Home NDC 67879-301 DERMA FADE
Product NDC 67879-301
11-digit product format 678790301
Labeler code 67879
Product ID 67879-301_cf5c1e56-55ed-2997-e053-2a95a90ad26c
Type HUMAN OTC DRUG
Nonproprietary name OCTINOXATE, OCTISALATE, OXYBENZONE
Dosage form CREAM
Route TOPICAL
Labeler PHARMAGEL INTERNATIONAL INC
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2015-06-18
Marketing end 0000-00-00
Substance OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength 8 g/100g; g/100g; g/100g
NDC exclude flag No
Listing certified through 2022-12-31
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 · 22 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 67879-301-51 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 67879-301-51 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 67879-301-51 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 67879-301-51 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 67879-301-51 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 67879-301-51 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 67879-301-51 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 67879-301-51 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 67879-301-51 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 67879-301-51 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 67879-301-51 367a005e9d99…383a685ebd0f…
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 OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 OCTISALATE ACTIVE MOIETY 4X49Y0596W DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 ALLANTOIN INACTIVE INGREDIENT 344S277G0Z DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 BIOTIN INACTIVE INGREDIENT 6SO6U10H04 DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 BUTYLENE GLYCOL INACTIVE INGREDIENT 3XUS85K0RA DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 CAPRYLYL GLYCOL INACTIVE INGREDIENT 00YIU5438U DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) INACTIVE INGREDIENT 59TL3WG5CO DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 CETOSTEARYL ALCOHOL INACTIVE INGREDIENT 2DMT128M1S DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 CYPERUS ROTUNDUS TUBER INACTIVE INGREDIENT 4B51SRR959 DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 EDETATE SODIUM INACTIVE INGREDIENT MP1J8420LU DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 ETHYLHEXYL PALMITATE INACTIVE INGREDIENT 2865993309 DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 ETHYLHEXYLGLYCERIN INACTIVE INGREDIENT 147D247K3P DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 GLYCOLIC ACID INACTIVE INGREDIENT 0WT12SX38S DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 GLYCYRRHIZA GLABRA INACTIVE INGREDIENT 2788Z9758H DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 GREEN TEA LEAF INACTIVE INGREDIENT W2ZU1RY8B0 DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 HEXYLENE GLYCOL INACTIVE INGREDIENT KEH0A3F75J DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 HYDROXYETHYL CELLULOSE (3000 MPA.S AT 1%) INACTIVE INGREDIENT 7Q6P4JN1QT DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 KOJIC ACID INACTIVE INGREDIENT 6K23F1TT52 DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 LACTIC ACID INACTIVE INGREDIENT 33X04XA5AT DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 MAGNESIUM ASCORBYL PHOSPHATE INACTIVE INGREDIENT 0R822556M5 DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 MORUS ALBA LEAF INACTIVE INGREDIENT M8YIA49Q2P DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 MYRISTYL LAURATE INACTIVE INGREDIENT 58U0NZN2BT DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 MYRISTYL MYRISTATE INACTIVE INGREDIENT 4042ZC00DY DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 NIACIN INACTIVE INGREDIENT 2679MF687A DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 PANTHENOL INACTIVE INGREDIENT WV9CM0O67Z DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 PEG-100 STEARATE INACTIVE INGREDIENT YD01N1999R DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 PHYLLANTHUS EMBLICA FRUIT INACTIVE INGREDIENT YLX4CW2576 DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 TANGERINE PEEL INACTIVE INGREDIENT JU3D414057 DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 TROLAMINE INACTIVE INGREDIENT 9O3K93S3TK DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 UNDECYLENIC ACID INACTIVE INGREDIENT K3D86KJ24N DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 UNDECYLENOYL GLYCINE INACTIVE INGREDIENT 4D20464K2J DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R DERMA FADE (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [PHARMAGEL INTERNATIONAL INC] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67879-301-51 67879030151 1 JAR in 1 BOX (67879-301-51) > 56 g in 1 JAR (67879-301-11) 1 jar 2015-06-18 0000-00-00 No No Current