FDA.reportPublic FDA data

Tinted Mineral Sunscreen

Product NDC
85318-203
11-digit product format
853180203
Labeler code
85318
Product ID
85318-203_45875797-5d3c-491e-e063-6294a90aed5d
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Maloney Plastic Surgery Skin Care, PLLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-08-27
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
38; 80 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 Mineral Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
316b7584-c782-fe9e-e063-6394a90a76feAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85318-203-50Tinted Mineral Sunscreen53 g in 1 BOTTLE, PUMPCREAM532

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85318-203TINTED MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALONEY PLASTIC SURGERY SKIN CARE, PLLC]1Current NDC, 1 package rows20250331_316b7584-c782-fe9e-e063-6394a90a76fe.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 207 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens SPF 50 Premium Moisturizing Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY0b2b1ed5-8e53-00f3-e063-6394a90a14f82025-06-24WarningsExact identifier
application number: M020
Walgreens Double Restorative Moisturizer Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY38569431-56b6-5f56-e063-6394a90ad24f2025-06-24WarningsExact identifier
application number: M020
Shade SPF30 Climate ControlOCTISALATE, OCTOCRYLENE, ZINC OXIDEMicro Current Technology, Inc.34080e9c-1637-cf25-e063-6394a90ace762025-06-24WarningsExact identifier
application number: M020
Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEAruba Aloe Balm NVcca65f6a-935f-48d4-a07d-831ab6027db02025-06-24WarningsExact identifier
application number: M020
Reef safe - Hydrating sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED385e8966-963d-0814-e063-6394a90a06e32025-06-24WarningsExact identifier
application number: M020
COLLAGEN GLOW MINERAL SUNSCREEN SPF 50ZINC OXIDENAKED SUNDAYS PTY LTDf76a4f0d-e3a6-4bd4-b1ab-09d690976d962025-06-23WarningsExact identifier
application number: M020
LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON ACIDO HIALURONICO FPS 20 SERUM FOUNDATION WITH HYALURONIC ACID SPF 20 CHAMPAGNE 170-NOCTINOXATE, ZINC OXIDEBEL STAR SAf459c27e-e607-47ba-e053-2a95a90a901f2025-06-22WarningsExact identifier
application number: M020
BISUTANG SunscreenBISUTANG SUNSCREENGuangdong Bisutang Biotechnology Co Ltd37fdb01b-929e-6a60-e063-6394a90a94e02025-06-20Exact identifier
application number: M020
AVON BEYOND GLOW SUN MILKAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENELG HOUSEHOLD & HEALTH CARE LTD.38045f75-42c0-7abb-e063-6294a90a8db62025-06-20WarningsExact identifier
application number: M020
Double Use Compact SPF 15 gold deluxe edition Claire 1-2-3OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBel Star S.A. (Colombia)b3747373-ef67-89ff-e053-2995a90afcde2025-06-20WarningsExact identifier
application number: M020
LBEL DIVINE Double Use compact SPF 15 gold deluxe edition Obscure 8-9ZINC OXIDE, TITANTIUM DIOXIDE, OCTINOXATEBel Star S.A. (Colombia)b5e47c63-7e82-34fc-e053-2a95a90a767c2025-06-20WarningsExact identifier
application number: M020
Proven Personalized Day Moisturizer Sunscreen SPF 30ZINC OXIDEProven Skincare5275d2c5-96e8-424d-a3c8-feea778191e42025-06-20WarningsExact identifier
application number: M020
LBEL CONCENTRE BASE SERUM ANTIEDAD EFECTO LIFTING FPS 15 ANTI AGING LIFTING SERUM FOUNDATION SPF 15 CHAMPAGNE 170-NOCTINOXATE, ZINC OXIDEBEL STAR SAf9266687-73d2-dac9-e053-6394a90ac2a12025-06-20WarningsExact identifier
application number: M020
LBEL DEFENSE TOTAL SUNSCREEN FOR FACE AND BODY SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENEBEL STAR SAfd0465aa-df1e-ce1c-e053-6294a90a23022025-06-20WarningsExact identifier
application number: M020
FEIBTH TALLOW SUNSCREENTALLOW SUNSCREENGuangzhou Qiexiran Cosmetics Co., Ltd.37ead2b1-12d4-af92-e063-6394a90af0d62025-06-19WarningsExact identifier
application number: M020
LipBOMBTITANIUM DIOXIDE, ZINC OXIDEFLEUR DE VIE LLC37ef4c1e-2183-a277-e063-6394a90ae2df2025-06-19Exact identifier
application number: M020
Bioresist reinforcing effect face moisturizer SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBEL STAR S A99d7525d-b636-7f8e-e053-2a95a90a20802025-06-19WarningsExact identifier
application number: M020
Ultra Balm Moisturizing Protective Balm for lips SPF 20 Nude TranslucideOCTINOXATE, ZINC OXIDEBEL STAR S Ac4d56723-3953-fb8e-e053-2a95a90a69d32025-06-19WarningsExact identifier
application number: M020
SPF 50 Daily UV Defense Broad Spectrum SunscreenOCTINOXATE, ZINC OXIDEVi Medical Products, INC2d814f8a-23b5-209f-e063-6394a90a50912025-06-19WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY RIKI LLC37f2c5ed-c2f5-e569-e063-6294a90a15b12025-06-19Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85318-203-508531802035053 g in 1 BOTTLE, PUMP (85318-203-50) 53 g2021-08-27NoNoCurrent