California Tan

Product NDC: 58443-0097
Requested package NDC: 58443-0097-3
11-digit product format: 584430097
Labeler code: 58443
Product ID: 58443-0097_9c59712e-ed48-fa1c-e053-2995a90a0223
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: 2013-04-04
Marketing end: 0000-00-00
Substance: AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength: 30 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	58443-0097	58443-0097-3	I	Inactivated by FDA		2026-10-05

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#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ef9a935e-31b7-402c-a66c-716cdfe4f126	Product name	9	20241218
115c5bd2-98e1-4a98-8292-90803ca7e851	Product name	1	20220127
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58443-0097-3	2024-01-30	C162847	48780-1	1030e365-3974-111a-e063-dadaa90a10e2	8ea7a7d5-4c8b-402f-91a3-165567a484e4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58443-0097-3	California TanBROAD SPECTRUM SPF 45	133 mL in 1 TUBE	LOTION	133		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
HOMOSALATE	ACTIVE INGREDIENT	V06SV4M95S	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
HOMOSALATE	ACTIVE MOIETY	V06SV4M95S	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
3-BUTYLPHTHALIDE	INACTIVE INGREDIENT	822Q956KGM	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
ADENOSINE CYCLIC PHOSPHATE	INACTIVE INGREDIENT	E0399OZS9N	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
ADENOSINE TRIPHOSPHATE	INACTIVE INGREDIENT	8L70Q75FXE	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
AMINO ACIDS	INACTIVE INGREDIENT	0O72R8RF8A	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
CALCIUM	INACTIVE INGREDIENT	SY7Q814VUP	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	71DD5V995L	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
HIGH DENSITY POLYETHYLENE	INACTIVE INGREDIENT	UG00KM4WR7	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
ISOPROPYLPHTHALIMIDE	INACTIVE INGREDIENT	1J1MM83329	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
LYCIUM BARBARUM FRUIT	INACTIVE INGREDIENT	930626MWDL	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
MAGNESIUM	INACTIVE INGREDIENT	I38ZP9992A	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
OMEGA-3 FATTY ACIDS	INACTIVE INGREDIENT	71M78END5S	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
PHENYL TRIMETHICONE	INACTIVE INGREDIENT	DR0K5NOJ4R	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
PLECTRANTHUS BARBATUS ROOT	INACTIVE INGREDIENT	V5741391RG	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
POLYSILICONE-15	INACTIVE INGREDIENT	F8DRP5BB29	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
POTASSIUM CETYL PHOSPHATE	INACTIVE INGREDIENT	03KCY6P7UT	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
PYRUVIC ACID	INACTIVE INGREDIENT	8558G7RUTR	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
SACCHAROMYCES LYSATE	INACTIVE INGREDIENT	R85W246Z1C	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
SOY PROTEIN	INACTIVE INGREDIENT	R44IWB3RN5	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
STYRENE	INACTIVE INGREDIENT	44LJ2U959V	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	1
ZINC	INACTIVE INGREDIENT	J41CSQ7QDS	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (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
58443-0097	CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]	4	Legacy NDC, 1 package rows	20200118_8ea7a7d5-4c8b-402f-91a3-165567a484e4.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58443-0097-3	58443009703	133 mL in 1 TUBE (58443-0097-3)	133 ml	2013-04-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
California Tan BROAD SPECTRUM SPF 45 - Prime Enterprises, Inc.	Prime Enterprises, Inc.	2020-01-17	HUMAN OTC DRUG LABEL	4