69231-031_cle Ccc Cool Medium Deep

69231-031_cle Ccc Cool Medium Deep
SPL v2
SPL
SPL Set ID 2e0365f9-d3c6-4404-90ac-772a829b3ade
Route
TOPICAL
Published
Effective Date 2022-10-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (2.1 mg) Octisalate (0.9 mg) Titanium Dioxide (2.535 mg)
Inactive Ingredients
Water Cyclomethicone 5 Alkyl (c12-15) Benzoate Cyclomethicone 6 Ferric Oxide Yellow Butylene Glycol Amiloxate Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Niacinamide Dicaprylyl Carbonate Mica Bemotrizinol Ceresin Ferric Oxide Red Diisostearyl Malate Sodium Chloride Ferrosoferric Oxide Polyester-10 Silica Dimethyl Silylate Disteardimonium Hectorite Sorbitan Sesquioleate Synthetic Wax (1200 Mw) Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone Sorbitan Olivate Corn Oil Chlorphenesin Dipropylene Glycol Bergamot Oil Orange Oil Propylene Carbonate 1,2-hexanediol Hydroxyacetophenone Dimethicone Phenyl Trimethicone Cananga Oil Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Adenosine Edetate Disodium Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-24

Description

Titanium Dioxide 8.45% Ethylhexyl Methoxycinnamate 7.00% Ethylhexyl Salicylate 3.00%


Medication Information

Warnings and Precautions

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 using and ask a doctor if rash occurs.

Indications and Usage

Helps prevent sunburn

Dosage and Administration

Apply liberally 15 minutes before sun exposure. Reapply at least every two 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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses

Ask a doctor to use for children under 6 months

Description

Titanium Dioxide 8.45% Ethylhexyl Methoxycinnamate 7.00% Ethylhexyl Salicylate 3.00%

Section 50565-1

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Section 51727-6

Water, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Butylene Glycol, CI 77492, Isoamyl p-Methoxycinnamate, Cyclohexasiloxane, Cetyl PEG/PPG-10/1 Dimethicone, Niacinamide, Dicaprylyl Carbonate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Ceresin, Mica, CI 77491, Diisostearyl Malate, Sodium Chloride, CI 77499, Disteardimonium Hectorite, Sorbitan Sesquioleate, Synthetic Wax, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Sorbitan Olivate, Polyester-1, Silica Dimethyl Silylate, Dipropylene Glycol, Hydroxyacetophenone, Chlorphenesin, Propylene Carbonate, Vegetable Oil, Dimethicone, Caprylyl Glycol, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Oil, Triethoxycaprylylsilane, Adenosine, Cananga Odorata Flower Oil, Disodium EDTA, Natto Gum, Saussurea Involucrata Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Tocopheryl Acetate, Hydrolyzed Hyaluronic Acid, Glycerin, Melissa Officinalis Leaf Extract, Chrysanthemum Indicum Flower Extract, Camellia Sinensis Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Aspalathus Linearis Leaf Extract, Thymus Vulgaris (Thyme) Flower/Leaf Extract, Jasminum Officinale (Jasmine) Flower Water, Veronica Officinalis Extract, Malva Sylvestris (Mallow) Extract, Achillea Millefolium Extract, Alchemilla Vulgaris Extract, Alcohol, Primula Veris Extract, Mentha Piperita (Peppermint) Leaf Extract, Dipotassium Glycyrrhizate, Tocopherol

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Titanium Dioxide 8.45%

Ethylhexyl Methoxycinnamate 7.00%

Ethylhexyl Salicylate 3.00%


Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn

Dosage and Administration (34068-7)

Apply liberally 15 minutes before sun exposure. Reapply at least every two 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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses

Ask a doctor to use for children under 6 months

Warnings and Precautions (34071-1)

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 using and ask a doctor if rash occurs.

Section 50565-1 (50565-1)

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Section 51727-6 (51727-6)

Water, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Butylene Glycol, CI 77492, Isoamyl p-Methoxycinnamate, Cyclohexasiloxane, Cetyl PEG/PPG-10/1 Dimethicone, Niacinamide, Dicaprylyl Carbonate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Ceresin, Mica, CI 77491, Diisostearyl Malate, Sodium Chloride, CI 77499, Disteardimonium Hectorite, Sorbitan Sesquioleate, Synthetic Wax, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Sorbitan Olivate, Polyester-1, Silica Dimethyl Silylate, Dipropylene Glycol, Hydroxyacetophenone, Chlorphenesin, Propylene Carbonate, Vegetable Oil, Dimethicone, Caprylyl Glycol, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Oil, Triethoxycaprylylsilane, Adenosine, Cananga Odorata Flower Oil, Disodium EDTA, Natto Gum, Saussurea Involucrata Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Tocopheryl Acetate, Hydrolyzed Hyaluronic Acid, Glycerin, Melissa Officinalis Leaf Extract, Chrysanthemum Indicum Flower Extract, Camellia Sinensis Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Aspalathus Linearis Leaf Extract, Thymus Vulgaris (Thyme) Flower/Leaf Extract, Jasminum Officinale (Jasmine) Flower Water, Veronica Officinalis Extract, Malva Sylvestris (Mallow) Extract, Achillea Millefolium Extract, Alchemilla Vulgaris Extract, Alcohol, Primula Veris Extract, Mentha Piperita (Peppermint) Leaf Extract, Dipotassium Glycyrrhizate, Tocopherol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Titanium Dioxide 8.45%

Ethylhexyl Methoxycinnamate 7.00%

Ethylhexyl Salicylate 3.00%


Advanced Ingredient Data


Raw Label Data

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