Sunbetter Tone Smart Spf 75 Sunscreen Lotion

Sunbetter Tone Smart Spf 75 Sunscreen Lotion
SPL v5
SPL
SPL Set ID b878ee3b-6897-3c4a-e053-2995a90afed7
Route
TOPICAL
Published
Effective Date 2021-01-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (35 mg) Zinc Oxide (100 mg)
Inactive Ingredients
Sodium Benzoate Sodium Chloride Styrene/acrylamide Copolymer (500000 Mw) .alpha.-tocopherol Acetate, Dl- Ginger Allantoin Aluminum Oxide Medium-chain Triglycerides Caprylyl Glycol Starch, Corn Triethyl Citrate Ubidecarenone Water Silicon Dioxide Dodecamethylpentasiloxane Opuntia Ficus-indica Stem Phenylethyl Alcohol Phenoxyethanol Poly(methyl Methacrylate; 450000 Mw) Squalane Stearic Acid Caper Berry Cetyl Dimethicone 45 .alpha.-bisabolol, (+/-)- Butyloctyl Salicylate Camellia Oleifera Leaf Ceric Oxide Disteardimonium Hectorite Himanthalia Elongata Mica Niacinamide Dimethicone Glycerin Ferric Oxide Red Black Olive Olea Europaea Leaf Panthenol Phenyl Trimethicone Polyglyceryl-4 Oleate Polygonum Aviculare Top Polyhydroxystearic Acid (2300 Mw) Potassium Sorbate 1,2-hexanediol Tropolone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-01

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Dosage and Administration

Apply liberally and evenly 15 minutes before sun exposure.

Reapply:

after 80 minutes of swimming or sweating.

immediately after towel drying.

at least every 2 hours.

use a water resistant sunscreen if swimming or sweating.

Description

Drug Facts

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.

Directions

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.

Drug Facts

Drug Facts

Other Information

Protect this product from excessive heat and direct sun.

Active Ingredients

Titanium Dioxide 3.5%

Zinc Oxide 10.0%

Inactive Ingredients

1,2-Hexanediol, Acrylates/Dimethicone Copolymer, Allantoin, Alumina, Bis-Vinyl Dimethicone/Dimethicone Copolymer, Bisabolol, Butyloctyl Salicylate, Camellia Oleifera Leaf Extract, Capparis Spinosa Fruit Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cerium Oxide, Cetyl Dimethicone, Dimethicone, Disteardimonium Hectorite, Glycerin, Himanthalia Elongata Extract, Iron Oxides (CI 77491, CI 77492, CI 77499), Mica, Niacinamide, Olea Europaea (Olive) Fruit Extract, Olea Europaea (Olive) Leaf Extract, Opuntia Ficus-Indica Stem Extract, Panthenol, Phenethyl Alcohol, Phenoxyethanol, Phenyl Trimethicone, Plankton Extract, Polyglyceryl-3 Sorbityl Linseedate, Polyglyceryl-4 Oleate, Polygonum Aviculare Extract, Polyhydroxystearic Acid, Polymethyl Methacrylate, Potassium Sorbate, Silica, Sodium Benzoate, Sodium Chloride, Squalane, Stearic Acid, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Triethyl Citrate, Tropolone, Ubiquinone, Water, Zea Mays (Corn) Starch, Zingiber Officinale (Ginger) Root Extract.

Questions Or Comments?

800-538-5600

Principal Display Panel

sunbetter™

Advanced Mineral Protection

BROAD SPECTRUM SPF 75

SUNSCREEN LOTION

TONE SMART

Water-Resistant (80 Minutes)

Mineral Actives

skinbetter science®

1.7 FL.OZ. (50 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)

Apply liberally and evenly 15 minutes before sun exposure.

Reapply:

after 80 minutes of swimming or sweating.

immediately after towel drying.

at least every 2 hours.

use a water resistant sunscreen if swimming or sweating.

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.

Directions

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.

Drug Facts

Drug Facts

Other Information (Other information)

Protect this product from excessive heat and direct sun.

Active Ingredients

Titanium Dioxide 3.5%

Zinc Oxide 10.0%

Inactive Ingredients (Inactive ingredients)

1,2-Hexanediol, Acrylates/Dimethicone Copolymer, Allantoin, Alumina, Bis-Vinyl Dimethicone/Dimethicone Copolymer, Bisabolol, Butyloctyl Salicylate, Camellia Oleifera Leaf Extract, Capparis Spinosa Fruit Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cerium Oxide, Cetyl Dimethicone, Dimethicone, Disteardimonium Hectorite, Glycerin, Himanthalia Elongata Extract, Iron Oxides (CI 77491, CI 77492, CI 77499), Mica, Niacinamide, Olea Europaea (Olive) Fruit Extract, Olea Europaea (Olive) Leaf Extract, Opuntia Ficus-Indica Stem Extract, Panthenol, Phenethyl Alcohol, Phenoxyethanol, Phenyl Trimethicone, Plankton Extract, Polyglyceryl-3 Sorbityl Linseedate, Polyglyceryl-4 Oleate, Polygonum Aviculare Extract, Polyhydroxystearic Acid, Polymethyl Methacrylate, Potassium Sorbate, Silica, Sodium Benzoate, Sodium Chloride, Squalane, Stearic Acid, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Triethyl Citrate, Tropolone, Ubiquinone, Water, Zea Mays (Corn) Starch, Zingiber Officinale (Ginger) Root Extract.

Questions Or Comments? (Questions or comments?)

800-538-5600

Principal Display Panel

sunbetter™

Advanced Mineral Protection

BROAD SPECTRUM SPF 75

SUNSCREEN LOTION

TONE SMART

Water-Resistant (80 Minutes)

Mineral Actives

skinbetter science®

1.7 FL.OZ. (50 ML)


Advanced Ingredient Data


Raw Label Data

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