Active Ingredient
Titanium Dioxide- 10.4%
Toty Ilumina Cc Creamy Compact Refill 1c Cream
FDA Label NDC 82141-2359
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 Ilumina Cc Creamy Compact Refill 1c (NDC 82141-2359). 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 ingredient, 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
- Apply liberally 15 minutes behore 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:
After 80 minutes of swimming or sweating
immediately after towel drying
Atleat every 2 hours
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 sudden changes in temperature or extreme temperatures
- Protect the product from direct sunlight
- Store below 30°C/86°F
Inactive Ingredients
NDCs 82141-2357-1, 82141-2358-1, 82141-2360-1, 82141-2363-1
Hydrogenated Polyisobutene; Ethylhexyl Palmitate; Nylon-12; Paraffin; Hydrogenated Microcrystalline Wax;
Polymethyl Methacrylate; Mica; Butylene Glycol Cocoate; Methyl Methacrylate Crosspolymer; Carnauba (Copernica cerifera) Wax; Silica; Hydrogenated Castor Oil; Alumina, Squalene, Calaguala (Polypodium leucotomos) Leaf Extract; Propylene Glycol; Glyceryl Caprylate; Tocopheryl Acetate; Castor (Ricinus communis) Seed Oil; Water; Simethicone; Tocopherol; Beta-Sitosterol; Soybean (Glycine soja) Oil; Paraffinum Liquidum; Fragrance, Linalool, Iron Oxides* (Ferric Oxide Red (CI 77491), Ferric Oxide Yellow (CI 77492), Ferrosoferric Oxide (CI 77499)); Titanium Dioxide* (CI 77891), Bismuth Oxychloride* (CI 77163). * Contains one or more of these ingredients.
NDCs 82141-2359-1, 82141-2362-1
Hydrogenated Polyisobutene; Ethylhexyl Palmitate; Nylon-12; Paraffin; Mica; Hydrogenated Microcrystalline
Wax; Polymethyl Methacrylate; Butylene Glycol Cocoate; Methyl Methacrylate Crosspolymer; Carnauba (Copernica cerifera) Wax; Silica; Hydrogenated Castor Oil; Alumina, Squalene, Calaguala (Polypodium leucotomos) Leaf Extract; Propylene Glycol; Glyceryl Caprylate; Tocopheryl Acetate; Castor (Ricinus communis) Seed Oil; Water; Simethicone; Tocopherol; Beta-Sitosterol; Soybean (Glycine soja) Oil; Paraffinum Liquidum; Fragrance, Linalool, Iron Oxides* (Ferric Oxide Red (CI 77491), Ferric Oxide Yellow (CI 77492), Ferrosoferric Oxide (CI 77499)); Titanium Dioxide* (CI 77891), Bismuth Oxychloride* (CI 77163). * Contains one or more of these ingredients.
NDCs 82141-2361-1, 82141-2365-1, 82141-2368-1
Hydrogenated Polyisobutene; Ethylhexyl Palmitate; Nylon-12; Paraffin; Hydrogenated Microcrystalline Wax;
Polymethyl Methacrylate; Butylene Glycol Cocoate; Mica; Methyl Methacrylate Crosspolymer; Carnauba (Copernica cerifera) Wax; Silica; Hydrogenated Castor Oil; Alumina, Squalene, Calaguala (Polypodium leucotomos) Leaf Extract; Propylene Glycol; Glyceryl Caprylate; Tocopheryl Acetate; Castor (Ricinus communis) Seed Oil; Water; Simethicone; Tocopherol; Beta-Sitosterol; Soybean (Glycine soja) Oil; Paraffinum Liquidum; Fragrance, Linalool, Iron Oxides* (Ferric Oxide Red (CI 77491), Ferric Oxide Yellow (CI 77492), Ferrosoferric Oxide (CI 77499)); Titanium Dioxide* (CI 77891), Bismuth Oxychloride* (CI 77163). * Contains one or more of these ingredients.
