FDA.reportPublic FDA data

flawless photo finish

Product NDC
85575-208
Requested package NDC
85575-208-50
11-digit product format
855750208
Labeler code
85575
Product ID
85575-208_45b4b32f-e8cd-ee25-e063-6294a90a6a4f
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
NEXTEX CORPORATION
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-22
Substance
ZINC OXIDE
Active strength
160 mg/g
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
flawless photo finish
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE160 mg/g

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
35bb0ac4-6abd-ca75-e063-6394a90a26cdAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85575-208-50flawless photo finish50 g in 1 BOTTLE, PUMPCREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85575-208FLAWLESS PHOTO FINISH (ZINC OXIDE) CREAM [NEXTEX CORPORATION]1Current NDC, 1 package rows20250523_35bb0ac4-6abd-ca75-e063-6394a90a26cd.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 115 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c0400b-8ad9-654b-e063-6294a90ad0402025-12-16Exact identifier
application number: M020
Non Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c00301-ee41-333c-e063-6294a90a61d52025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c078fa-05f9-ad80-e063-6394a90af3bb2025-12-16Exact identifier
application number: M020
20Percent Zinc Oxide Non TintedZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c108f6-a928-0a54-e063-6394a90ae6862025-12-16Exact identifier
application number: M020
20Percent Zinc Oxide Non TintedZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c0ccca-c993-181e-e063-6294a90a7ae62025-12-16Exact identifier
application number: M020
Non Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c0a55d-16d3-086a-e063-6394a90a30cf2025-12-16Exact identifier
application number: M020
Eucerin Radiant ToneAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inc2611e0cb-d56d-6ea1-e063-6294a90a745b2025-12-16WarningsExact identifier
application number: M020
Really Great Lip ShieldTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c1341d-fbf5-56a5-e063-6294a90aa0452025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenZINC OXIDEKLOE SALON LLC36c23c07-2011-3ddb-e063-6294a90a76e92025-12-16Exact identifier
application number: M020
Tinted Mineral Sun DefenseTITANIUM DIOXIDE, ZINC OXIDEHelen's Haven36c465ea-979b-9474-e063-6394a90ab3f82025-12-16Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEHelen's Haven36c4a27b-96e9-4f30-e063-6294a90a56552025-12-16Exact identifier
application number: M020
Mineral Sunscreen Non TintedTITANIUM DIOXIDE, ZINC OXIDESAN JOSE MEDICAL SPA37ef19e5-1775-a8d5-e063-6394a90acaef2025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEBABYFACE LLC36d69eb5-59b4-14a0-e063-6394a90a0a492025-12-16Exact identifier
application number: M020
Non Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBABYFACE LLC36d6141c-6967-d779-e063-6294a90af0a72025-12-16Exact identifier
application number: M020
Replenishing Daily SunscreenZINC OXIDEBABYFACE LLC36d773d7-349d-68c1-e063-6394a90aff1e2025-12-16Exact identifier
application number: M020
TiZO Tinted Moisturizing Serum - LightZINC OXIDEFallien Cosmeceuticals, Ltd.2d44158a-44b3-5a3d-e063-6294a90a1f162025-12-16WarningsExact identifier
application number: M020
TiZO Tinted Moisturizing Serum - Light-MediumZINC OXIDEFallien Cosmeceuticals, Ltd.2d53071f-0275-d00c-e063-6294a90afcca2025-12-16WarningsExact identifier
application number: M020
TiZO Tinted Moisturizing Serum - MediumZINC OXIDEFallien Cosmeceuticals, Ltd.2d550967-25af-3e7a-e063-6394a90a2c792025-12-16WarningsExact identifier
application number: M020
TiZO Tinted Moisturizing Serum - Medium-DeepZINC OXIDEFallien Cosmeceuticals, Ltd.2d57790c-22cf-08aa-e063-6394a90aeac02025-12-16WarningsExact identifier
application number: M020
TiZO Tinted Moisturizing Serum - DeepZINC OXIDEFallien Cosmeceuticals, Ltd.2d5813e8-a219-db90-e063-6294a90a6ca72025-12-16WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85575-208-508557502085050 g in 1 BOTTLE, PUMP (85575-208-50) 50 g2025-04-22NoNoCurrent