Home NDC 67015-0791 Eau Thermale Avene Hydrating Sunscreen SPF 50
Product NDC 67015-0791
11-digit product format 670150791
Labeler code 67015
Product ID 67015-0791_923580c7-e63d-4aa7-e053-2995a90a3c3b
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, Octocrylene
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 2020-01-01
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 30 mg/mL; mg/mL; 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 67015-0791-1 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 67015-0791-1 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 67015-0791-1 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 67015-0791-1 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 67015-0791-1 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 67015-0791-1 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 67015-0791-1 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 67015-0791-1 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 67015-0791-1 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 67015-0791-1 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 67015-0791-1 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 67015-0791-1 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 AVOBENZONE ACTIVE INGREDIENT G63QQF2NOX EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 HOMOSALATE ACTIVE INGREDIENT V06SV4M95S EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 AVOBENZONE ACTIVE MOIETY G63QQF2NOX EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 HOMOSALATE ACTIVE MOIETY V06SV4M95S EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 OCTISALATE ACTIVE MOIETY 4X49Y0596W EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 ARACHIDYL ALCOHOL INACTIVE INGREDIENT 1QR1QRA9BU EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 ARACHIDYL GLUCOSIDE INACTIVE INGREDIENT 6JVW35JOOJ EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER INACTIVE INGREDIENT V5RS026Q0H EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 CETYL DIMETHICONE 25 INACTIVE INGREDIENT U4AS1BW4ZB EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 DOCOSANOL INACTIVE INGREDIENT 9G1OE216XY EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 ETHYLHEXYL METHOXYCRYLENE INACTIVE INGREDIENT S3KFG6Q5X8 EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 ETHYLHEXYLGLYCERIN INACTIVE INGREDIENT 147D247K3P EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 ISODODECANE INACTIVE INGREDIENT A8289P68Y2 EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 ISOHEXADECANE INACTIVE INGREDIENT 918X1OUF1E EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 ISONONYL ISONONANOATE INACTIVE INGREDIENT S4V5BS6GCX EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 NEOPENTYL GLYCOL DIHEPTANOATE INACTIVE INGREDIENT 5LKW3C543X EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 OLEIC ACID INACTIVE INGREDIENT 2UMI9U37CP EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 P-ANISIC ACID INACTIVE INGREDIENT 4SB6Y7DMM3 EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 POLYESTER-7 INACTIVE INGREDIENT 0841698D2F EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) INACTIVE INGREDIENT T9296U138P EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 POLYGLYCERYL-3 DISTEARATE INACTIVE INGREDIENT ZI1LK470XV EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 SODIUM POLYACRYLATE (8000 MW) INACTIVE INGREDIENT 285CYO341L EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 SORBITAN ISOSTEARATE INACTIVE INGREDIENT 01S2G2C1E4 EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 STEARETH-100 INACTIVE INGREDIENT 4OH5W9UM87 EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 STEARETH-2 INACTIVE INGREDIENT V56DFE46J5 EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1 YEAST MANNAN INACTIVE INGREDIENT 91R887N59P EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PIERRE FABRE DERMO-COSMETIQUE USA, INC.] 1