FDA.reportPublic FDA data

ATOMY BB SUNSCREEN

Product NDC
52257-1430
11-digit product format
522571430
Labeler code
52257
Product ID
52257-1430_53421317-2f22-b017-e063-6294a90a41f2
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
ATOMY CO., LTD.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-01
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
8.22; 5.76 g/100mL; g/100mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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
ATOMY BB SUNSCREEN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE8.22 g/100mL
ZINC OXIDE5.76 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
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
b0cd27ee-4917-4800-bcdf-c6e14b28c1d1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52257-1430-12024-01-31C16284748780-11030e364-fa55-111a-e063-dadaa90a10e2b0cd27ee-4917-4800-bcdf-c6e14b28c1d1
52257-1430-12024-01-31C16284748780-11030e364-fa55-111a-e063-dadaa90a10e2b0cd27ee-4917-4800-bcdf-c6e14b28c1d1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52257-1430-1ATOMY BB SUNSCREEN40 mL in 1 CARTONCREAM403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52257-1430ATOMY BB SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [ATOMY CO., LTD.]3Current NDC, 1 package rows20240201_b0cd27ee-4917-4800-bcdf-c6e14b28c1d1.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
52257-1430-15225714300140 mL in 1 CARTON (52257-1430-1) 40 ml2023-10-01NoNoCurrent