FDA.reportPublic FDA data

DOCTOR BABOR SOLAR DEFENSE MINERAL SUNSCREEN BROAD SPECTRUM SPF 30

Product NDC
44924-902
11-digit product format
449240902
Labeler code
44924
Product ID
44924-902_291ec3bd-2575-c712-e063-6394a90aaede
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
BABOR Cosmetics America Corp
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-12
Substance
ZINC OXIDE
Active strength
182.2 mg/mL
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
DOCTOR BABOR SOLAR DEFENSE MINERAL SUNSCREEN BROAD SPECTRUM SPF 30
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE182.2 mg/mL

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
291ec801-ee15-06a4-e063-6294a90ab32bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44924-902-01DOCTOR BABOR SOLAR DEFENSE MINERAL SUNSCREEN BROAD SPECTRUM SPF 3030 mL in 1 BOTTLE, PUMPCREAM301
44924-902-01DOCTOR BABOR SOLAR DEFENSE MINERAL SUNSCREEN BROAD SPECTRUM SPF 301 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44924-902DOCTOR BABOR SOLAR DEFENSE MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 (ZINC OXIDE) CREAM [BABOR COSMETICS AMERICA CORP]1Current NDC, 2 package rows20241215_291ec801-ee15-06a4-e063-6294a90ab32b.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 223 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens SPF 50 Clear Complexion Face SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY311ae6d6-d466-3f1d-e063-6294a90ab3dd2025-03-24WarningsExact identifier
application number: M020
DOMINAS DARK SPOT TINTED SUNSCREENOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H CO., LTD.2b6140cf-7e34-1658-e063-6394a90a32712025-03-24WarningsExact identifier
application number: M020
CVS Health SPF 70 Ultra SheerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacy311de9db-941c-5af9-e063-6294a90a3a132025-03-24WarningsExact identifier
application number: M020
CVS Health SPF 70 Beach Guard ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacy311e6378-5afa-d7eb-e063-6394a90a77282025-03-24WarningsExact identifier
application number: M020
Naked Sundays Golden Glow Body Sunscreen SPF50 100mlNAKED SUNDAYS GOLDEN GLOW BODY SUNSCREEN SPF50 100MLNAKED SUNDAYS PTY LTDe182a39b-89b1-7756-e053-2a95a90ab6192025-03-23WarningsExact identifier
application number: M020
ANTIOXIDANT BODY SUNSCREEN CREME SPF50 BROAD SPECTRUMAVOBENZONE 30MG/G, HOMOSALATE 100MG/G, OCTOCRYLENE 100MG/G, OCTISALATE 50MG/G,NAKED SUNDAY PTY LTDeb7a84a8-3e25-9988-e053-2a95a90a58a92025-03-23WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Illuminating 40mL with Pink Algae SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD01273e8c-aef0-d800-e063-6294a90abd492025-03-23WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 40mL with wild Rosella SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD01221d57-9eec-7e77-e063-6394a90a60422025-03-23WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Blush 40mL SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD0ce809a1-45fb-9d4d-e063-6294a90a26a22025-03-23WarningsExact identifier
application number: M020
GLOW BODY MIST SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENAKED SUNDAYS PTY LTDcba78484-3c0b-413e-e053-2995a90aad862025-03-23WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID NATURAL SUNCREAMZINC OXIDEISNTREE Inc.2a86be75-c0f3-a8a1-e063-6294a90a04482025-03-23WarningsExact identifier
application number: M020
SPF50 SHEER GLOW BALM ESPRESSO MARTINI 9gZINC OXIDE 22.75%NAKED SUNDAY PTY LTDfbfc1e74-139e-8b0d-e053-6394a90a97c52025-03-22WarningsExact identifier
application number: M020
Naked Sundays PoutScreen Plumping Lip Treatment Caramel Latte 10mLLIP TREATMENTNAKED SUNDAYS PTY LTD2499e14a-c14f-ea13-e063-6394a90a62f52025-03-22WarningsExact identifier
application number: M020
Naked Sundays PoutScreen Plumping Lip Treatment Cotton Candy 10mLLIP TREATMENTNAKED SUNDAYS PTY LTD24a7bee2-3802-4786-e063-6294a90a6ab52025-03-22WarningsExact identifier
application number: M020
Naked Sundays PoutScreen Plumping Lip Treatment VANILLA CONFETTI 10mLLIP TREATMENTNAKED SUNDAYS PTY LTD24aa19c8-86d9-c691-e063-6394a90a691e2025-03-22WarningsExact identifier
application number: M020
Naked Sundays PoutScreen Plumping Lip Treatment Marshmallow 10mLLIP TREATMENTNAKED SUNDAYS PTY LTD24a98d3d-f830-9614-e063-6394a90aa7d12025-03-22WarningsExact identifier
application number: M020
SPF50 SHEER GLOW BALM CHAMPAGNE 9gZINC OXIDE 22.75%NAKED SUNDAY PTY LTDfbfb871b-460f-271a-e053-6394a90acad22025-03-22WarningsExact identifier
application number: M020
Naked Sundays Glow Balm Mineral Peptide Stick Broad Spectrum SPF50 Bronze 8gZINC OXIDENAKED SUNDAYS PTY LTD2f42d22a-983e-d304-e063-6294a90a37192025-03-22WarningsExact identifier
application number: M020
SPF50 SHEER GLOW BALM ROSE 9gZINC OXIDE 22.75%NAKED SUNDAY PTY LTDfbfbd0dd-8961-5fd0-e053-6294a90a5de42025-03-22WarningsExact identifier
application number: M020
Naked Sundays Face Body Clear Glow Sunstick SPF50 SHIMMER Broad Spectrum SPF50 19gAVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5% ,OCTOCRYLENE 8%NAKED SUNDAYS PTY LTD2f47a6c9-dd0a-da94-e063-6294a90a9a452025-03-22WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
44924-902-01449240902011 BOTTLE, PUMP in 1 CARTON (44924-902-01) / 30 mL in 1 BOTTLE, PUMP2024-12-12NoNoCurrent