FDA.reportPublic FDA data

OS-01 FACE SPF BS SPF 30 TINTED DEEP

Product NDC
84451-005
11-digit product format
844510005
Labeler code
84451
Product ID
84451-005_3581efdc-41fa-a450-e063-6294a90a4e56
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
ONESKIN INC.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-12
Substance
ZINC OXIDE
Active strength
17.5 g/100g
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
OS-01 FACE SPF BS SPF 30 TINTED DEEP
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE17.5 g/100g

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
3581f578-e19e-9ace-e063-6294a90acc34Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84451-005-01OS-01 FACE SPF BS SPF 30 TINTED DEEP40 g in 1 TUBECREAM401
84451-005-02OS-01 FACE SPF BS SPF 30 TINTED DEEP1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84451-005OS-01 FACE SPF BS SPF 30 TINTED DEEP (ZINC OXIDE) CREAM [ONESKIN INC.]1Current NDC, 2 package rows20250521_3581f578-e19e-9ace-e063-6294a90acc34.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 329 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr.C.Tuna Sun Body SPF50AVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENETan Alize Kozmetik ve Temizlik Urunleri Sanayi ve Ticaret Anonim Sirketi250d8b0c-729b-4a0d-b6b0-2c9fdbc661972023-11-05WarningsExact identifier
application number: M020
Farmasi BBAVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENETAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI042817f9-675e-056a-e063-6394a90a2d972023-11-05WarningsExact identifier
application number: M020
JACKET SPF 50ZINC OXIDE, OCTINOXATE, OCTISALATE, OCTISALATEBalshi MD Dermaceuticalsb82b8a46-8009-416e-8718-296a231069142023-11-05WarningsExact identifier
application number: M020
SEA STAR SPARKLE SPF 50 Glitter Sunscreen Cotton CandyHOMOSALATE, OCTOCRYLENE, OCTISALATE, ZINC OXIDEMJ Products Association, LLC6ccd648f-ec3b-4325-8d89-b5dd10c2fff72023-11-05WarningsExact identifier
application number: M020
SEA STAR SPARKLE SPF 50 Glitter Sunscreen Cotton CandyHOMOSALATE, OCTOCRYLENE, OCTISALATE, ZINC OXIDEMJ Products Association, LLC43c84cab-e35b-4808-bcc5-399573aef3b42023-11-05WarningsExact identifier
application number: M020
NO BS Moisturizer SPF20OCTINOXATE, OCTISALATE, AVOBENZONEProduct Management, LLC142f3610-85da-408d-8fa5-3773167ffc9f2023-11-05WarningsExact identifier
application number: M020
SEA STAR SPARKLE SPF 50 Glitter Sunscreen Coco LimeHOMOSALATE, OCTOCRYLENE, OCTISALATE, ZINC OXIDEMJ Products Association, LLC63b252c4-7d02-475b-97aa-57ef9c2e52ad2023-11-05WarningsExact identifier
application number: M020
SEA STAR SPARKLE SPF 50 Glitter Sunscreen Coco LimeHOMOSALATE, OCTOCRYLENE, OCTISALATE, ZINC OXIDEMJ Products Association, LLC533b6106-7f6f-49b9-9670-e2050bfcb9322023-11-05WarningsExact identifier
application number: M020
VERTRA Premium Suncare SPF 30TITANIUM DIOXIDE, ZINC OXIDEEai-Jr286, Inc.720ca725-24ca-4b59-b640-afa9832386922023-11-05WarningsExact identifier
application number: M020
BEACH GYPSY Glitter Sunscreen SPF 30OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEMJ Products Association, LLC1d224ecf-d356-424e-b181-ad8692f82b032023-11-05WarningsExact identifier
application number: M020
BEAST HYDRATING FACE SPF-20OCTOCRYLENE, OCTISALATE, AVOBENZONESmall Batch Beauty, LLC37941628-9f4f-474e-a8d9-080f4c6631122023-11-05WarningsExact identifier
application number: M020
NAELI Day Moisturizer SPF 30OCTISALATE, OCTOCRYLENE, AVOBENZONEAlli LLC9fe2f5c4-cf20-207e-e053-2a95a90ac54f2023-11-05WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1COCTISALATE, TITANIUM DIOXIDEParfums Christian Dior4c9ffd30-4799-475d-94cb-07ce3d5b36602023-11-04WarningsExact identifier
application number: M020
enfuselle BODY SUNSCREEN BROAD SPECTRUM SPF 30HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENEShaklee Corporationc57bfab7-f67c-435b-8703-e2051cfd097e2023-11-03WarningsExact identifier
application number: M020
Youth 2 Activating BB Cream SPF 30 Light MediumZINC OXIDE, TITANIUM DIOXIDEShaklee Corporatione51e38c9-cc9b-4af3-842d-41d0162f17ff2023-11-03WarningsExact identifier
application number: M020
Youth 4 Activating BB Cream SPF 30 DarkZINC OXIDE, TITANIUM DIOXIDEShaklee Corporation63f7f8bd-02f0-4a13-bb1e-298754b24fce2023-11-03WarningsExact identifier
application number: M020
Youth 1 Activating BB Cream SPF 30 LightZINC OXIDE, TITANIUM DIOXIDEShaklee Corporationc9e05055-48ea-405d-b1d4-50b263d0dbf92023-11-03WarningsExact identifier
application number: M020
CAPTURE DREAMSKIN FRESH and PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 020OCTINOXATE,TITANIUM DIOXIDE,ZINC OXIDEParfums Christian Diorfe03fc14-4132-4dab-b013-d490764be0d42023-11-03WarningsExact identifier
application number: M020
CAPTURE DREAMSKIN FRESH and PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 000OCTINOXATE,TITANIUM DIOXIDE,ZINC OXIDEParfums Christian Dior968cfae7-89b6-4ef3-ab60-1c675b90c1512023-11-03WarningsExact identifier
application number: M020
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 1NENSULIZOLE, OCTISALATEParfums Christian Diord2ca01ad-68b2-4312-a9d0-04d3e992bb132023-11-03WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84451-005-018445100050140 g in 1 TUBE40 gHistorical
84451-005-02844510005021 TUBE in 1 CARTON (84451-005-02) / 40 g in 1 TUBE (84451-005-01) 1 tube2025-05-12NoNoCurrent