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NDC 69231-0027-02 CLE CCC Golden Medium Deep 2.1; .9; 2.51454 mg/30mL; mg/30mL; mg/30mL Details
CLE CCC Golden Medium Deep 2.1; .9; 2.51454 mg/30mL; mg/30mL; mg/30mL
CLE CCC Golden Medium Deep 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 | 69231-0027 |
|---|---|
| Product ID | 69231-027_7c2408f5-6ee1-3d9c-e053-2a91aa0a1bae |
| 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 Golden Medium Deep |
| 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; 2.51454 |
| 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 69231-0027-02 (69231002702)
| NDC Package Code | 69231-027-02 |
|---|---|
| Billing NDC | 69231002702 |
| Package | 1 CONTAINER in 1 PACKAGE (69231-027-02) / 30 mL in 1 CONTAINER (69231-027-01) |
| Marketing Start Date | 2018-12-03 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL b7a4847f-b84d-4f36-8787-104eccd838a0 Details
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, Cyclomethicone, Iron Oxides (CI 77492), C12-15 Alkyl Benzoate, Butylene Glycol, Cyclopentasiloxane, Isoamyl p-Methoxycinnamate, Cetyl PEG/PPG-10/1 Dimethicone, Mica (CI 77019), Niacinamide, Dicaprylyl Carbonate, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Cyclohexasiloxane, Ceresin, Iron Oxides (CI 77491), Diisostearyl Malate, Sodium Chloride, Polyester-1, Silica, Silica Dimethyl Silylate, Disteardimonium Hectorite, Sorbitan Sesquioleate, Synthetic Wax, 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
INGREDIENTS AND APPEARANCE
| CLE CCC GOLDEN MEDIUM DEEP
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(69231-027) | |