Home NDC 85331-203 Tinted Sunscreen
Product NDC 85331-203
11-digit product format 853310203
Labeler code 85331
Product ID 85331-203_45af23fa-cc5a-1a7e-e063-6394a90acf71
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Scottsdale Skin Boutique and Dermatology Pllc
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-07-20
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 Tinted Sunscreen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 80 mg/g ZINC OXIDE 38 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15FIX9V2JP Internal UNII lookup SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85331-203-15 Tinted Sunscreen 15 g in 1 PACKET CREAM 15 2 85331-203-50 Tinted Sunscreen 53 g in 1 BOTTLE, PUMP CREAM 53 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85331-203 TINTED SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SCOTTSDALE SKIN BOUTIQUE AND DERMATOLOGY PLLC] 1 Current NDC, 1 package rows 20250510_34a52011-b781-75cf-e063-6394a90ae0f4.zip 85331-203 TINTED SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SCOTTSDALE SKIN BOUTIQUE AND DERMATOLOGY PLLC] 1 Current NDC, 1 package rows 20250510_34a632f5-4458-e335-e063-6394a90a9bcb.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 330 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 2N ENSULIZOLE, OCTISALATE Parfums Christian Dior c790b9e4-6925-4796-9945-1c5484116a23 2023-11-03 Warnings Exact identifier application number: M020 CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 2W ENSULIZOLE, OCTISALATE Parfums Christian Dior f551db8d-7447-41b9-9249-5ee8f76be98a 2023-11-03 Warnings Exact identifier application number: M020 CAPTURE DREAMSKIN FRESH and PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 010 OCTINOXATE,TITANIUM DIOXIDE,ZINC OXIDE Parfums Christian Dior 775f4009-9fc2-475b-a141-b4b5e5542180 2023-11-03 Warnings Exact identifier application number: M020 CAPTURE DREAMSKIN FRESH and PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 030 OCTINOXATE,TITANIUM DIOXIDE,ZINC OXIDE Parfums Christian Dior 189f8767-f463-4c83-8a38-975ce8672b2a 2023-11-03 Warnings Exact identifier application number: M020 CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 1,5N ENSULIZOLE, OCTISALATE Parfums Christian Dior d9c6e0e0-f88e-48ba-94db-0cb198f8dbbe 2023-11-03 Warnings Exact identifier application number: M020 CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 3N ENSULIZOLE, OCTISALATE Parfums Christian Dior a1e5e9cf-3f59-4e1d-98d6-f17ed1ad8e51 2023-11-03 Warnings Exact identifier application number: M020 CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 2CR ENSULIZOLE, OCTISALATE Parfums Christian Dior 2345d277-3d46-4dfc-9c5d-db7887165ea6 2023-11-03 Warnings Exact identifier application number: M020 CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 5N ENSULIZOLE, OCTISALATE Parfums Christian Dior cfd207af-d650-4333-a79a-c8f4878e8f9a 2023-11-03 Warnings Exact identifier application number: M020 CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 7N ENSULIZOLE, OCTISALATE Parfums Christian Dior 5f5e61e3-ea93-401b-b55c-1eb0a711e738 2023-11-03 Warnings Exact identifier application number: M020 FOREVER SKIN VEIL Extreme Wear and Moisturizing Primer Correction, Protection, Illumination With Sunscreen Floral Extract-Enriched Broad Spectrum SPF20 OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior c59b4ece-0534-4072-afe8-2142a43c6bb2 2023-11-03 Warnings Exact identifier application number: M020 CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 4N ENSULIZOLE, OCTISALATE Parfums Christian Dior cfeb19b9-6597-4bd7-a635-d4024e291c5c 2023-11-03 Warnings Exact identifier application number: M020 CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 6N ENSULIZOLE, OCTISALATE Parfums Christian Dior c044849f-94ab-4d91-aac5-e3e9631bc8b1 2023-11-03 Warnings Exact identifier application number: M020 CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 030 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE Parfums Christian Dior cdc2a156-5ccd-4d40-98af-c529f0911a9e 2023-11-03 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h Wear Radiant Perfection Skin Caring Foundation With Sunscreen BROAD SPECTRUM SPF 35 Lasting Hydration 2WP OCTINOXATE, TITANIUM DIOXIDE PARFUMS CHRISTIAN DIOR 6ee0284e-739d-4aad-9352-9ea9c106efa4 2023-11-03 Warnings Exact identifier application number: M020 Broad Spectrum SPF 15 Coconut Lip Balm ZINC OXIDE Raining Rose, Inc. 2a03abc4-824b-438d-acc5-469853057679 2023-11-03 Warnings Exact identifier application number: M020 BEAUTY BEFORE AGE AHAVA UPLIFT DAY broad spectrum SPF 20 HOMOSALATE, OCTISALATE, AND AVOBENZONE AHAVA Dead Sea Laboratories Ltd bf872bbe-a2d1-4188-b331-e62e339b13e7 2023-11-03 Warnings Exact identifier application number: M020 All Good Broad Spectrum SPF 15 Spearmint Lip Balm BROAD SPECTRUM SPF 15 SPEARMINT LIP BALM Raining Rose, Inc. 77370d4e-6888-4cb7-b6b9-1011a71dbf7a 2023-11-03 Warnings Exact identifier application number: M020 365 Everyday Value SPORT LOTION MINERAL SUNSCREEN SPF 30 Whole Foods Market, Inc. 8f15b988-c009-4ca7-bb46-c0fb0aa62643 2023-11-03 Warnings Exact identifier application number: M020 365 Everyday Value SPORT LOTION MINERAL SUNSCREEN SPF 30 Whole Foods Market, Inc. 706ed90d-fd98-44bf-99b8-f8c12eec6857 2023-11-03 Warnings Exact identifier application number: M020 THE SOF FLUID LONG WEAR FOUNDATION BROAD SPECTRUM SPF 20 OCTINOXATE AND TITANIUM DIOXIDE MAX HUBER RESEARCH LAB INC 97787725-9175-46a7-8e3a-af5d06e21d7f 2023-10-30 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85331-203-15 85331020315 15 g in 1 PACKET (85331-203-15) 15 g 2022-07-28 Yes No Current 85331-203-50 85331020350 53 g in 1 BOTTLE, PUMP (85331-203-50) 53 g 2022-07-20 No No Current