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NDC 58892-0348-45 CoTZ Face Prime and Protect SPF 40 (Non-Tinted) 80; 38 mg/g; mg/g Details
CoTZ Face Prime and Protect SPF 40 (Non-Tinted) 80; 38 mg/g; mg/g
CoTZ Face Prime and Protect SPF 40 (Non-Tinted) is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Fallien Cosmeceuticals, LTD. The primary component is TITANIUM DIOXIDE; ZINC OXIDE.
Product Information
NDC | 58892-0348 |
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Product ID | 58892-348_a4283ade-af62-4800-accf-3861b87629d8 |
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 | CoTZ Face Prime and Protect SPF 40 (Non-Tinted) |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Titanium Dioxide, Zinc Oxide |
Product Type | HUMAN OTC DRUG |
Dosage Form | CREAM |
Route | TOPICAL |
Active Ingredient Strength | 80; 38 |
Active Ingredient Units | mg/g; mg/g |
Substance Name | TITANIUM DIOXIDE; ZINC OXIDE |
Labeler Name | Fallien Cosmeceuticals, LTD |
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 58892-0348-45 (58892034845)
NDC Package Code | 58892-348-45 |
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Billing NDC | 58892034845 |
Package | 1 TUBE in 1 CARTON (58892-348-45) / 42.5 g in 1 TUBE |
Marketing Start Date | 2018-11-15 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL f106f52b-2157-46c7-9f7c-50f43a649050 Details
Uses:
Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings:
Directions:
- Apply liberally 15 minutes before sun exposure.
Reapply:
- -
- After 80 minutes of swimming or sweating
- -
- Immediately after towel drying
- -
- At least every two hours
- Children under 6 months: Ask a doctor
-
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 value of 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
Inactive Ingredients:
Other Information:
Principal Display Panel – 42.5 g Carton Label
INGREDIENTS AND APPEARANCE
COTZ FACE PRIME AND PROTECT SPF 40 (NON-TINTED)
titanium dioxide, zinc oxide cream |
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Labeler - Fallien Cosmeceuticals, LTD (958388357) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Custom Analytics LLC | 144949372 | ANALYSIS(58892-348) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Fragrance Manufacturing Inc. (FMI) | 793406000 | MANUFACTURE(58892-348) , PACK(58892-348) |
Revised: 6/2021
Document Id: a4283ade-af62-4800-accf-3861b87629d8
Set id: f106f52b-2157-46c7-9f7c-50f43a649050
Version: 1
Effective Time: 20210616