Home NDC 61016-0005 the Balm BalmShelter tinted moisturizer SPF 18 broad spectrum medium dark
Product NDC 61016-0005
11-digit product format 610160005
Labeler code 61016
Product ID 61016-0005_951cb4b7-01e6-31ee-e053-2995a90a149f
Type HUMAN OTC DRUG
Nonproprietary name OCTINOXATE, OCTISALATE, AVOBENZONE
Dosage form CREAM
Route TOPICAL
Labeler Columbia Cosmetics Manufacturing, Inc.
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2013-07-29
Marketing end 0000-00-00
Substance OCTINOXATE; OCTISALATE; AVOBENZONE
Active strength 75 mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2020-12-31
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 · 8 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 2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 61016-0005-0 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 61016-0005-0 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 61016-0005-0 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 61016-0005-0 bd6a592717d7…303034d00443…
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 AVOBENZONE ACTIVE INGREDIENT G63QQF2NOX THE BALM BALMSHELTER TINTED MOISTURIZER SPF 18 BROAD SPECTRUM MEDIUM DARK (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 1 OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 THE BALM BALMSHELTER TINTED MOISTURIZER SPF 18 BROAD SPECTRUM MEDIUM DARK (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 1 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W THE BALM BALMSHELTER TINTED MOISTURIZER SPF 18 BROAD SPECTRUM MEDIUM DARK (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 1 AVOBENZONE ACTIVE MOIETY G63QQF2NOX THE BALM BALMSHELTER TINTED MOISTURIZER SPF 18 BROAD SPECTRUM MEDIUM DARK (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 1 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 THE BALM BALMSHELTER TINTED MOISTURIZER SPF 18 BROAD SPECTRUM MEDIUM DARK (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 1 OCTISALATE ACTIVE MOIETY 4X49Y0596W THE BALM BALMSHELTER TINTED MOISTURIZER SPF 18 BROAD SPECTRUM MEDIUM DARK (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 1 CAPRYLYL GLYCOL INACTIVE INGREDIENT 00YIU5438U THE BALM BALMSHELTER TINTED MOISTURIZER SPF 18 BROAD SPECTRUM MEDIUM DARK (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 1 CETOSTEARYL ALCOHOL INACTIVE INGREDIENT 2DMT128M1S THE BALM BALMSHELTER TINTED MOISTURIZER SPF 18 BROAD SPECTRUM MEDIUM DARK (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 1 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O THE BALM BALMSHELTER TINTED MOISTURIZER SPF 18 BROAD SPECTRUM MEDIUM DARK (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 1 ETHYLHEXYLGLYCERIN INACTIVE INGREDIENT 147D247K3P THE BALM BALMSHELTER TINTED MOISTURIZER SPF 18 BROAD SPECTRUM MEDIUM DARK (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 THE BALM BALMSHELTER TINTED MOISTURIZER SPF 18 BROAD SPECTRUM MEDIUM DARK (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT THE BALM BALMSHELTER TINTED MOISTURIZER SPF 18 BROAD SPECTRUM MEDIUM DARK (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 THE BALM BALMSHELTER TINTED MOISTURIZER SPF 18 BROAD SPECTRUM MEDIUM DARK (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 1 HEXYL LAURATE INACTIVE INGREDIENT 4CG9F9W01Q THE BALM BALMSHELTER TINTED MOISTURIZER SPF 18 BROAD SPECTRUM MEDIUM DARK (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 1 HEXYLENE GLYCOL INACTIVE INGREDIENT KEH0A3F75J THE BALM BALMSHELTER TINTED MOISTURIZER SPF 18 BROAD SPECTRUM MEDIUM DARK (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 1 ISOHEXADECANE INACTIVE INGREDIENT 918X1OUF1E THE BALM BALMSHELTER TINTED MOISTURIZER SPF 18 BROAD SPECTRUM MEDIUM DARK (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 1 ISOPROPYL MYRISTATE INACTIVE INGREDIENT 0RE8K4LNJS THE BALM BALMSHELTER TINTED MOISTURIZER SPF 18 BROAD SPECTRUM MEDIUM DARK (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 1 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T THE BALM BALMSHELTER TINTED MOISTURIZER SPF 18 BROAD SPECTRUM MEDIUM DARK (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 1 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M THE BALM BALMSHELTER TINTED MOISTURIZER SPF 18 BROAD SPECTRUM MEDIUM DARK (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 1 POTASSIUM CETYL PHOSPHATE INACTIVE INGREDIENT 03KCY6P7UT THE BALM BALMSHELTER TINTED MOISTURIZER SPF 18 BROAD SPECTRUM MEDIUM DARK (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 1 SODIUM DEHYDROACETATE INACTIVE INGREDIENT 8W46YN971G THE BALM BALMSHELTER TINTED MOISTURIZER SPF 18 BROAD SPECTRUM MEDIUM DARK (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 1 SORBITAN SESQUIOLEATE INACTIVE INGREDIENT 0W8RRI5W5A THE BALM BALMSHELTER TINTED MOISTURIZER SPF 18 BROAD SPECTRUM MEDIUM DARK (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 1 STYRENE INACTIVE INGREDIENT 44LJ2U959V THE BALM BALMSHELTER TINTED MOISTURIZER SPF 18 BROAD SPECTRUM MEDIUM DARK (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP THE BALM BALMSHELTER TINTED MOISTURIZER SPF 18 BROAD SPECTRUM MEDIUM DARK (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R THE BALM BALMSHELTER TINTED MOISTURIZER SPF 18 BROAD SPECTRUM MEDIUM DARK (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [COLUMBIA COSMETICS MANUFACTURING, 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 61016-0005-0 61016000500 1 TUBE in 1 CARTON (61016-0005-0) > 64 mL in 1 TUBE 1 tube 2013-07-29 0000-00-00 No No Current