NDC 82141-2364-1
Hydrogenated Polyisobutene; Ethylhexyl Palmitate; Nylon-12; Paraffin; Hydrogenated Microcrystalline Wax; Mica;
Polymethyl Methacrylate; Butylene Glycol Cocoate; Methyl Methacrylate Crosspolymer; Carnauba (Copernica cerifera) Wax; Silica;
Hydrogenated Castor Oil; Alumina, Squalene, Calaguala (Polypodium leucotomos) Leaf Extract; Propylene Glycol; Glyceryl Caprylate; Tocopheryl Acetate; Castor (Ricinus communis) Seed Oil; Water; Simethicone; Tocopherol; Beta-Sitosterol; Soybean (Glycine soja) Oil; Triethoxycaprylylsilane; Paraffinum Liquidum; Fragrance, Linalool, Iron Oxides* (Ferric Oxide Red (CI 77491), Ferric Oxide Yellow (CI 77492), Ferrosoferric Oxide (CI 77499)); Titanium Dioxide* (CI 77891), Bismuth Oxychloride* (CI 77163). * Contains one or more of these ingredients.
NDC 82141-2366-1
Hydrogenated Polyisobutene; Ethylhexyl Palmitate; Nylon-12; Paraffin; Mica; Polymethyl Methacrylate;
Hydrogenated Microcrystalline Wax; Butylene Glycol Cocoate; Methyl Methacrylate Crosspolymer; Carnauba (Copernica cerifera) Wax; Silica; Hydrogenated Castor Oil; Alumina, Squalene, Calaguala (Polypodium leucotomos) Leaf Extract; Propylene Glycol; Glyceryl Caprylate; Tocopheryl Acetate; Castor (Ricinus communis) Seed Oil; Water; Simethicone; Tocopherol; Beta-Sitosterol; Soybean (Glycine soja) Oil; Paraffinum Liquidum; Fragrance, Linalool, Iron Oxides* (Ferric Oxide Red (CI 77491), Ferric Oxide Yellow (CI 77492), Ferrosoferric Oxide (CI 77499)); Titanium Dioxide* (CI 77891), Bismuth Oxychloride* (CI 77163). * Contains one or more of these ingredients.
NDC 82141-2367-1
Hydrogenated Polyisobutene; Ethylhexyl Palmitate; Nylon-12; Paraffin; Hydrogenated Microcrystalline Wax;
Polymethyl Methacrylate; Mica; Butylene Glycol Cocoate; Methyl Methacrylate Crosspolymer; Carnauba (Copernica cerifera) Wax; Silica; Hydrogenated Castor Oil; Alumina, Squalene, Calaguala (Polypodium leucotomos) Leaf Extract; Propylene Glycol; Glyceryl Caprylate; Tocopheryl Acetate; Castor (Ricinus communis) Seed Oil; Water; Simethicone; Tocopherol; Beta-Sitosterol; Soybean (Glycine soja) Oil; Triethoxycaprylylsilane; Paraffinum Liquidum; Fragrance, Linalool, Iron Oxides* (Ferric Oxide Red (CI 77491), Ferric Oxide Yellow (CI 77492), Ferrosoferric Oxide (CI 77499)); Titanium Dioxide* (CI 77891), Bismuth Oxychloride* (CI 77163). * Contains one or more of these ingredients.
NDCs 82141-2369-1
Hydrogenated Polyisobutene; Ethylhexyl Palmitate; Nylon-12; Paraffin; Hydrogenated Microcrystalline Wax;
Butylene Glycol Cocoate; Polymethyl Methacrylate; Mica; Carnauba (Copernica cerifera) Wax; Methyl Methacrylate Crosspolymer; Silica; Hydrogenated Castor Oil; Alumina, Squalene, Calaguala (Polypodium leucotomos) Leaf Extract; Propylene Glycol; Glyceryl Caprylate; Tocopheryl Acetate; Castor (Ricinus communis) Seed Oil; Water; Simethicone; Tocopherol; Beta-Sitosterol; Soybean (Glycine soja) Oil; Triethoxycaprylylsilane; Paraffinum Liquidum; Fragrance, Linalool, Iron Oxides* (Ferric Oxide Red (CI 77491), Ferric Oxide Yellow (CI 77492), Ferrosoferric Oxide (CI 77499)); Titanium Dioxide* (CI 77891), Bismuth Oxychloride* (CI 77163). * Contains one or more of these ingredients.
