69231-032_cle Ccc Warm Deep

69231-032_cle Ccc Warm Deep
SPL v2
SPL
SPL Set ID 6ab3e360-8104-4439-93fb-e11bc4a77558
Route
TOPICAL
Published
Effective Date 2022-11-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (2.1 mg) Octisalate (0.6 mg) Titanium Dioxide (0.51 mg) Avobenzone (0.156 mg)
Inactive Ingredients
Cyclomethicone 5 Water Alkyl (c12-15) Benzoate Cyclomethicone 6 Ferric Oxide Yellow Butylene Glycol Amiloxate Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Niacinamide Diphenylsiloxy Phenyl Trimethicone Mica Bemotrizinol Poly(methyl Methacrylate; 450000 Mw) Ferric Oxide Red Candelilla Wax Sodium Chloride Ferrosoferric Oxide Polyester-10 Silica Dimethyl Silylate Disteardimonium Hectorite Triethoxycaprylylsilane Synthetic Beeswax Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone Sorbitan Olivate Hydroxyacetophenone Corn Oil Chlorphenesin Dipropylene Glycol Caprylyl Glycol Bergamot Oil Orange Oil Propylene Carbonate Dimethiconol (2000 Cst) Ylang-ylang Oil Dimethicone Lowbush Blueberry .alpha.-tocopherol Acetate Glycerin Adenosine Edetate Disodium Anhydrous Melissa Officinalis Leaf Chrysanthemum Indicum Flower Green Tea Leaf Rosemary Aspalathus Linearis Leaf Thyme Jasminum Officinale Flower Glycyrrhizinate Dipotassium Malva Sylvestris Flowering Top Achillea Millefolium Whole Alchemilla Xanthochlora Flowering Top Alcohol Primula Veris Whole Mentha Piperita Leaf Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-11-08

Description

Titanium Dioxide 1.70% Ethylhexyl Methoxycinnamate 7.00% Ethylhexyl Salicylate 2.00% Avobenzone 0.52%


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 1.70% Ethylhexyl Methoxycinnamate 7.00% Ethylhexyl Salicylate 2.00% Avobenzone 0.52%

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, Butylene Glycol, Diphenylsiloxy Phenyl Trimethicone, C12-15 Alkyl Benzoate, CI 77492, Isoamyl p-Methoxycinnamate, Cetyl PEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Niacinamide, CI 77491, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, CI 77499, Polymethyl Methacrylate, Sodium Chloride, Euphorbia Cerifera (Candelilla) Wax, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Sorbitan Olivate, Synthetic Beeswax, Disteardimonium Hectorite, Triethoxycaprylylsilane, Trihydroxystearin, Dipropylene Glycol, Hydroxyacetophenone, Vegetable Oil, Chlorphenesin, Caprylyl Glycol, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Oil, Propylene Carbonate, Dimethiconol, Adenosine, Cananga Odorata Flower Oil, Dimethicone, 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, Dipotassium Glycyrrhizate, Malva Sylvestris (Mallow) Extract, Achillea Millefolium Extract, Alchemilla Vulgaris Extract, Alcohol, Primula Veris Extract, Mentha Piperita (Peppermint) Leaf Extract, Mica, Tocopherol, Polyester-1, Silica Dimethyl Silylate

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Titanium Dioxide 1.70%

Ethylhexyl Methoxycinnamate 7.00%

Ethylhexyl Salicylate 2.00%

Avobenzone 0.52%


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, Butylene Glycol, Diphenylsiloxy Phenyl Trimethicone, C12-15 Alkyl Benzoate, CI 77492, Isoamyl p-Methoxycinnamate, Cetyl PEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Niacinamide, CI 77491, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, CI 77499, Polymethyl Methacrylate, Sodium Chloride, Euphorbia Cerifera (Candelilla) Wax, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Sorbitan Olivate, Synthetic Beeswax, Disteardimonium Hectorite, Triethoxycaprylylsilane, Trihydroxystearin, Dipropylene Glycol, Hydroxyacetophenone, Vegetable Oil, Chlorphenesin, Caprylyl Glycol, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Oil, Propylene Carbonate, Dimethiconol, Adenosine, Cananga Odorata Flower Oil, Dimethicone, 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, Dipotassium Glycyrrhizate, Malva Sylvestris (Mallow) Extract, Achillea Millefolium Extract, Alchemilla Vulgaris Extract, Alcohol, Primula Veris Extract, Mentha Piperita (Peppermint) Leaf Extract, Mica, Tocopherol, Polyester-1, Silica Dimethyl Silylate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Titanium Dioxide 1.70%

Ethylhexyl Methoxycinnamate 7.00%

Ethylhexyl Salicylate 2.00%

Avobenzone 0.52%


Advanced Ingredient Data


Raw Label Data

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