FDA.reportPublic FDA data

Prime Protection Sunscreen, tinted

Product NDC
85641-203
11-digit product format
856410203
Labeler code
85641
Product ID
85641-203_45c73b28-999c-0a5c-e063-6394a90ab90a
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
KRISTI REDD ESTHETICS
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-21
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
80; 38 mg/g; mg/g
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
Prime Protection Sunscreen, tinted
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE80 mg/g
ZINC OXIDE38 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
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
3660af9e-d60f-c33e-e063-6394a90a3a05Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85641-203-15Prime Protection Sunscreen, tinted1.5 g in 1 PACKETCREAM1.52
85641-203-50Prime Protection Sunscreen, tinted53 g in 1 BOTTLE, PUMPCREAM532

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 243 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REVLON AGE DEFYING FIRMING LIFTING MAKEUP SPF 15OCTINOXATE, TITANIUM DIOXIDE MAKE-UPRevlon Consumer Products Corpd9209277-469d-48f4-bf64-f39a70c195962024-12-31WarningsExact identifier
application number: M020
Almay Smart Shade Skintone Matching Makeup LightTITANIUM DIOXIDE ZINC OXIDEAlmay, Inc.2a987b85-efdb-eb95-e063-6394a90aef812024-12-31WarningsExact identifier
application number: M020
ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20 LightTITANIUM DIOXIDE, ZINC OXIDEAlmay, Inc.2a984dd9-7293-77f0-e063-6294a90a8f1e2024-12-31WarningsExact identifier
application number: M020
Vichy Laboratoires Capital Soleil 50 Daily AntiAging Face Sunscreen Broad Spectrum SPF 50 Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc097fc15e-ea17-47b2-9581-19c5e11592f62024-12-30WarningsExact identifier
application number: M020
HERBAL UV DEFENSE SPF40HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENECOSMAX USA, CORPORATION2a76fd94-2f1f-e6d8-e063-6294a90a287c2024-12-30WarningsExact identifier
application number: M020
Almay Healthy Biome MakeupHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEAlmayab20969a-8640-307d-e053-2a95a90a004d2024-12-30WarningsExact identifier
application number: M020
EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUSOCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLEExelencia importers Corp.2a845e4c-86e7-1799-e063-6294a90a9b2b2024-12-30WarningsExact identifier
application number: M020
American Crew All In One Face Balm Broad Spectrum SPF 15OCTISALATE,HOMOSALATE,AVOBENZONE,OCTOCRYLENERevlon Consumer Products Corp012be422-1b4c-443c-9484-02efc744296d2024-12-30WarningsExact identifier
application number: M020
Advanced Ceramide Lift and Firm Day Cream Broad Spectrum Sunscreen SPF 15OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATEREVLON2a857553-5ad0-a0e2-e063-6294a90af4352024-12-30WarningsExact identifier
application number: M020
SkinCeuticals Sheer Physical UV Defense Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc2035ab03-80b4-49f4-b379-eb8bc42c9cee2024-12-30WarningsExact identifier
application number: M020
PRISMA PROTECT SPF30HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEDermalogica, LLC.713bad2e-bf32-4cd5-9630-b8d88d4376862024-12-30WarningsExact identifier
application number: M020
Protection 50 SportHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEDermalogica, LLC.e9ace96a-7717-4f5a-8e1b-1f56f74985992024-12-30WarningsExact identifier
application number: M020
SkinCeuticals Physical Matte UV Defense Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Incb137b3d0-212b-440a-b158-62ace4b4eff32024-12-30WarningsExact identifier
application number: M020
SkinCeuticals Physical UV Defense Broad Spectrum SPF 30 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc3a6db7d3-6c59-4633-a97e-1c03127246d32024-12-30WarningsExact identifier
application number: M020
Dermablend Professional Leg and Body Makeup Broad Spectrum SPF 25 SunscreenOCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incdf62e1c2-ce72-4ded-8985-156dce9ff41d2024-12-28WarningsExact identifier
application number: M020
LOreal Paris Revitalift Derm Intensives Invisible UV Fluid Broad Spectrum SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Inc02dddfc5-61e6-433b-8d6d-a17bf3fc8ed62024-12-28WarningsExact identifier
application number: M020
Vichy Laboratoires Aqualia Thermal UV Defense Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENECosmetique Active Production229eef79-39ae-4395-8100-64d1ece960d22024-12-28WarningsExact identifier
application number: M020
COOLA Mineral Sun Silk Creme Sunscreen SPF 30ZINC OXIDECOOLA LLCbb9dd9a9-ec01-4e94-9172-3a72e68a417a2024-12-27WarningsExact identifier
application number: M020
Bare Republic Mineral SPF 50ZINC OXIDECOOLA LLC6a0db9da-ee45-4ab7-80de-4bf189efe75f2024-12-27WarningsExact identifier
application number: M020
COOLA CLASSIC BODY SUNSCREEN Guava Mango Broad Spectrum SPF 50AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENECOOLA LLC9a397a2c-4734-4dae-93dd-15c68e6c297d2024-12-27WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85641-203-15856410203151.5 g in 1 PACKET (85641-203-15) 1.5 g2021-04-21YesNoCurrent
85641-203-508564102035053 g in 1 BOTTLE, PUMP (85641-203-50) 53 g2021-04-21NoNoCurrent