FDA.reportPublic FDA data

DOCTOR BABOR SOLAR DEFENSE MINERAL SUNSCREEN BROAD SPECTRUM SPF 30

Product NDC
44924-902
Requested package NDC
44924-902-01
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 265 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MISSHA ALL AROUND VITA C SUNSCREENZINC OXIDE, HOMOSALATE, ETHYLHEXYL SALICYLATE, TITANIUM DIOXIDEAble C&C Co., Ltd.1a7ec673-328a-8924-e063-6294a90a2f3d2024-12-05WarningsExact identifier
application number: M020
(Re)Setting Refreshing Mist SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCd4d8f28d-cb00-298d-e053-2995a90a10eb2024-12-05WarningsExact identifier
application number: M020
KEYS SOULCARE DAILY MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc2ba71f81-54d0-4955-9bae-2b6e35c9c35f2024-12-05WarningsExact identifier
application number: M020
Cay Skin Isle Glow Body SPF 45AVOBENZONE, OCTISALATE, OCTOCRYLENECay Skin, Inc.db5f6bad-65ae-2b05-e053-2a95a90a85692024-12-05WarningsExact identifier
application number: M020
Cay Skin Isle Glow Face SPF 45AVOBENZONE, OCTISALATE, OCTOCRYLENECay Skin, Inc.d91bba06-fd9b-3eb5-e053-2995a90a61242024-12-05WarningsExact identifier
application number: M020
Whoa Glow broad spectrum spf 30 sunscreen Sheer Bronze shimmerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc65de9491-8804-4e3b-90a7-9b253e34b7d32024-12-05WarningsExact identifier
application number: M020
Whoa Glow broad spectrum spf 30 sunscreen Sheer Champagne shimmer sunlightAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc499e5352-fcc4-4434-96f2-4375816991c92024-12-05WarningsExact identifier
application number: M020
Cay Skin Isle Sheen Sunstick SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECay Skin, Inc.288c3aeb-01b2-ce39-e063-6394a90ad04a2024-12-05WarningsExact identifier
application number: M020
Cay Skin MoBay Mineral Sunscreen Drops SPF 30ZINC OXIDECay Skin, Inc.288d5456-98f3-a998-e063-6294a90a83662024-12-05WarningsExact identifier
application number: M020
Solar Moisturizer SPF 30OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENEAllure Labs, LLCef4d54bf-25f5-4261-9d3d-c42b0d8922752024-12-05WarningsExact identifier
application number: M020
Clear Clear Zinc Solar Protection SPF 30ZINC OXIDEAllure Labs, LLC79a3c8e2-c4f2-4c00-8e94-494654ae91a22024-12-05WarningsExact identifier
application number: M020
LAB SERIES DAY RESCUE DEFENSE BROAD SPECTRUM SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE, AND OXYBENZONEAramis Inc.8b206b6d-92e4-48bc-a40c-93ffdd6355352024-12-05WarningsExact identifier
application number: M020
Kids Broad Spectrum SPF 35ZINC OXIDEAllure Labs, LLCb72caf9b-46df-f30c-e053-2995a90a9b6d2024-12-05WarningsExact identifier
application number: M020
CBD Blue Light Defense SPF 30ZINC OXIDEAllure Labsb63b99af-2ddb-3535-e053-2a95a90a65d52024-12-05WarningsExact identifier
application number: M020
AHAVA CC SPF 30AVOBENZONE, ENSULIZOLE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEAHAVA - Dead Sea Laboratories Ltd2fa6249a-9614-455c-8e07-9b829f3b0c222024-12-04WarningsExact identifier
application number: M020
EGF FGF DNA UV SHIELDETHYLHEXYL METHOXYCINNAMATE, TITANIUM DIOXIDE, ETHYLHEXYL SALICYLATEDermaesthetics Inc.13e2630d-9915-4287-91fd-deb6721501312024-12-04WarningsExact identifier
application number: M020
SUNSCREEN 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.e98c3b64-edcb-16c7-e053-2a95a90a8a0e2024-12-04WarningsExact identifier
application number: M020
Sun ,Bug Handsfree 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.f8f29aec-935f-e828-e053-6394a90a570a2024-12-04WarningsExact identifier
application number: M020
sunscreen 01AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.e9e3ecc1-3f13-1d0e-e053-2a95a90ac7f82024-12-04WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB No 13ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.95846b5e-5b72-26bc-e053-2a95a90ae0f72024-12-04WarningsExact 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