NDCs 82141-2370-1, 82141-2371-1
Hydrogenated Polyisobutene; Ethylhexyl Palmitate; Nylon-12; Paraffin; Hydrogenated Microcrystalline Wax;
Butylene Glycol Cocoate; Mica; Polymethyl Methacrylate; Carnauba (Copernica cerifera) Wax; Methyl Methacrylate Crosspolymer; Silica; Hydrogenated Castor Oil; Alumina, Squalene, Calaguala (Polypodium leucotomos) Leaf Extract; Propylene Glycol; Glyceryl Caprylate; Tocopheryl Acetate; Castor (Ricinus communis) Seed Oil; Water; Simethicone; Tocopherol; Beta-Sitosterol; Soybean (Glycine soja) Oil; Triethoxycaprylylsilane; Paraffinum Liquidum; Fragrance, Linalool, Iron Oxides* (Ferric Oxide Red (CI 77491), Ferric Oxide Yellow (CI 77492), Ferrosoferric Oxide (CI 77499)); Titanium Dioxide* (CI 77891), Bismuth Oxychloride* (CI 77163). * Contains one or more of these ingredients.
Package Label.Principal Display Panel- 1N
NDC 82141-2357-1 (toty Ilumina CC Creamy Compact Refill 1N)
toty.
REFILL/RECARGA
ILUMINA
CC CREAMY COMPACT REFILL
SPF 50+
TONE-ADAPTING, SILKY-SMOOTH COMPACT
COMPACTO SUAVE, SEDOSO, TONO-ADAPTABLE
.....................................................................................
BROAD SPECTRUM SPF 50+
MINERAL SUNSCREEN
VERY WATER RESISTANT (80 MINUTES)
PROTECTOR SOLAR MINERAL
AMPLIO ESPECTRO SPF 50+
MUY RESISTENTE AL AGUA (80 MINUTOS)
0.35 oz/10g
Package Label.Principal Display Panel- 1W
NDC 82141-2358-1 (toty Ilumina CC Creamy Compact Refill 1W)
toty.
REFILL/RECARGA
ILUMINA
CC CREAMY COMPACT REFILL
SPF 50+
TONE-ADAPTING, SILKY-SMOOTH COMPACT
COMPACTO SUAVE, SEDOSO, TONO-ADAPTABLE
.....................................................................................
BROAD SPECTRUM SPF 50+
MINERAL SUNSCREEN
VERY WATER RESISTANT (80 MINUTES)
PROTECTOR SOLAR MINERAL
AMPLIO ESPECTRO SPF 50+
MUY RESISTENTE AL AGUA (80 MINUTOS)
0.35 oz/10g
Package Label.Principal Display Panel- 1C
NDC 82141-2359-1 (toty Ilumina CC Creamy Compact Refill 1C)
toty.
REFILL/RECARGA
ILUMINA
CC CREAMY COMPACT REFILL
SPF 50+
TONE-ADAPTING, SILKY-SMOOTH COMPACT
COMPACTO SUAVE, SEDOSO, TONO-ADAPTABLE
.....................................................................................
BROAD SPECTRUM SPF 50+
MINERAL SUNSCREEN
VERY WATER RESISTANT (80 MINUTES)
PROTECTOR SOLAR MINERAL
AMPLIO ESPECTRO SPF 50+
MUY RESISTENTE AL AGUA (80 MINUTOS)
0.35 oz/10g
Package Label.Principal Display Panel- 2N
NDC 82141-2360-1 (toty Ilumina CC Creamy Compact Refill 2N)
toty.
REFILL/RECARGA
ILUMINA
CC CREAMY COMPACT REFILL
SPF 50+
TONE-ADAPTING, SILKY-SMOOTH COMPACT
COMPACTO SUAVE, SEDOSO, TONO-ADAPTABLE
.....................................................................................
BROAD SPECTRUM SPF 50+
MINERAL SUNSCREEN
VERY WATER RESISTANT (80 MINUTES)
PROTECTOR SOLAR MINERAL
AMPLIO ESPECTRO SPF 50+
MUY RESISTENTE AL AGUA (80 MINUTOS)
0.35 oz/10g
Package Label.Principal Display Panel- 2W
NDC 82141-2361-1 (toty Ilumina CC Creamy Compact Refill 2W)
toty.
