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NDC 69231-0030-02 CLE CCC Neutral Medium 2.1; .9; 2.7888 mg/30mL; mg/30mL; mg/30mL Details
CLE CCC Neutral Medium 2.1; .9; 2.7888 mg/30mL; mg/30mL; mg/30mL
CLE CCC Neutral Medium is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by KW ABSC, INC.. The primary component is OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE.
Product Information
| NDC | 69231-0030 |
|---|---|
| Product ID | 69231-030_eb58fa24-2877-ba75-e053-2a95a90a85a6 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | CLE CCC Neutral Medium |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Titanium Dioxide, Octinoxate, Octisalate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 2.1; .9; 2.7888 |
| Active Ingredient Units | mg/30mL; mg/30mL; mg/30mL |
| Substance Name | OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE |
| Labeler Name | KW ABSC, INC. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part352 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 69231-0030-02 (69231003002)
| NDC Package Code | 69231-030-02 |
|---|---|
| Billing NDC | 69231003002 |
| Package | 1 CONTAINER in 1 PACKAGE (69231-030-02) / 30 mL in 1 CONTAINER (69231-030-01) |
| Marketing Start Date | 2022-10-18 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL a297ff64-678c-4936-8384-022606a2f33c Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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
INGREDIENTS AND APPEARANCE
| CLE CCC NEUTRAL MEDIUM
titanium dioxide, octinoxate, octisalate cream |
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| Labeler - KW ABSC, INC. (079548604) |
| Registrant - KW ABSC, INC. (079548604) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Cit Co., Ltd | 690081646 | manufacture(69231-030) | |