Toty Solaria Body

Toty Solaria Body
SPL v1
SPL
SPL Set ID 1a121b17-3621-6bc1-e063-6394a90ac9a1
Route
TOPICAL
Published
Effective Date 2024-07-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (5 g) Octinoxate (7.5 g) Zinc Oxide (2 g) Titanium Dioxide (0.4 g)
Inactive Ingredients
Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Lactic Acid Ethylhexylglycerin Phenoxyethanol Laureth-7 Triethoxycaprylylsilane Butyl Methacrylate/methyl Methacrylate/methacrylic Acid/styrene Crosspolymer Triisopropanolamine Green Tea Leaf Edetate Sodium Butylated Hydroxytoluene Propylene Glycol Phlebodium Aureum Leaf Dichlorobenzyl Alcohol .alpha.-tocopherol Acetate Chlorella Vulgaris Polyacrylamide (crosslinked; 0.01-0.2 Mole Percent Bisacrylamide) Cetyl Dimethicone 150 Silicon Dioxide Linalool, (+/-)- Aluminum Oxide Glycerin Peg-8 Laurate Water Hexylene Glycol Cyclomethicone 5 Peg/ppg-20/6 Dimethicone Cyclomethicone 6 C13-14 Isoparaffin Soybean Lecithin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-26

Description

Octinoxate 7.5% Octocrylene 5.0% Titanium Dioxide 0.4% Zinc Oxide 2.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Dosage and 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

Description

Octinoxate 7.5% Octocrylene 5.0% Titanium Dioxide 0.4% Zinc Oxide 2.0%

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

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

Other Information

Do not expose the product to high temperatures

Protect the product in this container from excessive heat and direct sun.

Active Ingredients

Octinoxate 7.5%

Octocrylene 5.0%

Titanium Dioxide 0.4%

Zinc Oxide 2.0%

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


Structured Label Content

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

Dosage and Administration (34068-7)

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

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Sunscreen

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

Other Information (Other information)

Do not expose the product to high temperatures

Protect the product in this container from excessive heat and direct sun.

Active Ingredients

Octinoxate 7.5%

Octocrylene 5.0%

Titanium Dioxide 0.4%

Zinc Oxide 2.0%

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


Advanced Ingredient Data


Raw Label Data

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