Tone Control Morning Cream Spf 15

Drug Facts

Composition & Product

Active Ingredients

Octocrylene (5.0 g) Octisalate (2.0 g)

Inactive Ingredients

Aloe Vera Leaf Water Butyloctyl Salicylate Cetearyl Olivate Sorbitan Olivate Glyceryl Monostearate Potassium Azeloyl Diglycinate Glycerin Niacinamide Polyglyceryl-10 Laurate Silicon Dioxide Caffeine Phenoxyethanol Caprylyl Glycol Dimethicone Sodium Stearoyl Glutamate Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Ethyl Ferulate Ethylhexylglycerin Arnica Montana Flower

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-07-18

Medication Information

Warnings and Precautions

Warnings • Skin Cancer/Skin Aging Alert: Spending too much time in the sun increases your risk of

skin cancer and early skin aging. This product has been shown to only help prevent sunburn,

not skin cancer or early skin aging. • 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.

Indications and Usage

Uses: Helps prevent sunburn.

Dosage and Administration

Directions • Apply generously 15 minutes before sun exposure. • Use in the morning.

• Reapply every 2 hours. • Use a water resistant sunscreen if swimming or sweating. • Rub

cream gently into your face and neck, avoiding the eyes.

Description

DRUG FACTS Active Ingredients Octocrylene 5% Octisalate 2%

Section 50565-1

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

Section 51727-6

Inactive Ingredients Aloe Barbadensis Leaf Juice, Water, Butyloctyl Salicylate, Cetear-

yl Olivate, Sorbitan Olivate, Glyceryl Stearate, Potassium Azeloyl Diglycinate, Glycerin, Niacina-

mide, Polyglyceryl-10 Laurate, Sodium Hyaluronate, Silica, Caffeine, Phenoxyethanol, Caprylyl

Glycol, Dimethicone, Sodium Stearoyl Glutamate, Hydroxyethyl Acrylate/Sodium

Acryloyldimethyl Taurate Copolymer, Ethyl Ferulate, Ethylhexylglycerin, Arnica Montana Flower

Extract

Section 55105-1

Purpose .... Sunscreem

Section 55106-9

DRUG FACTS

Active Ingredients

Octocrylene 5%

Octisalate 2%

Section 60561-8

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

Product Labeling

Tone Control Morning Cream SPF 15

SPF 15

Distributed by Geologie

2578 Broadway #A212

New York, NY 10025

20 ml .67 fl oz

20 mL Label

60 mL Label

res

Structured Label Content

Indications and Usage (34067-9)

Uses: Helps prevent sunburn.

Dosage and Administration (34068-7)

Directions • Apply generously 15 minutes before sun exposure. • Use in the morning.

• Reapply every 2 hours. • Use a water resistant sunscreen if swimming or sweating. • Rub

cream gently into your face and neck, avoiding the eyes.

Warnings and Precautions (34071-1)

Warnings • Skin Cancer/Skin Aging Alert: Spending too much time in the sun increases your risk of

skin cancer and early skin aging. This product has been shown to only help prevent sunburn,

not skin cancer or early skin aging. • 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.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Inactive Ingredients Aloe Barbadensis Leaf Juice, Water, Butyloctyl Salicylate, Cetear-

yl Olivate, Sorbitan Olivate, Glyceryl Stearate, Potassium Azeloyl Diglycinate, Glycerin, Niacina-

mide, Polyglyceryl-10 Laurate, Sodium Hyaluronate, Silica, Caffeine, Phenoxyethanol, Caprylyl

Glycol, Dimethicone, Sodium Stearoyl Glutamate, Hydroxyethyl Acrylate/Sodium

Acryloyldimethyl Taurate Copolymer, Ethyl Ferulate, Ethylhexylglycerin, Arnica Montana Flower

Extract

Section 55105-1 (55105-1)

Purpose .... Sunscreem

Section 55106-9 (55106-9)

DRUG FACTS

Active Ingredients

Octocrylene 5%

Octisalate 2%

Section 60561-8 (60561-8)

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

Product Labeling

Tone Control Morning Cream SPF 15

SPF 15

Distributed by Geologie

2578 Broadway #A212

New York, NY 10025

20 ml .67 fl oz

20 mL Label

60 mL Label

res

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses: Helps prevent sunburn.", "34068-7": "Directions • Apply generously 15 minutes before sun exposure. • Use in the morning. • Reapply every 2 hours. • Use a water resistant sunscreen if swimming or sweating. • Rub cream gently into your face and neck, avoiding the eyes.", "34071-1": "Warnings • Skin Cancer/Skin Aging Alert : Spending too much time in the sun increases your risk of skin cancer and early skin aging. This product has been shown to only help prevent sunburn, not skin cancer or early skin aging. • 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.", "50565-1": "Keep out of the reach of children . If swallowed get medical help or contact a Poison Control center right away.", "51727-6": "Inactive Ingredients Aloe Barbadensis Leaf Juice, Water, Butyloctyl Salicylate, Cetear- yl Olivate, Sorbitan Olivate, Glyceryl Stearate, Potassium Azeloyl Diglycinate, Glycerin, Niacina- mide, Polyglyceryl-10 Laurate, Sodium Hyaluronate, Silica, Caffeine, Phenoxyethanol, Caprylyl Glycol, Dimethicone, Sodium Stearoyl Glutamate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Ethyl Ferulate, Ethylhexylglycerin, Arnica Montana Flower Extract", "55105-1": "Purpose .... Sunscreem", "55106-9": "DRUG FACTS Active Ingredients Octocrylene 5% Octisalate 2%", "60561-8": "Other information • Protect the product in this container from excessive heat and direct sun.", "Product Labeling": "Tone Control Morning Cream SPF 15 SPF 15 Distributed by Geologie 2578 Broadway #A212 New York, NY 10025 20 ml .67 fl oz 20 mL Label 60 mL Label res"}

Tone Control Morning Cream Spf 15

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information