FDA.reportPublic FDA data

MINERAL TINTED SPF 30

Manufacturer
BOTANICAL SCIENCE, INC.
Effective date
2025-03-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:56:43

Label at a glance#

ProductMINERAL TINTED SPF 30
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure9 sections

Indications and uses

HELPS PREVENT SUNBURN.

Dosage and administration

APPLY GENEROUSLY 15 MINUTES BEFORE SUN EXPOSURE. REAPPLY AT LEAST EVERY 2 HOURS. IF SWIMMING OR SWEATING, USE A WATER-RESISTANT SUNSCREEN. FOR CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

TITANIUM DIOXIDE 2.5%

ZINC OXIDE 6.0%

PURPOSE

OTC - PURPOSE SECTION

SUNSCREEN

USES

INDICATIONS & USAGE SECTION

HELPS PREVENT SUNBURN.

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY.

  • Do not use on damaged or broken skin.
  • When using this product keep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctor if rash occurs.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

APPLY GENEROUSLY 15 MINUTES BEFORE SUN EXPOSURE. REAPPLY AT LEAST EVERY 2 HOURS. IF SWIMMING OR SWEATING, USE A WATER-RESISTANT SUNSCREEN. FOR CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR.

SUN PROTECTION MEASURES

OTHER SAFETY INFORMATION

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 VALUE OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING: LIMIT TIME IN THE SUN, ESPECIALLY FROM 10AM - 2PM, WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

AQUA, CAPRYLIC/CAPRIC TRIGLYCERIDE, CYCLOPENTASILOXANE, PROPANEDIOL, GLYCERIN, C12-15 ALKYL BENZOATE, DIMETHICONE, GLYCERYL STEARATE, PEG-100 STEARATE, CETYL ALCOHOL, SODIUM HYALURONATE, SODIUM PCA, PHYTIC ACID, CAMELLIA OLEIFERA LEAF EXTRACT, CHAMOMILLA RECUTITA FLOWER EXTRACT, CUCUMIS SATIVUS FRUIT EXTRACT, IRON OXIDES, CYCLOHEXASILOXANE, GLYCERYL CAPRYLATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, SUCROSE COCOATE, CITRIC ACID, GLYCERYL ISOSTEARATE, POLYHYDROXYSTEARIC ACID, SODIUM CITRATE, CAPRYLYL METHICONE, ALUMINA, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, CHLORPHENESIN, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, ALLANTOIN, XANTHAN GUM, GLYCERYL UNDECYLENATE, PANTHENOL, POLYSORBATE 60, SORBITAN ISOSTEARATE, PHENOXYETHANOL.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MINERAL TINTED SPF 30MINERAL TINTED SPF 30

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70712-104-11MINERAL TINTED SPF 30100 mL in 1 BOTTLELOTION1001
70712-104-12MINERAL TINTED SPF 30472 mL in 1 BOTTLELOTION4721

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70712-104MINERAL TINTED SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BOTANICAL SCIENCE, INC.]1Current NDC, 2 package rows20250308_2f9e2252-fb54-363f-e063-6294a90aa7c9.zip

Products#

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

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70712-10470712-104-11, 70712-104-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Name, UNII, Kind table
NameUNIIKind
CYCLOPENTASILOXANE0THT5PCI0RIACT
CHAMOMILEFGL3685T2XIACT
SUCROSE COCOATE3H18P0UK73IACT
POLYSORBATE 60CAL22UVI4MIACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE25G622K2RAIACT
PHYTIC ACID7IGF0S7R8IIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
DIMETHICONE92RU3N3Y1OIACT
ALUMINALMI26O6933IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
IRON OXIDES1K09F3G675IACT
CUCUMIS SATIVUS (CUCUMBER) FRUITYY7C30VXJTIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
GLYCERYL STEARATE230OU9XXE4IACT
GLYCERYL ISOSTEARATEHYE7O27HAOIACT
CYCLOHEXASILOXANEXHK3U310BAIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONEX75PL53TZJIACT
ALLANTOIN344S277G0ZIACT
PANTHENOLWV9CM0O67ZIACT
SODIUM HYALURONATEYSE9PPT4THIACT
SODIUM PCA469OTG57A2IACT
CAMELLIA OLEIFERA LEAF5077EL0C60IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CETYL ALCOHOL936JST6JCNIACT
WATER059QF0KO0RIACT
PEG-100 STEARATEYD01N1999RIACT
XANTHAN GUMTTV12P4NEEIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERINPDC6A3C0OXIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
CITRIC ACID2968PHW8QPIACT
PROPANEDIOL5965N8W85TIACT
CAPRYLYL METHICONEQ95M2P1KJLIACT
CHLORPHENESINI670DAL4SZIACT

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
MINERAL TINTED SPF 30TITANIUM DIOXIDE, ZINC OXIDEBOTANICAL SCIENCE, INC.2f9e2252-fb54-363f-e063-6294a90aa7c92025-03-04WarningsExact identifier
ndc (package): 70712-104-11
ndc (package): 70712-104-12
ndc (product): 70712-104
ndc11 (package): 70712010411
ndc11 (package): 70712010412
spl id: 2f9e225e-7dc5-7d0e-e063-6394a90aadd6
spl set id: 2f9e2252-fb54-363f-e063-6294a90aa7c9

Reported adverse events (FAERS/openFDA)#

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