Home NDC 61016-0002 Antioxidant Day SPF 15
Product NDC 61016-0002
11-digit product format 610160002
Labeler code 61016
Product ID 61016-0002_cf47b4fc-c0d2-65f4-e053-2995a90a8885
Type HUMAN OTC DRUG
Nonproprietary name OCTINOXATE, OCTISALATE, OXYBENZONE
Dosage form CREAM
Route TOPICAL
Labeler Columbia Cosmetics Manufacturing, Inc.
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2012-04-19
Marketing end 0000-00-00
Substance OCTISALATE; OCTINOXATE; OXYBENZONE
Active strength 30 mg/mL; mg/mL; mg/mL
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 61016-0002 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 61016-0002 61016-0002-2 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 ANTIOXIDANT DAY SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 2 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W ANTIOXIDANT DAY SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 2 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y ANTIOXIDANT DAY SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 2 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 ANTIOXIDANT DAY SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 2 OCTISALATE ACTIVE MOIETY 4X49Y0596W ANTIOXIDANT DAY SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 2 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y ANTIOXIDANT DAY SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 2 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 ANTIOXIDANT DAY SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 2 ALLANTOIN INACTIVE INGREDIENT 344S277G0Z ANTIOXIDANT DAY SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 2 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X ANTIOXIDANT DAY SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 2 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R ANTIOXIDANT DAY SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 2 ASCORBYL PALMITATE INACTIVE INGREDIENT QN83US2B0N ANTIOXIDANT DAY SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 2 BUTYLENE GLYCOL INACTIVE INGREDIENT 3XUS85K0RA ANTIOXIDANT DAY SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 2 CAPRYLYL GLYCOL INACTIVE INGREDIENT 00YIU5438U ANTIOXIDANT DAY SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP ANTIOXIDANT DAY SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 2 CYCLOMETHICONE 5 INACTIVE INGREDIENT 0THT5PCI0R ANTIOXIDANT DAY SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 2 CYCLOMETHICONE 6 INACTIVE INGREDIENT XHK3U310BA ANTIOXIDANT DAY SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 2 ETHYLHEXYLGLYCERIN INACTIVE INGREDIENT 147D247K3P ANTIOXIDANT DAY SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ANTIOXIDANT DAY SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 2 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 ANTIOXIDANT DAY SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 2 HEXYLENE GLYCOL INACTIVE INGREDIENT KEH0A3F75J ANTIOXIDANT DAY SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 2 MAGNESIUM ALUMINUM SILICATE INACTIVE INGREDIENT 6M3P64V0NC ANTIOXIDANT DAY SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 2 PANTHENOL INACTIVE INGREDIENT WV9CM0O67Z ANTIOXIDANT DAY SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 2 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T ANTIOXIDANT DAY SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ ANTIOXIDANT DAY SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 2 POLYOXYL 20 CETOSTEARYL ETHER INACTIVE INGREDIENT YRC528SWUY ANTIOXIDANT DAY SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 2 POTASSIUM CETYL PHOSPHATE INACTIVE INGREDIENT 03KCY6P7UT ANTIOXIDANT DAY SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ANTIOXIDANT DAY SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I ANTIOXIDANT DAY SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 2 SORBITAN MONOSTEARATE INACTIVE INGREDIENT NVZ4I0H58X ANTIOXIDANT DAY SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 2 SQUALANE INACTIVE INGREDIENT GW89575KF9 ANTIOXIDANT DAY SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ANTIOXIDANT DAY SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 2 TOCOPHEROL INACTIVE INGREDIENT R0ZB2556P8 ANTIOXIDANT DAY SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 2 VITAMIN A PALMITATE INACTIVE INGREDIENT 1D1K0N0VVC ANTIOXIDANT DAY SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R ANTIOXIDANT DAY SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 61016-0002-2 61016000202 59 mL in 1 BOTTLE (61016-0002-2) 59 ml 2012-04-19 0000-00-00 No No Current