69231-030_cle Ccc Neutral Medium

69231-030_cle Ccc Neutral Medium
SPL v2
SPL
SPL Set ID a297ff64-678c-4936-8384-022606a2f33c
Route
TOPICAL
Published
Effective Date 2022-10-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (2.1 mg) Octisalate (0.9 mg) Titanium Dioxide (2.7888 mg)
Inactive Ingredients
Water Cyclomethicone 5 Alkyl (c12-15) Benzoate Cyclomethicone 6 Butylene Glycol Amiloxate Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Niacinamide Dicaprylyl Carbonate Ferric Oxide Yellow Bemotrizinol Ceresin Diisostearyl Malate Sodium Chloride Disteardimonium Hectorite Mica Ferric Oxide Red Ferrosoferric Oxide Sorbitan Sesquioleate Synthetic Wax (1200 Mw) Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone Sorbitan Olivate Polyester-10 Silica Dimethyl Silylate Chlorphenesin Dipropylene Glycol Dimethicone Corn Oil 1,2-hexanediol Propylene Carbonate Hydroxyacetophenone Bergamot Oil Orange Oil Phenyl Trimethicone Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Adenosine Cananga Oil Edetate Disodium Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-18

Description

Titanium Dioxide 9.30% 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 9.30% 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, Cyclohexasiloxane, Butylene Glycol, Isoamyl p-Methoxycinnamate, Cetyl PEG/PPG-10/1 Dimethicone, Niacinamide, Dicaprylyl Carbonate, Iron Oxides (CI 77492), Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Ceresin, Diisostearyl Malate, Sodium Chloride, Mica (CI 77019), Iron Oxides (CI 77491), Disteardimonium Hectorite, Iron Oxides (CI 77499), Sorbitan Sesquioleate, Synthetic Wax, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Sorbitan Olivate, Polyester-1, Silica Dimethyl Silylate, Chlorphenesin, Dipropylene Glycol, Dimethicone, Vegetable Oil, 1,2-Hexanediol, Propylene Carbonate, Hydroxyacetophenone, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Oil, Phenyl Trimethicone, Dimethicone Crosspolymer, Adenosine, Cananga Odorata Flower Oil, Disodium EDTA, Natto Gum, Saussurea Involucrata Extract, Bambusa Vulgaris Leaf/Stem Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Cocos Nucifera (Coconut) Oil, 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, Tocopherol

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Titanium Dioxide 9.30%

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, Cyclohexasiloxane, Butylene Glycol, Isoamyl p-Methoxycinnamate, Cetyl PEG/PPG-10/1 Dimethicone, Niacinamide, Dicaprylyl Carbonate, Iron Oxides (CI 77492), Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Ceresin, Diisostearyl Malate, Sodium Chloride, Mica (CI 77019), Iron Oxides (CI 77491), Disteardimonium Hectorite, Iron Oxides (CI 77499), Sorbitan Sesquioleate, Synthetic Wax, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Sorbitan Olivate, Polyester-1, Silica Dimethyl Silylate, Chlorphenesin, Dipropylene Glycol, Dimethicone, Vegetable Oil, 1,2-Hexanediol, Propylene Carbonate, Hydroxyacetophenone, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Oil, Phenyl Trimethicone, Dimethicone Crosspolymer, Adenosine, Cananga Odorata Flower Oil, Disodium EDTA, Natto Gum, Saussurea Involucrata Extract, Bambusa Vulgaris Leaf/Stem Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Cocos Nucifera (Coconut) Oil, 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, Tocopherol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Titanium Dioxide 9.30%

Ethylhexyl Methoxycinnamate 7.00%

Ethylhexyl Salicylate 3.00%


Advanced Ingredient Data


Raw Label Data

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