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NDC 39765-0035-01 Broad Spectrum SPF45 7.5; 12 g/100g; g/100g Details
Broad Spectrum SPF45 7.5; 12 g/100g; g/100g
Broad Spectrum SPF45 is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Neutraderm, Inc.. The primary component is OCTINOXATE; ZINC OXIDE.
Product Information
| NDC | 39765-0035 |
|---|---|
| Product ID | 39765-035_1638bba3-b0ce-43f9-8fcc-77902aad1e3d |
| 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 | Broad Spectrum SPF45 |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Zinc Oxide, Octinoxate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | GEL |
| Route | TOPICAL |
| Active Ingredient Strength | 7.5; 12 |
| Active Ingredient Units | g/100g; g/100g |
| 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 39765-0035-01 (39765003501)
| NDC Package Code | 39765-035-01 |
|---|---|
| Billing NDC | 39765003501 |
| Package | 57 g in 1 BOTTLE (39765-035-01) |
| Marketing Start Date | 2020-01-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 66237771-bef5-4403-98cd-f0eb91f86e24 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, Cyclopentasiloxane, Niacinamide, Oleth-3 Phosphate, Octyldodecyl Neopentanoate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyisobutene, PEG-7 Trimethylolpropane Coconut Ether, Glycerin, Tocopheryl Acetate, Polygonum Aviculare Extract, Sodium Hyaluronate, Disodium EDTA, Sodium Hydroxide, Citric Acid, Phenoxyethanol, Ethylhexylglycerin, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Triethoxycaprylylsilane
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| BROAD SPECTRUM SPF45
zinc oxide, octinoxate gel |
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| Labeler - Neutraderm, Inc. (146224444) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Neutraderm, Inc. | 146224444 | manufacture(39765-035) | |