toty solaria mineral

toty solaria mineral
SPL v3
SPL
SPL Set ID e9d590d8-e71a-0715-e053-2a95a90a5acf
Route
topical
Published
Effective Date 2024-01-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (7 g) zinc oxide (6 g)
Inactive Ingredients
peg-9 polydimethylsiloxyethyl dimethicone isohexadecane polyhydroxystearic acid stearate triethoxycaprylylsilane oxothiazolidine ferric oxide red nylon-12 ethylhexylglycerin 3-phenyl-1-propanol hydrogenated didecene butyloctyl salicylate phenethyl benzoate tocopherol physalis angulata propanediol lecithin, soybean hydrogenated soybean lecithin phlebodium aureum leaf dimethicone/peg-10/15 crosspolymer ferric oxide yellow ethyl linoleate oleyl alcohol green tea leaf butyl methacrylate/methyl methacrylate/methacrylic acid/styrene crosspolymer 1,2-hexanediol aluminum hydroxide water isododecane arginine .alpha.-tocopherol acetate ferulic acid caprylyl glycol propylene carbonate phenoxyethanol propylene glycol ferrosoferric oxide alkyl (c12-15) benzoate butylene glycol pentylene glycol dipropylene glycol 3-o-ethyl ascorbic acid sodium benzoate magnesium sulfate heptahydrate hydrogen dimethicone (20 cst) anhydrous trisodium citrate disteardimonium hectorite medium-chain triglycerides panthenol triacetate, (+)- chlamydomonas reinhardtii melanin synthetic (tyrosine, peroxide) dimethicone palmitoyl hydroxypropyltrimonium amylopectin/glycerin crosspolymer

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2023-06-01 Until 2024-01-31
Purpose

Sunscreen

Description

Titanium Dioxide 7.0% Zinc Oxide 6.0%

Medication Information

Warnings

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

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
Purpose

Sunscreen

Dosage and Administration

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

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)).

Description

Titanium Dioxide 7.0% Zinc Oxide 6.0%

Section 50565-1

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

Active Ingredients

Titanium Dioxide 7.0%

Zinc Oxide 6.0%

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

Package Label.principal Display Panel Sample

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

Package Label. Princip[al Display Panel Travel Size

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

Structured Label Content

Warnings

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

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
Purpose

Sunscreen

Dosage and Administration (34068-7)

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 (Other information)
  • Do not expose the product to high temperatures
  • Protect the product in this container from excessive heat and direct sun
Inactive Ingredients

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)).

Section 50565-1 (50565-1)

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

Active Ingredients

Titanium Dioxide 7.0%

Zinc Oxide 6.0%

Package Label.principal Display Panel (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

Package Label.principal Display Panel Sample (Package Label.Principal Display Panel- Sample)

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

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

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

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:45.923534 · Updated: 2026-03-14T23:02:29.359860