TOTY SOLARIA BODY- octinoxate, octocrylene, titanium dioxide, zinc oxide cream

toty Solaria Body by

Drug Labeling and Warnings

toty Solaria Body by is a Otc medication manufactured, distributed, or labeled by CHIPICAN LLC, Industrial Farmaceutica Cantabria SA, Industrial Farmaceutica Cantabria, SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octinoxate 7.5%

Octocrylene 5.0%

Titanium Dioxide 0.4%

Zinc Oxide 2.0%

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

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

INGREDIENTS AND APPEARANCE

TOTY SOLARIA BODY 
octinoxate, octocrylene, titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82141-7373
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
LACTIC ACID (UNII: 33X04XA5AT)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LAURETH-7 (UNII: Z95S6G8201)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
EDETATE SODIUM (UNII: MP1J8420LU)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
DICHLOROBENZYL ALCOHOL (UNII: 1NKX3648J9)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE) (UNII: RHA9LWJ494)
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
ALUMINUM OXIDE (UNII: LMI26O6933)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-8 LAURATE (UNII: 762O8IWA10)
WATER (UNII: 059QF0KO0R)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG/PPG-20/6 DIMETHICONE (UNII: PWZ7N4UIKE)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82141-7373-1	1 in 1 CARTON	07/26/2024
1		154.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/26/2024

Labeler - CHIPICAN LLC (118132015)

Establishment
Name	Address	ID/FEI	Business Operations
Industrial Farmaceutica Cantabria SA		470471158	manufacture(82141-7373) , label(82141-7373) , pack(82141-7373)

Establishment
Name	Address	ID/FEI	Business Operations
Industrial Farmaceutica Cantabria, SA		462112621	analysis(82141-7373)