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NDC 39765-0036-01 Tinted Moisturizer SPF 46 Universal Tint 7.5; 12 g/100mL; g/100mL Details
Tinted Moisturizer SPF 46 Universal Tint 7.5; 12 g/100mL; g/100mL
Tinted Moisturizer SPF 46 Universal Tint is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Neutraderm, Inc.. The primary component is OCTINOXATE; ZINC OXIDE.
Product Information
| NDC | 39765-0036 |
|---|---|
| Product ID | 39765-036_7ad72c6c-8991-4b24-a3b2-08008ab1c171 |
| 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 | Tinted Moisturizer SPF 46 Universal Tint |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Zinc oxide, Octinoxate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 7.5; 12 |
| Active Ingredient Units | g/100mL; g/100mL |
| Substance Name | OCTINOXATE; ZINC OXIDE |
| Labeler Name | Neutraderm, Inc. |
| Pharmaceutical Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part352 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 39765-0036-01 (39765003601)
| NDC Package Code | 39765-036-01 |
|---|---|
| Billing NDC | 39765003601 |
| Package | 50 mL in 1 BOTTLE (39765-036-01) |
| Marketing Start Date | 2020-01-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL b2086d72-7ac4-4712-951f-3c1f9a72fb34 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions • Apply to face and neck, avoiding the eye area. Wait at least 30 minutes before sun exposure, or as directed by a physician. Reapply after 80 minutes of swimming or sweating. Reapply immediately after towel drying at least every 2 hours.
Precautions • 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 value of SPF 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m.–2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months of age: Ask a physician.
SPL UNCLASSIFIED SECTION
Inactive Ingredients Water/Aqua/Eau, Cyclopentasiloxane, Niacinamide, Oleth-3 Phosphate, Octyldodecyl Neopentanoate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glycerin, Polygonum Aviculare Extract, Sodium Hyaluronate, Tocopheryl Acetate, Ethylhexylglycerin, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, PEG-7 Trimethylolpropane Coconut Ether, Polyisobutene, Triethoxycaprylylsilane, Disodium EDTA, Iron Oxides, Phenoxyethanol
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| TINTED MOISTURIZER SPF 46 UNIVERSAL TINT
zinc oxide, octinoxate cream |
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| Labeler - Neutraderm, Inc. (146224444) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Neutraderm, Inc. | 146224444 | manufacture(39765-036) | |