FDA.reportPublic FDA data

Cream

Product NDC
61354-115
11-digit product format
613540115
Labeler code
61354
Product ID
61354-115_08a1e862-b55b-fb84-e063-6294a90a016a
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Oxygen Development LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-26
Substance
ZINC OXIDE
Active strength
21.76 mg/100mg
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE21.76 mg/100mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
08a1e862-b55a-fb84-e063-6294a90a016aAvailable on FDA.report

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

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 34 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3CR Cool RosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Diord12905b6-97aa-429a-8800-23856fe31f062026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 0N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior43599d17-81f4-4c6e-b6bd-d1e700b668ee2026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 0.5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior116f09db-f859-40c5-8857-33503903ee762026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior480e5bf9-8e24-4335-a434-93255ceb640e2026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1.5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior7057feab-20fe-4547-8223-0816904bcfd62026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1CR Cool RosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior672a804d-ba8e-4c03-91fc-3edc0b12c6272026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3.5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb656394d-a410-4f8c-a632-815a349fb17e2026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 6.5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior4d47292f-35f2-4e9f-a9d8-2df57cbe92cf2026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 7N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior96258152-5255-4f04-9a35-c5a76b9c05202026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5df158da-3280-4ce6-a04c-3709993434002026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2.5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorbe60feb0-8c16-4ef6-a36f-423ed18e098c2026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior2d7678b4-b082-4911-80a2-c019eb5294142026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 9N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior00c9da7c-d4c7-49da-afa9-1fde93a815402026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior201acd8e-23c6-43fd-81dc-a814c3d8160b2026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 8N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb24806b1-d9da-4373-b072-6d9a262ea3652026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc981ae5e-e7e8-484b-b682-fb96d501e03b2026-05-06WarningsExact identifier
application number: M020
Poth Clear Gel Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPoth LLC1b0b6716-f4e1-4a3b-9f06-1c95f1f8a17a2026-05-06WarningsExact identifier
application number: M020
FORGE SKIN MINERAL TALLOW SUNSCREEN 30 SPFFORGE SKIN MINERAL TALLOW SUNSCREEN 30 SPFHorizons Ventures LLC5127ac89-3dff-5966-e063-6394a90a11db2026-05-06WarningsExact identifier
application number: M020
PREMIUM BEAUTY BALM BROAD SPECTRUM SPF 30OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDEHave & Be Co., Ltd.4a7e868d-6310-6ee4-e063-6394a90aebce2026-05-06WarningsExact identifier
application number: M020
Vivaiodays Sunscreen with TurmericZINC OXIDE5SENCO INC DBA VIVAIODAYS5129e680-f485-9c66-e063-6394a90a0e7e2026-05-06WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61354-115-0161354011501100 mg in 1 TUBE100 mgHistorical
61354-115-02613540115021 TUBE in 1 CARTON (61354-115-02) / 100 mg in 1 TUBE (61354-115-01) 1 tube2023-10-26NoNoCurrent