Home NDC 58443-0080-3 California Tan
Product NDC 58443-0080
Requested package NDC 58443-0080-3
11-digit product format 584430080
Labeler code 58443
Product ID 58443-0080_9c597550-4afb-876f-e053-2a95a90af2d8
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Octocrylene and Oxybenzone
Dosage form LOTION
Route TOPICAL
Labeler Prime Enterprises, Inc.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-12-09
Marketing end 0000-00-00
Substance AVOBENZONE; OCTOCRYLENE; OXYBENZONE
Active strength 5 mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2021-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 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 CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 AVOBENZONE ACTIVE MOIETY G63QQF2NOX CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 3-BUTYLPHTHALIDE INACTIVE INGREDIENT 822Q956KGM CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 ADENOSINE CYCLIC PHOSPHATE INACTIVE INGREDIENT E0399OZS9N CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 ADENOSINE TRIPHOSPHATE INACTIVE INGREDIENT 8L70Q75FXE CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 C12-15 ALKYL BENZOATE INACTIVE INGREDIENT A9EJ3J61HQ CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 CALCIUM INACTIVE INGREDIENT SY7Q814VUP CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) INACTIVE INGREDIENT 71DD5V995L CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 DEXTROSE INACTIVE INGREDIENT IY9XDZ35W2 CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 GREEN TEA LEAF INACTIVE INGREDIENT W2ZU1RY8B0 CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 HIGH DENSITY POLYETHYLENE INACTIVE INGREDIENT UG00KM4WR7 CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 ISOPROPYLPHTHALIMIDE INACTIVE INGREDIENT 1J1MM83329 CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 LYCIUM BARBARUM FRUIT INACTIVE INGREDIENT 930626MWDL CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 MAGNESIUM INACTIVE INGREDIENT I38ZP9992A CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 METHYLISOTHIAZOLINONE INACTIVE INGREDIENT 229D0E1QFA CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OMEGA-3 FATTY ACIDS INACTIVE INGREDIENT 71M78END5S CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 PHENYL TRIMETHICONE INACTIVE INGREDIENT DR0K5NOJ4R CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 POLYSILICONE-15 INACTIVE INGREDIENT F8DRP5BB29 CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 POTASSIUM CETYL PHOSPHATE INACTIVE INGREDIENT 03KCY6P7UT CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 PYRUVIC ACID INACTIVE INGREDIENT 8558G7RUTR CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 SACCHAROMYCES LYSATE INACTIVE INGREDIENT R85W246Z1C CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 SOY PROTEIN INACTIVE INGREDIENT R44IWB3RN5 CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 STYRENE INACTIVE INGREDIENT 44LJ2U959V CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 ZINC INACTIVE INGREDIENT J41CSQ7QDS CALIFORNIA TAN BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES, 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 58443-0080-3 58443008003 133 mL in 1 TUBE (58443-0080-3) 133 ml 2013-12-09 0000-00-00 No No Current