FDA.reportPublic FDA data

toty Solaria Mineral

Manufacturer
Chipican LLC | Industrial Farmaceutica Cantabria SA
Effective date
2024-02-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:08:13

Label at a glance#

Producttoty Solaria Mineral
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure11 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

Storage and handling

Do not expose the product to high temperatures Protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 7.0%

Zinc Oxide 6.0%

Purpose

OTC - PURPOSE SECTION

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

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Shake well before use
  • Apply liberally 15 minutes before sun exposure
  • Reapply:

After 80 minutes of swimming or sweating

Immediately after towel drying

At least every 2 hours

  • Sun Protection Measures. 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 10 a.m. - 2 p.m.
Wear long-sleeved shirts, pants, hats, and sunglasses

  • Children under 6 months of age: Ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • Do not expose the product to high temperatures
  • Protect the product in this container from excessive heat and direct sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Dimethicone, Isododecane, C12-15 Alkyl Benzoate, Hydrogenated Didecene, Butyloctyl Salicylate, Aluminum Hydroxide, Styrene/Acrylates Copolymer, Phenethyl Benzoate, PEG-9 Polydimethylsiloxyethyl Dimethicone, Nylon-12, Calaguala ( Polypodium leucotomos) Leaf Extract, Ferulic Acid, 3-O-Ethyl Ascorbic Acid, Tocopheryl Acetate, Tocopherol, Cutleaf Grouncherry (Physalis angulata) Extract, Green Tea ( Camellia sinensis) Extract, Plankton ( Chlamydomonas reinhardti) Extract, Arginine, Melanin, Caprylyl Glycol, Isohexadecane, Disteardimonium Hectorite, Hydrogen Dimethicone, Phenylpropanol, Polyhydroxystearic Acid, Magnesium Sulfate, Dimethicone/PEG-10/15 Crosspolymer, Propanediol, Triethoxycaprylylsilane, Propylene Carbonate, Caprylic/Capric Triglyceride, Panthenyl Triacetate, Butylene Glycol, Propylene Glycol, Ethyl Linoleate, Oleyl Alcohol, Pentylene Glycol, Oxothiazolidine, Dipropylene Glycol, Sodium Citrate, Palmitoyl Hydroxypropyltrimonium Amylopectin/Glycerin Crosspolymer, 1,2-Hexanediol, Lecithin, Sodium Benzoate, Hydrogenated Lecithin, Phenoxyethanol, Ethylhexylglycerin, Iron Oxides (Ferric Oxide Red (CI 77491), Ferric Oxide Yellow (CI 77491), Ferrosoferric Oxide (CI 77499)).

Package Label.Principal Display Panel- Sample

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 82141-3161-2 (toty Solaria Mineral, Sample)

toty.

SOLARIA

MINERAL

SPF 50+

ANTIOXIDANT

SUNSCREEN SERUM

SERUM ANTIOXIDANTE

PROTECTOR SOLAR

.....................................................................................

BROAD SPECTRUM SPF 50+

VERY WATER RESISTANT

(80 MINUTES)

AMPLIO ESPECTRO SPF 50+

MUY RESISTENTE AL AGUA

(80 MINUTOS)

0.17 oz/5g

Toty Solaria Mineral (Sample)Toty Solaria Mineral (Sample)

Package Label.Principal Display Panel

NDC 82141-3161-1 (toty Solaria Mineral)

toty.

SOLARIA

MINERAL

SPF 50+

ANTIOXIDANT

SUNSCREEN SERUM

SERUM ANTIOXIDANTE

PROTECTOR SOLAR

.....................................................................................

BROAD SPECTRUM SPF 50+

VERY WATER RESISTANT (80 MINUTES)

AMPLIO ESPECTRO SPF 50+

MUY RESISTENTE AL AGUA (80 MINUTOS)

1.69 fl. oz/50 mL

Toty Solaria MineralToty Solaria Mineral

Package Label. Princip[al Display Panel- Travel Size)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 82141-3161-3 (toty Solaria Mineral, Travel Size)

toty.

SOLARIA

MINERAL

SPF 50+

ANTIOXIDANT

SUNSCREEN SERUM

SERUM ANTIOXIDANTE

PROTECTOR SOLAR

.....................................................................................

BROAD SPECTRUM SPF 50+

VERY WATER RESISTANT (80 MINUTES)

AMPLIO ESPECTRO SPF 50+

MUY RESISTENTE AL AGUA (80 MINUTOS)

1.0 fl. oz/30 mL

toty Solaria Mineral Travel Sizetoty Solaria Mineral Travel Size

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82141-3161-1toty Solaria Mineral50 g in 1 TUBECREAM503
82141-3161-1toty Solaria Mineral1 in 1 CARTONCREAM13
82141-3161-2toty Solaria Mineral5 g in 1 TUBECREAM53
82141-3161-2toty Solaria Mineral1 in 1 CARTONCREAM13
82141-3161-3toty Solaria Mineral30 g in 1 BOTTLECREAM303
82141-3161-3toty Solaria Mineral1 in 1 CARTONCREAM13
82141-3161-4toty Solaria Mineral1 in 1 CARTONCREAM13
82141-3161-4toty Solaria Mineral50 g in 1 BOTTLECREAM503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82141-3161TOTY SOLARIA MINERAL (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [CHIPICAN LLC]3Current NDC, 8 package rows20240202_e9d590d8-e71a-0715-e053-2a95a90a5acf.zip

Products#

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

DailyMed product names page 1 of 2 · 56 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82141-316182141-3161-1, 82141-3161-2, 82141-3161-3, 82141-3161-4

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 54 matching rows.

Name, UNII, Kind table
NameUNIIKind
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
ISOHEXADECANE918X1OUF1EIACT
POLYHYDROXYSTEARIC ACID STEARATE8KQ7I65XZEIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
OXOTHIAZOLIDINEM6U1ZG59XDIACT
FERRIC OXIDE RED1K09F3G675IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
NYLON-12446U8J075BIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
3-PHENYL-1-PROPANOLU04IC2765CIACT
HYDROGENATED DIDECENE048B98MT5OIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
PHENETHYL BENZOATE0C143929GKIACT
TOCOPHEROLR0ZB2556P8IACT
PHYSALIS ANGULATAW4TKW9D5GGIACT
PROPANEDIOL5965N8W85TIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
PHLEBODIUM AUREUM LEAFBG58BW230GIACT
DIMETHICONE/PEG-10/15 CROSSPOLYMER21AS8B1BSSIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
ETHYL LINOLEATEMJ2YTT4J8MIACT
OLEYL ALCOHOL172F2WN8DVIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMERV5RS026Q0HIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
ISODODECANEA8289P68Y2IACT
ARGININE94ZLA3W45FIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
FERULIC ACIDAVM951ZWSTIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PROPYLENE CARBONATE8D08K3S51EIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
BUTYLENE GLYCOL3XUS85K0RAIACT

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
toty Solaria MineralTITANIUM DIOXIDE, ZINC OXIDEChipican LLCe9d590d8-e71a-0715-e053-2a95a90a5acf2024-02-01WarningsExact identifier
ndc (package): 82141-3161-1
ndc (package): 82141-3161-4
ndc (package): 82141-3161-3
ndc (package): 82141-3161-2
ndc (product): 82141-3161
ndc11 (package): 82141316103
ndc11 (package): 82141316102
ndc11 (package): 82141316104
ndc11 (package): 82141316101
spl id: 1052c87e-42c3-60a2-e063-6394a90a970d
spl set id: e9d590d8-e71a-0715-e053-2a95a90a5acf

Reported adverse events (FAERS/openFDA)#

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