEDDE08037SABIACT
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDEFJ1H6M2JG9IACT
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMERPN88NW0KPKIACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE25G622K2RAIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
C15-19 ALKANECI87N1IM01IACT
POLYGLYCERYL-3 RICINOLEATEMZQ63P0N0WIACT
ETHYL MACADAMIATEANA2NCS6V1IACT
PROPANEDIOL5965N8W85TIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT

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
f45d8012-5c87-5d96-e053-2995a90a74b6bbeffa0a-2bc9-fea4-e053-2a95a90ac5112023-02-10WarningsExact identifier
spl id: f45d8012-5c87-5d96-e053-2995a90a74b6
spl set id: bbeffa0a-2bc9-fea4-e053-2a95a90ac511

Reported adverse events (FAERS/openFDA)#

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