Home NDC 58443-0202-4 California Tan
Product NDC 58443-0202
Requested package NDC 58443-0202-4
11-digit product format 584430202
Labeler code 58443
Product ID 58443-0202_9c581ab7-5837-484b-e053-2a95a90a6e7b
Type HUMAN OTC DRUG
Nonproprietary name avobenzone, homosalate, octisalate, octocrylene and oxybenzone
Dosage form LOTION
Route TOPICAL
Labeler Prime Enterprises Inc.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2014-04-02
Marketing end 0000-00-00
Substance OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 20 mg/mL; mg/mL; 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 · 15 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…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58443-0202-4 California TanSPF 30 Sunscreen 133 mL in 1 BOTTLE LOTION 133 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AVOBENZONE ACTIVE INGREDIENT G63QQF2NOX CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 HOMOSALATE ACTIVE INGREDIENT V06SV4M95S CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 AVOBENZONE ACTIVE MOIETY G63QQF2NOX CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 HOMOSALATE ACTIVE MOIETY V06SV4M95S CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 OCTISALATE ACTIVE MOIETY 4X49Y0596W CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 (C10-C30)ALKYL METHACRYLATE ESTER INACTIVE INGREDIENT XH2FQZ38D8 CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 ADENOSINE CYCLIC PHOSPHATE INACTIVE INGREDIENT E0399OZS9N CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 ADENOSINE TRIPHOSPHATE INACTIVE INGREDIENT 8L70Q75FXE CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 ALPHA-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 AMINO ACIDS INACTIVE INGREDIENT 0O72R8RF8A CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 COLEUS FORSKOHLII ROOT OIL INACTIVE INGREDIENT 5NXR7DJ9WO CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 DEXTROSE INACTIVE INGREDIENT IY9XDZ35W2 CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 GREEN TEA LEAF INACTIVE INGREDIENT W2ZU1RY8B0 CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 HIGH DENSITY POLYETHYLENE INACTIVE INGREDIENT UG00KM4WR7 CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 ISOPROPYLPHTHALIMIDE INACTIVE INGREDIENT 1J1MM83329 CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 LYCIUM BARBARUM FRUIT INACTIVE INGREDIENT 930626MWDL CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 MICROCOCCUS LUTEUS INACTIVE INGREDIENT LV6L29Z6AX CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 N-BUTYLPHTHALIMIDE INACTIVE INGREDIENT 5TH1DKT35E CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 PHENYL TRIMETHICONE INACTIVE INGREDIENT DR0K5NOJ4R CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 POLYSILICONE-15 INACTIVE INGREDIENT F8DRP5BB29 CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 POTASSIUM CETYL PHOSPHATE INACTIVE INGREDIENT 03KCY6P7UT CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 PYRUVIC ACID INACTIVE INGREDIENT 8558G7RUTR CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 SACCHAROMYCES CEREVISIAE INACTIVE INGREDIENT 978D8U419H CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 SACCHAROMYCES LYSATE INACTIVE INGREDIENT R85W246Z1C CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 SOY PROTEIN INACTIVE INGREDIENT R44IWB3RN5 CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) INACTIVE INGREDIENT 5Z4DPO246A CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58443-0202 CALIFORNIA TAN SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 3 Legacy NDC, 1 package rows 20200118_2393ef7e-c7d8-07b4-e054-00144ff88e88.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58443-0202-4 58443020204 133 mL in 1 BOTTLE (58443-0202-4) 133 ml 2014-04-02 0000-00-00 No No Current