FDA.reportPublic FDA data

Baby Donna SHeer SPF Sunscreen Stick

Product NDC
69555-044
11-digit product format
695550044
Labeler code
69555
Product ID
69555-044_2b899f07-4c47-cd87-e063-6294a90a4090
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
STICK
Route
TOPICAL
Labeler
Stream2Sea, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-28
Substance
ZINC OXIDE
Active strength
19 g/100g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct69555-044UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69555-04469555-044-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
Baby Donna SHeer SPF Sunscreen Stick
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE19 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
a1b1cdeb-e5fe-4ba1-8bb0-3c7a97dd93feAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69555-044-01Baby Donna SHeer SPF Sunscreen Stick16 g in 1 CONTAINERSTICK162
69555-044-01Baby Donna SHeer SPF Sunscreen Stick1 in 1 BOXSTICK12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69555-044BABY DONNA SHEER SPF SUNSCREEN STICK (ZINC OXIDE) STICK [STREAM2SEA, LLC]2Current NDC, 2 package rows20250114_a1b1cdeb-e5fe-4ba1-8bb0-3c7a97dd93fe.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 141 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 47NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.c2ad2a5e-f8fe-41b3-8b0f-9981c337ec5c2025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 31NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.4206b607-5c26-4c9d-ade7-58c9740cdbe82025-12-09WarningsExact identifier
application number: M020
L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 MediumOCTOCRYLENE, ZINC OXIDEL'BRI Health & Beauty949a2796-717c-4820-ae09-2636e3dd6e3d2025-12-09WarningsExact identifier
application number: M020
L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 Medium DarkOCTOCRYLENE, ZINC OXIDEL'BRI Health & Beautyf9bbc6d3-eb50-4953-8dba-732094b4c7c42025-12-09WarningsExact identifier
application number: M020
Safe Sea SPF 50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONENIDARIA TECHNOLOGY LTD53df3126-1136-490a-b339-5876ce89499e2025-12-09WarningsExact identifier
application number: M020
Safe Sea SPF 50 kidsHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONENIDARIA TECHNOLOGY LTD3fa04557-2bc1-4eb4-aed8-eacc791896132025-12-09WarningsExact identifier
application number: M020
Safe Sea SPF 40OCTOCRYLENE, HOMOSALATE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANENIDARIA TECHNOLOGY LTDc900b88b-1de1-4df9-af84-d9001e1d47642025-12-09WarningsExact identifier
application number: M020
StriVectin ANTI-WRINKLE GLOWFECTOR SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEStriVectin Operating Company, Inc.ed357e76-54a1-66bd-e053-2a95a90a1e2a2025-12-09WarningsExact identifier
application number: M020
Non-tinted Physical Block SunscreenTITANIUM DIOXIDE, ZINC OXIDETucson Acne Clinic30dd2f6b-5dcc-b081-e063-6394a90ae5f12025-12-09WarningsExact identifier
application number: M020
Tinted Physical Block SunscreenTITANIUM DIOXIDE, ZINC OXIDETucson Acne Clinic30dc6e23-ecca-ed0b-e063-6294a90a79512025-12-09WarningsExact identifier
application number: M020
Tinted Physical Block SunscreenTITANIUM DIOXIDE, ZINC OXIDETucson Acne Clinic30ddc3d7-76df-3344-e063-6294a90a65ae2025-12-09WarningsExact identifier
application number: M020
Tinted Physical Block SunscreenTITANIUM DIOXIDE, ZINC OXIDETucson Acne Clinic30ddf80c-8496-0f47-e063-6394a90afc182025-12-09WarningsExact identifier
application number: M020
Lightly Tinted Mineral Block SunscreenZINC OXIDETucson Acne Clinic30dfa973-3217-1e18-e063-6294a90a8d412025-12-09WarningsExact identifier
application number: M020
Lightly Tinted Mineral Block SunscreenZINC OXIDETucson Acne Clinic30df0039-4dc1-7355-e063-6394a90ae8002025-12-09WarningsExact identifier
application number: M020
Advanced Lip GuardTITANIUM DIOXIDE, ZINC OXIDEADVANCED DERMATOLOGY32e66ff3-ae1a-4a2a-e063-6294a90a79632025-12-09Exact identifier
application number: M020
Skin Tone Defender 20% Zinc OxideZINC OXIDECali Skin Care LLC308c711d-4c3e-1208-e063-6394a90a9cc22025-12-09WarningsExact identifier
application number: M020
Advanced Light Perfecting SunscreenZINC OXIDEADVANCED DERMATOLOGY32d781ca-7993-9875-e063-6294a90a5c262025-12-09Exact identifier
application number: M020
Advanced Light Perfecting SunscreenZINC OXIDEAdvanced Dermatology32e6c080-6ce3-8d99-e063-6294a90ac1bc2025-12-09Exact identifier
application number: M020
StriVectin multi-action Super-C SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEStriVectin Operating Company, Inc.b299df12-fbdd-437b-9bfa-4846e361725a2025-12-09WarningsExact identifier
application number: M020
Original TintTITANIUM DIOXIDE, ZINC OXIDEL.S. MOORE LLC37f1e019-32c4-b733-e063-6394a90aca282025-12-09Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69555-044-01695550044011 CONTAINER in 1 BOX (69555-044-01) / 16 g in 1 CONTAINER1 container2023-03-28NoNoCurrent