69231-034_cle Ccc Golden Medium

69231-034_cle Ccc Golden Medium
SPL v2
SPL
SPL Set ID de50e956-a014-4147-922b-63c95fa6f86b
Route
TOPICAL
Published
Effective Date 2022-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (2.1 mg) Octisalate (0.9 mg) Titanium Dioxide (2.751 mg)
Inactive Ingredients
Glycyrrhizinate Dipotassium Malva Sylvestris Flowering Top Water Cyclomethicone 5 Alkyl (c12-15) Benzoate Butylene Glycol Amiloxate Cyclomethicone 6 Cetyl Peg/ppg-10/1 Dimethicone (hlb 4) Niacinamide Dicaprylyl Carbonate Bemotrizinol Ceresin Diisostearyl Malate Sodium Chloride Disteardimonium Hectorite Sorbitan Sesquioleate Synthetic Wax (1200 Mw) Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone Sorbitan Olivate Ferric Oxide Yellow Mica Chlorphenesin Dipropylene Glycol Hydroxyacetophenone Dimethicone Corn Oil Ferric Oxide Red Caprylyl Glycol Bergamot Oil Orange Oil Silica Dimethyl Silylate Ferrosoferric Oxide Phenyl Trimethicone Adenosine Ylang-ylang Oil Melissa Officinalis Leaf Chrysanthemum Indicum Flower Green Tea Leaf Edetate Disodium Anhydrous Rosemary Aspalathus Linearis Leaf Thyme Jasminum Officinale Flower Lowbush Blueberry .alpha.-tocopherol Acetate Glycerin Achillea Millefolium Whole Alchemilla Xanthochlora Flowering Top Alcohol Primula Veris Whole Mentha Piperita Leaf Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-25

Description

Titanium Dioxide 9.17% 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 9.17% 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, Diisostearyl Malate, Sodium Chloride, Disteardimonium Hectorite, Polyester-1, Sorbitan Sesquioleate, Synthetic Wax, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Sorbitan Olivate, Silica Dimethyl Silylate, CI 77491, CI 77499, Dipropylene Glycol, Hydroxyacetophenone, Vegetable Oil, Chlorphenesin, Propylene Carbonate, Dimethicone, Caprylyl Glycol, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Oil, Cananga Odorata Flower Oil, Adenosine, 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 9.17%

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, Diisostearyl Malate, Sodium Chloride, Disteardimonium Hectorite, Polyester-1, Sorbitan Sesquioleate, Synthetic Wax, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Sorbitan Olivate, Silica Dimethyl Silylate, CI 77491, CI 77499, Dipropylene Glycol, Hydroxyacetophenone, Vegetable Oil, Chlorphenesin, Propylene Carbonate, Dimethicone, Caprylyl Glycol, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Oil, Cananga Odorata Flower Oil, Adenosine, 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 9.17%

Ethylhexyl Methoxycinnamate 7.00%

Ethylhexyl Salicylate 3.00%


Advanced Ingredient Data


Raw Label Data

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