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NDC 63645-0183-01 SPF 45 - Lip Balm 30; 30; 75; 50; 400 mg/g; mg/g; mg/g; mg/g; mg/g Details
SPF 45 - Lip Balm 30; 30; 75; 50; 400 mg/g; mg/g; mg/g; mg/g; mg/g
SPF 45 - Lip Balm is a TOPICAL STICK in the HUMAN OTC DRUG category. It is labeled and distributed by OraLabs. The primary component is AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; PETROLATUM.
Product Information
| NDC | 63645-0183 |
|---|---|
| Product ID | 63645-183_afd10abe-1e8b-4df8-9d8c-ef15266c510c |
| 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 | SPF 45 - Lip Balm |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Avobenzone, Homosalate, Octinoxate, Octisalate, Petrolatum |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | STICK |
| Route | TOPICAL |
| Active Ingredient Strength | 30; 30; 75; 50; 400 |
| Active Ingredient Units | mg/g; mg/g; mg/g; mg/g; mg/g |
| Substance Name | AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; PETROLATUM |
| Labeler Name | OraLabs |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part352 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63645-0183-01 (63645018301)
| NDC Package Code | 63645-183-01 |
|---|---|
| Billing NDC | 63645018301 |
| Package | 4 g in 1 CONTAINER (63645-183-01) |
| Marketing Start Date | 2023-06-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |