FDA.reportPublic FDA data

BEAUTY SHIELD BROAD SPECTRUM SUNSCREEN (Napoleon Perdis)

Product NDC
51386-291
11-digit product format
513860291
Labeler code
51386
Product ID
51386-291_40c00494-e120-f1f6-e063-6394a90aad33
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Napoleon PerdisCosmetic Pty Ltd
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-25
Substance
ZINC OXIDE
Active strength
132 mg/mL
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
BEAUTY SHIELD BROAD SPECTRUM SUNSCREEN (Napoleon Perdis)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE132 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
be64bb40-b1a9-2308-e053-2a95a90a69c8Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-06-19BEAUTY SHIELD BROAD SPECTRUM SUNSCREEN (Napoleon Perdis)
2023-06-19BEAUTY SHIELD BROAD SPECTRUM SUNSCREEN (Napoleon Perdis)
2023-01-30BEAUTY SHIELD BROAD SPECTRUM SUNSCREEN (Napoleon Perdis)
2023-01-30BEAUTY SHIELD BROAD SPECTRUM SUNSCREEN (Napoleon Perdis)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51386-291-01BEAUTY SHIELD BROAD SPECTRUM SUNSCREEN (Napoleon Perdis)50 mL in 1 TUBELOTION505
51386-291-02BEAUTY SHIELD BROAD SPECTRUM SUNSCREEN (Napoleon Perdis)1 in 1 CARTONLOTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51386-291BEAUTY SHIELD BROAD SPECTRUM SUNSCREEN (NAPOLEON PERDIS) (ZINC OXIDE) LOTION [NAPOLEON PERDISCOSMETIC PTY LTD]3Current NDC, Legacy NDC, 2 package rows20241004_be64bb40-b1a9-2308-e053-2a95a90a69c8.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 88 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHISEIDO BENEFIANCE WRINKLERESIST24 DAYAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION7d9c0f81-005f-4223-940e-a64143db52752026-01-06WarningsExact identifier
application number: M020
SHISEIDO FUTURE Solution LX INFINITE TREATMENT PRIMERTITANIUM DIOXIDE, OCTINOXATE, AND ENSULIZOLESHISEIDO AMERICAS CORPORATIONff088b0c-27c9-4ea8-bf94-6261378c71902026-01-06WarningsExact identifier
application number: M020
Drs. pharmacy sunscreen SPF 50 (physical filters)SUNSCREEN SPF 50OL PHARMA TECH LLC. (Drs. Pharmacy)31e976a2-0623-0dca-e063-6394a90a08da2026-01-06WarningsExact identifier
application number: M020
SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 115 Fair ShirakabaOCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION26151cf4-0fee-4a42-92fd-4d7b9cef83812026-01-06WarningsExact identifier
application number: M020
Drs. pharmacy sunscreen SPF 50 (physical filters)SUNSCREEN SPF 50OL PHARMA TECH LLC. (Drs. Pharmacy)315a5ca4-4536-d585-e063-6294a90a1c502026-01-06WarningsExact identifier
application number: M020
Drs. pharmacy sunscreen SPF 30 (Physical Filters)SUNSCREEN SPF 30OL PHARMA TECH LLC. (Drs. Pharmacy)315a5b1f-9dc2-a243-e063-6394a90a5e082026-01-06WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTORAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION51f759b7-8c49-41d4-aaa3-f901d599cac52026-01-06WarningsExact identifier
application number: M020
cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER ENRICHED n (Refill)AVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION463dc557-9743-4a38-969e-2c78fc10ee2a2026-01-06WarningsExact identifier
application number: M020
CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING nAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONESHISEIDO AMERICAS CORPORATION23bb4225-bfb5-47e2-80fe-733761ba40692026-01-06WarningsExact identifier
application number: M020
SHISEIDO WHITE LUCENT DAYAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONe881e637-e0f0-4c90-8343-2be6e74020b82026-01-06WarningsExact identifier
application number: M020
Hawaiian Tropic Lip Balm Sunscreen SPF 30AVOBENZONE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCc7b71be3-f906-bd09-e053-2995a90adc612026-01-06WarningsExact identifier
application number: M020
SHISEIDO BENEFIANCE WRINKLERESIST24 DAYAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONd308d578-c881-4c10-8c79-9e3cd58b694c2026-01-06WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC051b7413-8f1b-7135-e063-6294a90a93642026-01-06WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen Lip Balm SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE,Beiersdorf Inc47bc6776-1130-0162-e063-6294a90a2adc2026-01-06WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC088fa3cd-b9b8-d10b-e063-6394a90a7fd62026-01-06WarningsExact identifier
application number: M020
SPF 50 Florida Sun Defense Broad Spectrum SPF 50 Sunscreen Body OilHOMOSALATE, OCTISALATE, OCTOCRYLENENaples Soap Company, Inc.47c147a9-c4f4-ab82-e063-6394a90aaa5c2026-01-06WarningsExact identifier
application number: M020
PoutScreen Lip Treatment Love LetterAVOBENZONE, OCTINOXATE, OCTOCRYLENENAKED SUNDAYS PTY LTD47d22c6d-49fd-f97c-e063-6294a90a6ba12026-01-06WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands, LLC56ab90db-51bd-ffb3-e063-6294a90a852b2026-01-06WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands, LLC56ac28e7-41f1-bd4e-e063-6294a90a0e7b2026-01-06WarningsExact identifier
application number: M020
Moisturizing Antioxidant SPF 50OCTINOXATE, OCTISALATE, HOMOSALATE, OXYBENZONE, ZINC OXIDETopiderm, Inc.727c14d3-ad26-4e8b-91f6-b7a5f07e4e2f2026-01-05WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51386-291-015138602910150 mL in 1 TUBE50 mlHistorical
51386-291-02513860291021 TUBE in 1 CARTON (51386-291-02) / 50 mL in 1 TUBE (51386-291-01) 1 tube2021-03-250000-00-00NoNoCurrent