Active Ingredients
Octinoxate 7.5%
Octocrylene 5.0%
Titanium Dioxide 0.4%
Zinc Oxide 2.0%
Toty Solaria Body Cream
FDA Label NDC 82141-7373
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 Body (NDC 82141-7373). 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
Apply liberally 15 minutes before sun exposure
Reapply:
After 40 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 cancewr 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; Glycerin: Hexylene Glycol; Cyclopentasiloxane; PEG/PPG-20/6 Dimethicone;
Polycrylamide; Styrene/Acrylates Copolymer; Cyclohexasiloxane; Phenoxyethanol;
C13-14 Isoalkane; Propylene Glycol; Polypodium leucotomos Leaf Extract; Cetyl
Dimethicone; Laureth-7; Camellia sinensis (Green tea) Leaf Extract; Tocopheryl
Acetate; PEG-8 Laurate; Tetrasodium EDTA; Dicholorobenzyl Alcohol; Fragrance;
Alumina; Plankton Extract ( Chlorella vulgaris Extract); Triethoxycaprylylsilane;
Simethicone; Linalool; Lactic Acid; Lecithin; Ethylhexylglycerin, Triisopropanolamine;
Pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, BHT.
Package Label. Principal Display Panel
toty. ®
SOLARIA
BODY
SPF 50
REFRESHING ANTIOXIDANT
SUNSCREEN
PROTECTOR SOLAR
REFRESCANTE ANTIOXIDANTE
SUNSCREEN BROAD SPECTRUM SPF 50
WATER & SWEAT RESISTANT (40 MINUTES)
PROTECTOR SOLAR AMPLIO ESPECTRO SPF 50
RESISTENTE AL AGUA Y AL SUDOR (40 MINUTOS)
5.07 fl. oz./ 150 ml
* Please review the disclaimer below.
