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 ID67015-0033_14ab5e5e-e2ac-4b50-a768-81a139e456f9
NDC67015-0033
Product TypeHuman Otc Drug
Proprietary NameEAU THERMALE Avene Hydrance Optimale Hydrating BROAD SPECTRUM SPF 25
Generic NameOctinoxate, Octocrylene, Titanium Dioxide
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2018-07-16
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NamePierre Fabre Dermo-Cosmetique USA, Inc.
Substance NameOCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE
Active Ingredient Strength75 mg/mL; mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 67015-0033-0

1 TUBE in 1 CARTON (67015-0033-0) > 40 mL in 1 TUBE
Marketing Start Date2018-07-16
Marketing End Date2022-04-30
NDC Exclude FlagN
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 CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-07-16

Drug Details

Active Ingredients

IngredientStrength
OCTINOXATE75 mg/mL

OpenFDA Data

SPL SET ID:03417efd-941d-4ed7-9c9a-4b6183141ae7
Manufacturer
UNII

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

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

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