TOTY SOLARIA MINERAL- titanium dioxide, zinc oxide cream

toty Solaria Mineral by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

Titanium Dioxide 7.0%

Zinc Oxide 6.0%

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

• 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)).

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.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. 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

INGREDIENTS AND APPEARANCE

TOTY SOLARIA MINERAL 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82141-3161
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	7 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
OXOTHIAZOLIDINE (UNII: M6U1ZG59XD)
FERRIC OXIDE RED (UNII: 1K09F3G675)
NYLON-12 (UNII: 446U8J075B)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
3-PHENYL-1-PROPANOL (UNII: U04IC2765C)
HYDROGENATED DIDECENE (UNII: 048B98MT5O)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PHENETHYL BENZOATE (UNII: 0C143929GK)
TOCOPHEROL (UNII: R0ZB2556P8)
PHYSALIS ANGULATA (UNII: W4TKW9D5GG)
PROPANEDIOL (UNII: 5965N8W85T)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ETHYL LINOLEATE (UNII: MJ2YTT4J8M)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
WATER (UNII: 059QF0KO0R)
ISODODECANE (UNII: A8289P68Y2)
ARGININE (UNII: 94ZLA3W45F)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FERULIC ACID (UNII: AVM951ZWST)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
3-O-ETHYL ASCORBIC ACID (UNII: 6MW60CB71P)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PANTHENOL TRIACETATE, (+)- (UNII: 1206E8961B)
CHLAMYDOMONAS REINHARDTII (UNII: QS58JP94CS)
MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)
DIMETHICONE (UNII: 92RU3N3Y1O)
PALMITOYL HYDROXYPROPYLTRIMONIUM AMYLOPECTIN/GLYCERIN CROSSPOLYMER (UNII: 7F9WLW26M2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82141-3161-1	1 in 1 CARTON	06/01/2023	01/31/2024
1		50 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 82141-3161-2	1 in 1 CARTON	06/01/2023
2		5 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 82141-3161-3	1 in 1 CARTON	01/08/2024
3		30 g in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 82141-3161-4	1 in 1 CARTON	06/01/2023
4		50 g in 1 BOTTLE; 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	06/01/2023

Labeler - Chipican LLC (118132015)

Establishment
Name	Address	ID/FEI	Business Operations
Industrial Farmaceutica Cantabria SA		470471158	manufacture(82141-3161) , label(82141-3161) , pack(82141-3161)