Gr Bb Spf 25 Cream
NDC Package 82715-101-06

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Package Information
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Frequently Asked Questions

Package Information

Gr Bb Spf 25 (octinoxate, oxybenzone, titanium dioxide) cream is • apply generously 15 minutes before the sun exposure • apply to cleansed skin • can be applied two coats to increase coverage • reapply at least every 2 hours • use a water resistant sunscreen if swimming or sweating• Sun Protection Measures. This formulation utilizes a cream delivery system. Marketed by Erkul Kozmetik Sanayi Ve Ticaret Anonim Sirketi, this product is identified by NDC 82715-101 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code

82715-101-06

Package Description

1 TUBE in 1 CARTON / 30 mL in 1 TUBE

Product Code

82715-101

11-Digit Billing Format

82715010106

Clinical Specifications

Proprietary Name

Gr Bb Spf 25

Non-Proprietary Name

Octinoxate, Oxybenzone, Titanium Dioxide

Substance Name

Octinoxate; Oxybenzone; Titanium Dioxide

Dosage Form

Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Administration Route

Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Active Ingredient(s)

Usage Information

• apply generously 15 minutes before the sun exposure • apply to cleansed skin • can be applied two coats to increase coverage • reapply at least every 2 hours • use a water resistant sunscreen if swimming or sweating• 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 sun Broad Spectrum SPF value of 15 or higher and other 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 doctor

Regulatory & Marketing

Labeler Name

Erkul Kozmetik Sanayi Ve Ticaret Anonim Sirketi

Product Type

Human Otc Drug

FDA Application #

M020

Marketing Category

OTC MONOGRAPH DRUG -

Start Marketing Date

06-06-2022

End Marketing Date

06-30-2029

Exclude Flag

Sample Package

Hierarchy Structure

Code Lineage

82715 - Erkul Kozmetik Sanayi Ve Ticaret Anonim Sirketi
- 82715-101 - Gr Bb Spf 25
  - 82715-101-06 - 1 TUBE in 1 CARTON / 30 mL in 1 TUBE

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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Other Available Packages

The following commercial packages are registered under the same Product NDC (82715-101). Click a package code to view its specific billing and regulatory data.

82715-101-01