REFILL/RECARGA
ILUMINA
CC CREAMY COMPACT REFILL
SPF 50+
TONE-ADAPTING, SILKY-SMOOTH COMPACT
COMPACTO SUAVE, SEDOSO, TONO-ADAPTABLE
.....................................................................................
BROAD SPECTRUM SPF 50+
MINERAL SUNSCREEN
VERY WATER RESISTANT (80 MINUTES)
PROTECTOR SOLAR MINERAL
AMPLIO ESPECTRO SPF 50+
MUY RESISTENTE AL AGUA (80 MINUTOS)
0.35 oz/10g
Package Label.Principal Display Panel- 2C
NDC 82141-2362-1 (toty Ilumina CC Creamy Compact Refill 2C)
toty.
REFILL/RECARGA
ILUMINA
CC CREAMY COMPACT REFILL
SPF 50+
TONE-ADAPTING, SILKY-SMOOTH COMPACT
COMPACTO SUAVE, SEDOSO, TONO-ADAPTABLE
.....................................................................................
BROAD SPECTRUM SPF 50+
MINERAL SUNSCREEN
VERY WATER RESISTANT (80 MINUTES)
PROTECTOR SOLAR MINERAL
AMPLIO ESPECTRO SPF 50+
MUY RESISTENTE AL AGUA (80 MINUTOS)
0.35 oz/10g
Package Label.Principal Display Panel- 3N
NDC 82141-2363-1 (toty Ilumina CC Creamy Compact Refill 3N)
toty.
REFILL/RECARGA
ILUMINA
CC CREAMY COMPACT REFILL
SPF 50+
TONE-ADAPTING, SILKY-SMOOTH COMPACT
COMPACTO SUAVE, SEDOSO, TONO-ADAPTABLE
.....................................................................................
BROAD SPECTRUM SPF 50+
MINERAL SUNSCREEN
VERY WATER RESISTANT (80 MINUTES)
PROTECTOR SOLAR MINERAL
AMPLIO ESPECTRO SPF 50+
MUY RESISTENTE AL AGUA (80 MINUTOS)
0.35 oz/10g
Package Label.Principal Display Panel- 3W
NDC 82141-2364-1 (toty Ilumina CC Creamy Compact Refill 3W)
toty.
REFILL/RECARGA
ILUMINA
CC CREAMY COMPACT REFILL
SPF 50+
TONE-ADAPTING, SILKY-SMOOTH COMPACT
COMPACTO SUAVE, SEDOSO, TONO-ADAPTABLE
.....................................................................................
BROAD SPECTRUM SPF 50+
MINERAL SUNSCREEN
VERY WATER RESISTANT (80 MINUTES)
PROTECTOR SOLAR MINERAL
AMPLIO ESPECTRO SPF 50+
MUY RESISTENTE AL AGUA (80 MINUTOS)
0.35 oz/10g
Package Label.Principal Display Panel- 3C
NDC 82141-2365-1 (toty Ilumina CC Creamy Compact Refill 3C)
toty.
REFILL/RECARGA
ILUMINA
CC CREAMY COMPACT REFILL
SPF 50+
TONE-ADAPTING, SILKY-SMOOTH COMPACT
COMPACTO SUAVE, SEDOSO, TONO-ADAPTABLE
.....................................................................................
BROAD SPECTRUM SPF 50+
MINERAL SUNSCREEN
VERY WATER RESISTANT (80 MINUTES)
PROTECTOR SOLAR MINERAL
AMPLIO ESPECTRO SPF 50+
MUY RESISTENTE AL AGUA (80 MINUTOS)
0.35 oz/10g
Package Label.Principal Display Panel- 4N
NDC 82141-2366-1 (toty Ilumina CC Creamy Compact Refill 4N)
toty.
REFILL/RECARGA
ILUMINA
CC CREAMY COMPACT REFILL
SPF 50+
TONE-ADAPTING, SILKY-SMOOTH COMPACT
COMPACTO SUAVE, SEDOSO, TONO-ADAPTABLE
.....................................................................................
