Home NDC 67015-0784 Eau Thermale Avene Mineral Ultra-Light Hydrating Sunscreen SPF 50
Product NDC 67015-0784
11-digit product format 670150784
Labeler code 67015
Product ID 67015-0784_92358453-405e-5b9c-e053-2a95a90ac524
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler Pierre Fabre Dermo-Cosmetique USA, Inc.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-03-06
Marketing end 2020-04-01
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 40 mg/mL; mg/mL
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 67015-0784-1 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 67015-0784-1 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 67015-0784-1 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 67015-0784-1 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 67015-0784-1 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 67015-0784-1 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 67015-0784-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 67015-0784-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 67015-0784-1 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 67015-0784-1 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 67015-0784-1 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 67015-0784-1 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TITANIUM DIOXIDE ACTIVE INGREDIENT 15FIX9V2JP EAU THERMALE AVENE MINERAL ULTRA-LIGHT HYDRATING SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 2 ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z EAU THERMALE AVENE MINERAL ULTRA-LIGHT HYDRATING SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 2 TITANIUM DIOXIDE ACTIVE MOIETY 15FIX9V2JP EAU THERMALE AVENE MINERAL ULTRA-LIGHT HYDRATING SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 2 ZINC OXIDE ACTIVE MOIETY SOI2LOH54Z EAU THERMALE AVENE MINERAL ULTRA-LIGHT HYDRATING SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 2 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 EAU THERMALE AVENE MINERAL ULTRA-LIGHT HYDRATING SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 2 ALKYL (C12-15) BENZOATE INACTIVE INGREDIENT A9EJ3J61HQ EAU THERMALE AVENE MINERAL ULTRA-LIGHT HYDRATING SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 2 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 EAU THERMALE AVENE MINERAL ULTRA-LIGHT HYDRATING SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 2 BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER INACTIVE INGREDIENT 7K68DGG29P EAU THERMALE AVENE MINERAL ULTRA-LIGHT HYDRATING SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 2 BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER INACTIVE INGREDIENT V5RS026Q0H EAU THERMALE AVENE MINERAL ULTRA-LIGHT HYDRATING SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 2 BUTYLENE GLYCOL INACTIVE INGREDIENT 3XUS85K0RA EAU THERMALE AVENE MINERAL ULTRA-LIGHT HYDRATING SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 2 BUTYLOCTYL SALICYLATE INACTIVE INGREDIENT 2EH13UN8D3 EAU THERMALE AVENE MINERAL ULTRA-LIGHT HYDRATING SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 2 CETYL DIMETHICONE 150 INACTIVE INGREDIENT 5L694Y0T22 EAU THERMALE AVENE MINERAL ULTRA-LIGHT HYDRATING SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 2 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O EAU THERMALE AVENE MINERAL ULTRA-LIGHT HYDRATING SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 2 DIMETHICONE PEG-8 LAURATE INACTIVE INGREDIENT 72MF9C2A18 EAU THERMALE AVENE MINERAL ULTRA-LIGHT HYDRATING SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 2 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K EAU THERMALE AVENE MINERAL ULTRA-LIGHT HYDRATING SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 2 ETHYLHEXYLGLYCERIN INACTIVE INGREDIENT 147D247K3P EAU THERMALE AVENE MINERAL ULTRA-LIGHT HYDRATING SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX EAU THERMALE AVENE MINERAL ULTRA-LIGHT HYDRATING SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 2 HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) INACTIVE INGREDIENT 86FQE96TZ4 EAU THERMALE AVENE MINERAL ULTRA-LIGHT HYDRATING SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 2 ISOSTEARIC ACID INACTIVE INGREDIENT X33R8U0062 EAU THERMALE AVENE MINERAL ULTRA-LIGHT HYDRATING SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 2 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 EAU THERMALE AVENE MINERAL ULTRA-LIGHT HYDRATING SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 2 METHICONE (20 CST) INACTIVE INGREDIENT 6777U11MKT EAU THERMALE AVENE MINERAL ULTRA-LIGHT HYDRATING SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 2 OCTYLDODECYL NEOPENTANOATE INACTIVE INGREDIENT X8725R883T EAU THERMALE AVENE MINERAL ULTRA-LIGHT HYDRATING SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 2 OLEIC ACID INACTIVE INGREDIENT 2UMI9U37CP EAU THERMALE AVENE MINERAL ULTRA-LIGHT HYDRATING SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 2 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T EAU THERMALE AVENE MINERAL ULTRA-LIGHT HYDRATING SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 2 POLY(METHYL METHACRYLATE; 450000 MW) INACTIVE INGREDIENT Z47NNT4J11 EAU THERMALE AVENE MINERAL ULTRA-LIGHT HYDRATING SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 2 POLYHYDROXYSTEARIC ACID (2300 MW) INACTIVE INGREDIENT YXH47AOU0F EAU THERMALE AVENE MINERAL ULTRA-LIGHT HYDRATING SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 2 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X EAU THERMALE AVENE MINERAL ULTRA-LIGHT HYDRATING SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R EAU THERMALE AVENE MINERAL ULTRA-LIGHT HYDRATING SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 2 TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) INACTIVE INGREDIENT 25LXE464L2 EAU THERMALE AVENE MINERAL ULTRA-LIGHT HYDRATING SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 2 TRISILOXANE INACTIVE INGREDIENT 9G1ZW13R0G EAU THERMALE AVENE MINERAL ULTRA-LIGHT HYDRATING SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R EAU THERMALE AVENE MINERAL ULTRA-LIGHT HYDRATING SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 2 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE EAU THERMALE AVENE MINERAL ULTRA-LIGHT HYDRATING SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 2