NDC 67015-0033

EAU THERMALE Avene Hydrance Optimale Hydrating BROAD SPECTRUM SPF 25

Octinoxate, Octocrylene, Titanium Dioxide

EAU THERMALE Avene Hydrance Optimale Hydrating BROAD SPECTRUM SPF 25 is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Pierre Fabre Dermo-cosmetique Usa, Inc.. The primary component is Octinoxate; Octocrylene; Titanium Dioxide.

• Product ID: 67015-0033_14ab5e5e-e2ac-4b50-a768-81a139e456f9
• NDC: 67015-0033
• Product Type: Human Otc Drug
• Proprietary Name: EAU THERMALE Avene Hydrance Optimale Hydrating BROAD SPECTRUM SPF 25
• Generic Name: Octinoxate, Octocrylene, Titanium Dioxide
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2018-07-16
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part352
• Labeler Name: Pierre Fabre Dermo-Cosmetique USA, Inc.
• Substance Name: OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE
• Active Ingredient Strength: 75 mg/mL; mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 67015-0033-0

1 TUBE in 1 CARTON (67015-0033-0) > 40 mL in 1 TUBE

• Marketing Start Date: 2018-07-16
• Marketing End Date: 2022-04-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67015-0033-0 [67015003300]

EAU THERMALE Avene Hydrance Optimale Hydrating BROAD SPECTRUM SPF 25 CREAM

• Marketing Category: OTC monograph not final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-07-16

Drug Details

Active Ingredients

Ingredient	Strength
OCTINOXATE	75 mg/mL

OpenFDA Data

• SPL SET ID: 03417efd-941d-4ed7-9c9a-4b6183141ae7
• Manufacturer:
  • Pierre Fabre Dermo-Cosmetique USA, Inc.
• UNII:
  • 15FIX9V2JP
  • 5A68WGF6WM
  • 4Y5P7MUD51

NDC Crossover Matching brand name "EAU THERMALE Avene Hydrance Optimale Hydrating BROAD SPECTRUM SPF 25" or generic name "Octinoxate, Octocrylene, Titanium Dioxide"

NDC	Brand Name	Generic Name
67015-0033	EAU THERMALE Avene Hydrance Optimale Hydrating BROAD SPECTRUM SPF 25	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE
67225-5013	AGE 20s SIGNATURE ESSENCE COVER PACT INTENSE COVER 13 IVORY	Octinoxate, Octocrylene, Titanium Dioxide
67225-5021	AGE 20s SIGNATURE ESSENCE COVER PACT INTENSE COVER 21 LIGHT BEIGE	Octinoxate, Octocrylene, Titanium Dioxide
67225-5230	AGE 20s SIGNATURE ESSENCE COVER PACT INTENSE COVER 23 MEDIUM BEIGE	Octinoxate, Octocrylene, Titanium Dioxide
67225-5023	AGE 20s SIGNATURE ESSENCE COVER PACT INTENSE COVER 23 MEDIUM TAN	Octinoxate, Octocrylene, Titanium Dioxide
67225-5031	AGE 20s SIGNATURE ESSENCE COVER PACT INTENSE COVER 31 MEDIUM TAN	Octinoxate, Octocrylene, Titanium Dioxide
67225-2213	AGE 20s SIGNATURE ESSENCE COVER PACT LONG STAY 13 IVORY	Octinoxate, Octocrylene, Titanium Dioxide
67225-2221	AGE 20s SIGNATURE ESSENCE COVER PACT LONG STAY 21 LIGHT BEIGE	Octinoxate, Octocrylene, Titanium Dioxide
67225-2223	AGE 20s SIGNATURE ESSENCE COVER PACT LONG STAY 23 MEDIUM BEIGE	Octinoxate, Octocrylene, Titanium Dioxide
67225-2313	AGE 20s SIGNATURE ESSENCE COVER PACT MOISTURE 13 IVORY	Octinoxate, Octocrylene, Titanium Dioxide
67225-2321	AGE 20s SIGNATURE ESSENCE COVER PACT MOISTURE 21 LIGHT BEIGE	Octinoxate, Octocrylene, Titanium Dioxide
67225-2323	AGE 20s SIGNATURE ESSENCE COVER PACT MOISTURE 23 MEDIUM BEIGE	Octinoxate, Octocrylene, Titanium Dioxide