FDA.reportPublic FDA data

NUDESCREEN LIP PRIMER SPF 30 - NATURAL TINT

Product NDC
54111-166
11-digit product format
541110166
Labeler code
54111
Product ID
54111-166_6c1235b2-ee13-436c-a6fe-05b40bdc8d99
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
LIPSTICK
Route
TOPICAL
Labeler
Bentley Laboratories, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-02-12
Substance
ZINC OXIDE
Active strength
15 g/100mL
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

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
NUDESCREEN LIP PRIMER SPF 30 - NATURAL TINT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE15 g/100mL

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
6edd51e5-1c42-4e66-b5ca-abfea2dad8f8Available 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
54111-166-50NUDESCREEN LIP PRIMER SPF 30 - NATURAL TINT10 mL in 1 TUBELIPSTICK102
54111-166-50NUDESCREEN LIP PRIMER SPF 30 - NATURAL TINT1 in 1 CARTONLIPSTICK12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54111-166NUDESCREEN LIP PRIMER SPF 30 - NATURAL TINT (ZINC OXIDE) LIPSTICK [BENTLEY LABORATORIES, LLC]2Current NDC, 2 package rows20241228_6edd51e5-1c42-4e66-b5ca-abfea2dad8f8.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 174 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Defense Daily Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEOffspring Beauty Co.2a462e60-6353-f791-e063-6294a90a62e32025-10-23WarningsExact identifier
application number: M020
Skin Solution Multi-Serum Skin Tint SPF 40ZINC OXIDEOffspring Beauty Co.2d598f5d-d23f-6d54-e063-6294a90a778d2025-10-23WarningsExact identifier
application number: M020
AussieZinc Mineral Sunscreen Vegan and Organic KidsZINC OXIDE SUNSCREENVEGANIC SKN LIMITED36c7a1be-87e5-1f87-e063-6394a90ad8762025-10-23WarningsExact identifier
application number: M020
Aussiezinc Mineral Sunscreen SPF50 BabyZINC OXIDEVeganic SKN Limited16cc5178-e4c7-38eb-e063-6294a90a66de2025-10-23WarningsExact identifier
application number: M020
AussieZinc Mineral Sunscreen Vegan and Organic EverydayZINC OXIDE SUNSCREENVEGANIC SKN LIMITED36c9e96f-0299-095b-e063-6394a90a411d2025-10-23WarningsExact identifier
application number: M020
AussieZinc Mineral Sunscreen Vegan and Organic Anti-Aging - Light TintZINC OXIDE SUNSCREENVEGANIC SKN LIMITED36c9f293-58c8-1a6f-e063-6394a90adc1f2025-10-23WarningsExact identifier
application number: M020
AussieZinc Mineral Sunscreen Vegan and Organic Hydrate and Nourish - Medium TintZINC OXIDE SUNSCREENVEGANIC SKN LIMITED36ca1103-b9bf-2573-e063-6394a90acdc52025-10-23WarningsExact identifier
application number: M020
AussieZinc Mineral Sunscreen Vegan and Organic Extra SensitiveZINC OXIDE SUNSCREENVEGANIC SKN LIMITED36ca5334-fd41-297f-e063-6394a90ac72e2025-10-23WarningsExact identifier
application number: M020
Mineral Sun DropsZINC OXIDESynchronicity Spa, Inc. DBA Suntegrityd8acda81-4430-42f8-be56-d28bb010e6302025-10-22WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 LatteOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASc34c1486-fa6c-485f-80b3-98e397b3dddb2025-10-22WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Cool VanillaOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS74c078ec-a371-4406-8d5e-a0baada3a1a62025-10-22WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 SandalwoodOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS2765f345-eab2-4878-b1f1-f8e2430834762025-10-22WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 ToffeeOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASd1181543-07ab-4a51-8b55-afc1a98293f62025-10-22WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Warm BeigeOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASc7be3a7e-f031-4ec0-b9dc-41c025cd00662025-10-22WarningsExact identifier
application number: M020
PowderTITANIUM DIOXIDEOxygen Development LLC41c0c262-21c3-b8e6-e063-6394a90a7c9c2025-10-22WarningsExact identifier
application number: M020
PHOTO FINISH INVISIBLE SPF 45 BROAD SPECTRUM SPF 45 PRIMERAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENESMASHBOX BEAUTY COSMETICS, INC41c4e135-c6df-82d4-e063-6294a90a0ad32025-10-22WarningsExact identifier
application number: M020
Miffy Sunny Defense SPF StickHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONERBGROUP Co., Ltd24802b17-c0ba-1075-e063-6394a90addd52025-10-21WarningsExact identifier
application number: M020
Sunny Defense SPF StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERBGROUP Co., Ltd18632155-5feb-5759-e063-6294a90ab88c2025-10-21WarningsExact identifier
application number: M020
Paul Frank Sunny Defense SPF StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERBGROUP Co., Ltd26345203-3393-60ba-e063-6394a90a7e922025-10-21WarningsExact identifier
application number: M020
Keith Haring Tone Blur Essence SunscreenHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONERBGROUP Co., Ltd1d578196-c785-9914-e063-6394a90a05332025-10-21WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54111-166-50541110166501 TUBE in 1 CARTON (54111-166-50) / 10 mL in 1 TUBE1 tube2023-02-12NoNoCurrent