BROAD SPECTRUM SPF 50+
MINERAL SUNSCREEN
VERY WATER RESISTANT (80 MINUTES)
PROTECTOR SOLAR MINERAL
AMPLIO ESPECTRO SPF 50+
MUY RESISTENTE AL AGUA (80 MINUTOS)
0.35 oz/10g
Package Label.Principal Display Panel- 4W
NDC 82141-2367-1 (toty Ilumina CC Creamy Compact Refill 4W)
toty.
REFILL/RECARGA
ILUMINA
CC CREAMY COMPACT REFILL
SPF 50+
TONE-ADAPTING, SILKY-SMOOTH COMPACT
COMPACTO SUAVE, SEDOSO, TONO-ADAPTABLE
.....................................................................................
BROAD SPECTRUM SPF 50+
MINERAL SUNSCREEN
VERY WATER RESISTANT (80 MINUTES)
PROTECTOR SOLAR MINERAL
AMPLIO ESPECTRO SPF 50+
MUY RESISTENTE AL AGUA (80 MINUTOS)
0.35 oz/10g
Package Label.Principal Display Panel- 4C
NDC 82141-2368-1 (toty Ilumina CC Creamy Compact Refill 4C)
toty.
REFILL/RECARGA
ILUMINA
CC CREAMY COMPACT REFILL
SPF 50+
TONE-ADAPTING, SILKY-SMOOTH COMPACT
COMPACTO SUAVE, SEDOSO, TONO-ADAPTABLE
.....................................................................................
BROAD SPECTRUM SPF 50+
MINERAL SUNSCREEN
VERY WATER RESISTANT (80 MINUTES)
PROTECTOR SOLAR MINERAL
AMPLIO ESPECTRO SPF 50+
MUY RESISTENTE AL AGUA (80 MINUTOS)
0.35 oz/10g
Package Label.Principal Display Panel- 5W
NDC 82141-2369-1 (toty Ilumina CC Creamy Compact Refill 5W)
toty.
REFILL/RECARGA
ILUMINA
CC CREAMY COMPACT REFILL
SPF 50+
TONE-ADAPTING, SILKY-SMOOTH COMPACT
COMPACTO SUAVE, SEDOSO, TONO-ADAPTABLE
.....................................................................................
BROAD SPECTRUM SPF 50+
MINERAL SUNSCREEN
VERY WATER RESISTANT (80 MINUTES)
PROTECTOR SOLAR MINERAL
AMPLIO ESPECTRO SPF 50+
MUY RESISTENTE AL AGUA (80 MINUTOS)
0.35 oz/10g
Package Label.Principal Display Panel- 5W1
NDC 82141-2370-1 (toty Ilumina CC Creamy Compact Refill 5W1)
toty.
REFILL/RECARGA
ILUMINA
CC CREAMY COMPACT REFILL
SPF 50+
TONE-ADAPTING, SILKY-SMOOTH COMPACT
COMPACTO SUAVE, SEDOSO, TONO-ADAPTABLE
.....................................................................................
BROAD SPECTRUM SPF 50+
MINERAL SUNSCREEN
VERY WATER RESISTANT (80 MINUTES)
PROTECTOR SOLAR MINERAL
AMPLIO ESPECTRO SPF 50+
MUY RESISTENTE AL AGUA (80 MINUTOS)
0.35 oz/10g
Package Label.Principal Display Panel- 5W2
NDC 82141-2371-1 (toty Ilumina CC Creamy Compact Refill 5W2)
toty.
REFILL/RECARGA
ILUMINA
CC CREAMY COMPACT REFILL
SPF 50+
TONE-ADAPTING, SILKY-SMOOTH COMPACT
COMPACTO SUAVE, SEDOSO, TONO-ADAPTABLE
.....................................................................................
BROAD SPECTRUM SPF 50+
MINERAL SUNSCREEN
VERY WATER RESISTANT (80 MINUTES)
PROTECTOR SOLAR MINERAL
AMPLIO ESPECTRO SPF 50+
MUY RESISTENTE AL AGUA (80 MINUTOS)
0.35 oz/10g
* Please review the disclaimer below.
