Active Ingredients
Titanium Dioxide 7.0%
Zinc Oxide 6.0%
Toty Solaria Mineral Cream
FDA Label NDC 82141-3161
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chipican Llc for the product Toty Solaria Mineral (NDC 82141-3161). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - keep out of reach of children, dosage & administration, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
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
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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- Shake well before use
- Apply liberally 15 minutes before sun exposure
- Reapply:
- 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:
- Children under 6 months of age: Ask a doctor
After 80 minutes of swimming or sweating
Immediately after towel drying
At least every 2 hours
Limit time in the sun, especially from 10 a.m. - 2 p.m.
Wear long-sleeved shirts, pants, hats, and sunglasses
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)).
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
* Please review the disclaimer below.
