69231-025 Ccc Warm Medium

69231-025 Ccc Warm Medium
SPL v1
SPL
SPL Set ID b585f216-4234-47c5-9a6b-8b133ef48aae
Route
TOPICAL
Published
Effective Date 2018-11-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (2.1 mg) Octisalate (0.9 mg) Titanium Dioxide (2.52846 mg)
Inactive Ingredients
Water Cyclomethicone 5 Ferric Oxide Yellow Alkyl (c12-15) Benzoate Butylene Glycol Cyclomethicone 6 Amiloxate Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Mica Niacinamide Dicaprylyl Carbonate Bemotrizinol Ceresin Diisostearyl Malate Sodium Chloride Ferric Oxide Red Silica Dimethyl Silylate Disteardimonium Hectorite Sorbitan Sesquioleate Synthetic Wax (1200 Mw) Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone Sorbitan Olivate Ferrosoferric Oxide Corn Oil Chlorphenesin Dipropylene Glycol Bergamot Oil Orange Oil 1,2-hexanediol Propylene Carbonate Hydroxyacetophenone Dimethicone Cananga Oil Adenosine Edetate Disodium Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-11-27

Description

Titanium Dioxide 8.43% 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 8.43% 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, Iron Oxides (CI 77492), C12-15 Alkyl Benzoate, Butylene Glycol, Cyclohexasiloxane, Isoamyl p-Methoxycinnamate, Cetyl PEG/PPG-10/1 Dimethicone, Mica (CI 77019), Niacinamide, Dicaprylyl Carbonate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Ceresin, Diisostearyl Malate, Sodium Chloride, Iron Oxides (CI 77491), Polyester-1, Silica Dimethyl Silylate, Disteardimonium Hectorite, Sorbitan Sesquioleate, Synthetic Wax, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Sorbitan Olivate, Iron Oxides (CI 77499), Vegetable Oil, Chlorphenesin, Dipropylene Glycol, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Oil, 1,2-Hexanediol, Propylene Carbonate, Hydroxyacetophenone, Dimethicone, Cananga Odorata Flower Oil, Adenosine, 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, Tocopherol

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Titanium Dioxide 8.43%

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, Iron Oxides (CI 77492), C12-15 Alkyl Benzoate, Butylene Glycol, Cyclohexasiloxane, Isoamyl p-Methoxycinnamate, Cetyl PEG/PPG-10/1 Dimethicone, Mica (CI 77019), Niacinamide, Dicaprylyl Carbonate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Ceresin, Diisostearyl Malate, Sodium Chloride, Iron Oxides (CI 77491), Polyester-1, Silica Dimethyl Silylate, Disteardimonium Hectorite, Sorbitan Sesquioleate, Synthetic Wax, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Sorbitan Olivate, Iron Oxides (CI 77499), Vegetable Oil, Chlorphenesin, Dipropylene Glycol, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Oil, 1,2-Hexanediol, Propylene Carbonate, Hydroxyacetophenone, Dimethicone, Cananga Odorata Flower Oil, Adenosine, 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, Tocopherol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Titanium Dioxide 8.43%

Ethylhexyl Methoxycinnamate 7.00%

Ethylhexyl Salicylate 3.00%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)