FDA.reportPublic FDA data

NUDESCREEN BLUSH TINT SPF 30 - STRAWBERRY SUNBURST

Product NDC
54111-178
11-digit product format
541110178
Labeler code
54111
Product ID
54111-178_ab709d00-775a-4ed5-8a3f-106618dc7728
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE SUNSCREEN
Dosage form
LOTION
Route
TOPICAL
Labeler
Bentley Laboratories, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-27
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 BLUSH TINT SPF 30 - STRAWBERRY SUNBURST
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
4785585e-b623-4125-9867-8097694c7b58Available 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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54111-178-01NUDESCREEN BLUSH TINT SPF 30 - STRAWBERRY SUNBURST1 in 1 CARTONLOTION12
54111-178-01NUDESCREEN BLUSH TINT SPF 30 - STRAWBERRY SUNBURST15 mL in 1 TUBELOTION152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54111-178NUDESCREEN BLUSH TINT SPF 30 - STRAWBERRY SUNBURST (ZINC OXIDE SUNSCREEN) LOTION [BENTLEY LABORATORIES, LLC]2Current NDC, 2 package rows20231230_4785585e-b623-4125-9867-8097694c7b58.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 189 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 FUCHSIA CREAMYOCTINOXATE, ZINC OXIDEBEL STAR S Aea39a1c0-6b12-77ba-e053-2995a90a73142025-08-21WarningsExact identifier
application number: M020
Neutrogena Clear Face Breakout Free Oil Free Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCcd211d06-b91e-44b1-99fe-fa0794f102212025-08-21WarningsExact identifier
application number: M020
Sun Bum Sunscreen Lip Balm Broad Spectrum SPF 30 KiwiAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3cd51497-693e-bf79-e063-6394a90a5e482025-08-21WarningsExact identifier
application number: M020
LBEL SOLUTIONS PRO-NUDE SKIN ULTRA-LIGHT SERUM FOUNDATION WITH NIACINAMIDE SPF 20 CHAMPAGNE 170NOCTINOXATE, ZINC OXIDEBEL STAR S.A.2f769ed5-0176-8c80-e063-6394a90a92c62025-08-21WarningsExact identifier
application number: M020
Sun Bum 30 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC21caf385-f11b-146a-e063-6294a90aa8512025-08-21WarningsExact identifier
application number: M020
Sun Bum 50 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC21cb8652-c6d0-0a77-e063-6294a90a6e1e2025-08-21WarningsExact identifier
application number: M020
Sun Bum Signature High Performance Mineral Sunscreen Face Stick 30ZINC OXIDESun Bum, LLC3ce81478-196e-d87b-e063-6294a90afd582025-08-21WarningsExact identifier
application number: M020
Premium Moisturizing Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC33164cea-e31e-9fcc-e063-6294a90a307e2025-08-21WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 5ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3ceb3368-439c-9f6c-e063-6294a90a98ba2025-08-21WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 2ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3cc8b151-c07d-7473-e063-6294a90a1cc72025-08-20WarningsExact identifier
application number: M020
Olay Complete Hydrating with Sunscreen Broad Spectrum SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company3ccd2703-c410-74b7-e063-6294a90a7f882025-08-20WarningsExact identifier
application number: M020
SEYEZINC OXIDE AND TITANIUM DIOXIDE CREAMGuangzhou Seye Biomedical Technology Co., Ltd.3cce91b1-311b-4c95-e063-6294a90a2d7a2025-08-20WarningsExact identifier
application number: M020
Sun Bum Day Tripper - SPF 30 Moisturizing Sunscreen 3 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3ccfb90a-5976-4b38-e063-6294a90a123a2025-08-20WarningsExact identifier
application number: M020
Sun Bum Day Tripper - SPF 30 Sunscreen Lip Balm (Coconut) 0.15 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3cd3ce69-becc-41b7-e063-6394a90a27822025-08-20WarningsExact identifier
application number: M020
Lip Therapy Soothe and Protect Lip Treatment Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEObagi Cosmeceuticals LLC4838679b-f510-440b-8670-a10c05ebed9b2025-08-19WarningsExact identifier
application number: M020
Sun Bum Signature High Performance Mineral Sunscreen Broad Spectrum SPF 50 NewZINC OXIDESun Bum, LLC3b8e1d73-b023-cfbd-e063-6294a90ae29d2025-08-19WarningsExact identifier
application number: M020
Olay Total Effects Moisturizer with Sunscreen Broad Spectrum SPF 15 Fragrance-FreeAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company8de31db2-46cf-7178-e053-2995a90a50242025-08-19WarningsExact identifier
application number: M020
Lip Balm - Variety Pack (Target) - Banana (4)AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3cbcae23-9b38-edaa-e063-6294a90a2e8f2025-08-19WarningsExact identifier
application number: M020
Sun Bum Signature High Performance Mineral Sunscreen Lip Balm 30ZINC OXIDESun Bum, LLC3cbeb4ce-6d7c-387c-e063-6394a90af7902025-08-19WarningsExact identifier
application number: M020
Olay Total Effects Moisturizer Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEThe Procter & Gamble Manufacturing Company8de52cb2-b4d2-1e0d-e053-2995a90a5aca2025-08-19WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54111-178-01541110178011 TUBE in 1 CARTON (54111-178-01) / 15 mL in 1 TUBE1 tube2023-12-27NoNoCurrent