FDA.reportPublic FDA data

Tinted Mineral Sunscreen

Manufacturer
Topiderm, Inc.
Effective date
2025-04-09
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:58:50

Label at a glance#

ProductTinted Mineral Sunscreen SPF 50
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure7 sections

Indications and uses

Helps prevent sunburn If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally to face and neck and spread evenly 15 minutes before sun exposure Re-apply after swimming, excessive perspiring, or anytime after towel drying Use a water resistant sunscreen if swimming or sweating Use on children under 6 months of age: consult a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientPurpose
Zinc Oxide 11%Sunscreen
Titanium Dioxide 7.5%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product keep out of eyes, rinse with water to remove.

OTC - STOP USE SECTION

Stop use if signs of irritation or rash appear. If irritation or rash persists consult a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Sun Protection Measures

SPL UNCLASSIFIED SECTION

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sunscreen measures including:

  • limit time in the sun, especially from 10 a.m.-2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally to face and neck and spread evenly 15 minutes before sun exposure
  • Re-apply after swimming, excessive perspiring, or anytime after towel drying
  • Use a water resistant sunscreen if swimming or sweating
  • Use on children under 6 months of age: consult a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Dimethicone, Methyl Trimethicone, Isononyl Isononanoate, Oleth-3 Phosphate, PEG-9 Polydimethylsiloxyethyl Dimethicone, Alumina, Butylene Glycol, Octyldodecyl Neopentanoate, VP/Eicosene Copolymer, Sodium Hyaluronate, Tocopheryl Acetate, Caffeine, Polyisobutene, Iron Oxides, Sucrose, Glycerin, Silicone, Isopropyl Titanium Triisostearate, Polysorbate 20, Polyacrylate-13, Panthenol, Cetearyl Alcohol, Dicetyl Phosphate, Ceteth-20 Phosphate, PEG-8 Methyl Ether Triethoxysilane, Hydrogen Dimethicone Polyglyceryl-6 Polyricinoleate, Xanthan Gum, Sodium Hydroxide, Phenoxyethanol, Disodium EDTA.

PRINCIPAL DISPLAY PANEL - 99 g Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPLIMENTS OF
TOPIX
PHARMACEUTICALS, INC

MULTI-TASKING

Mineral
Lightly Tinted
Antioxidant
Sunscreen
SPF 50+

Broad Spectrum SPF 50+
Water Resistant 40 minutes

Net wt. 3.5 oz. (99 g)

Available
Custom Branded
800.445.2595
c.service@topixpharm.com

PRINCIPAL DISPLAY PANEL - 99 g Bottle Label
PRINCIPAL DISPLAY PANEL - 99 g Bottle Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51326-123-032025-04-09C16284748780-12cef2736-7f1e-d83d-e063-dadaa90ab31fTinted Mineral Sunscreen SPF 50
51326-123-032025-01-30C16284748780-12cef2736-7f1e-d83d-e063-dadaa90ab31fTinted Mineral Sunscreen SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51326-123-03Tinted Mineral SunscreenSPF 5099 g in 1 BOTTLELOTION995

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51326-123TINTED MINERAL SUNSCREEN SPF 50 (ZINC OXIDE AND TITANIUM DIOXIDE) LOTION [TOPIDERM, INC.]5Current NDC, 1 package rows20250410_13e5085f-df2b-46b2-b063-e58ce4379905.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51326-12351326-123-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
METHYL TRIMETHICONES73ZQI0GXMIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
OLETH-3 PHOSPHATE8Q0Z18J1VLIACT
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
ALUMINUM OXIDELMI26O6933IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT
HYALURONATE SODIUMYSE9PPT4THIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CAFFEINE3G6A5W338EIACT
POLYSORBATE 207T1F30V5YHIACT
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)1DXE3F3OZXIACT
DEXPANTHENOL1O6C93RI7ZIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
CETETH-20 PHOSPHATE921FTA1500IACT
TRIETHOXYSILANE8T460WDH89IACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM HYDROXIDE55X04QC32IIACT
PHENOXYETHANOLHIE492ZZ3TIACT
EDETATE DISODIUM7FLD91C86KIACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral Sunscreen SPF 50ZINC OXIDE AND TITANIUM DIOXIDETopiderm, Inc.13e5085f-df2b-46b2-b063-e58ce43799052025-04-09WarningsExact identifier
ndc (package): 51326-123-03
ndc (product): 51326-123
ndc11 (package): 51326012303
spl id: 10a3470a-33a2-4d1f-bc4e-da605c251d75
spl set id: 13e5085f-df2b-46b2-b063-e58ce4379905

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.