Pacifica CC broad spectrum SPF 17 MEDIUM

Product NDC: 61197-001
11-digit product format: 611970001
Labeler code: 61197
Product ID: 61197-001_995b6573-27fe-2773-e053-2a95a90a90af
Type: HUMAN OTC DRUG
Nonproprietary name: ZINC OXIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: Pacifica Beauty, LLC
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2013-11-21
Marketing end: 0000-00-00
Substance: ZINC OXIDE
Active strength: 114 mg/mL
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	61197-001		I	Inactivated by FDA		2026-10-15
excluded package	package	61197-001	61197-001-00	I	Inactivated by FDA		2026-10-15

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 · 30 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61197-001-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61197-001-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61197-001-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61197-001-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61197-001-00	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61197-001-00	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61197-001-00	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61197-001-00	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61197-001-00	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61197-001-00	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61197-001-00	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61197-001-00	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61197-001-00	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61197-001-00	`834df4deac94…`	`adcc014656a3…`
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	61197-001-00	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61197-001-00	2023-01-30	C162847	48780-1	f386c649-e8ec-0266-e053-dadaa90a7c1a	Pacifica CC+ CREAM broad spectrum SPF 17 MEDIUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61197-001-00	Pacifica CC broad spectrum SPF 17 MEDIUM	1 in 1 BOX	CREAM	1		3
61197-001-00	Pacifica CC broad spectrum SPF 17 MEDIUM	30 mL in 1 BOTTLE, PUMP	CREAM	30		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	PACIFICA CC BROAD SPECTRUM SPF 17 MEDIUM (ZINC OXIDE) CREAM [PACIFICA INC.]	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	PACIFICA CC BROAD SPECTRUM SPF 17 MEDIUM (ZINC OXIDE) CREAM [PACIFICA INC.]	1
.ALPHA.-AMYLCINNAMALDEHYDE	INACTIVE INGREDIENT	WC51CA3418	PACIFICA CC BROAD SPECTRUM SPF 17 MEDIUM (ZINC OXIDE) CREAM [PACIFICA INC.]	1
CETEARYL OLIVATE	INACTIVE INGREDIENT	58B69Q84JO	PACIFICA CC BROAD SPECTRUM SPF 17 MEDIUM (ZINC OXIDE) CREAM [PACIFICA INC.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	PACIFICA CC BROAD SPECTRUM SPF 17 MEDIUM (ZINC OXIDE) CREAM [PACIFICA INC.]	1
COCONUT JUICE	INACTIVE INGREDIENT	AMN6S4M09G	PACIFICA CC BROAD SPECTRUM SPF 17 MEDIUM (ZINC OXIDE) CREAM [PACIFICA INC.]	1
ETHYL JOJOBATE	INACTIVE INGREDIENT	2351QH8W1N	PACIFICA CC BROAD SPECTRUM SPF 17 MEDIUM (ZINC OXIDE) CREAM [PACIFICA INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	PACIFICA CC BROAD SPECTRUM SPF 17 MEDIUM (ZINC OXIDE) CREAM [PACIFICA INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PACIFICA CC BROAD SPECTRUM SPF 17 MEDIUM (ZINC OXIDE) CREAM [PACIFICA INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PACIFICA CC BROAD SPECTRUM SPF 17 MEDIUM (ZINC OXIDE) CREAM [PACIFICA INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PACIFICA CC BROAD SPECTRUM SPF 17 MEDIUM (ZINC OXIDE) CREAM [PACIFICA INC.]	1
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	PACIFICA CC BROAD SPECTRUM SPF 17 MEDIUM (ZINC OXIDE) CREAM [PACIFICA INC.]	1
MACROCYSTIS PYRIFERA	INACTIVE INGREDIENT	K31S3OG5C4	PACIFICA CC BROAD SPECTRUM SPF 17 MEDIUM (ZINC OXIDE) CREAM [PACIFICA INC.]	1
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	PACIFICA CC BROAD SPECTRUM SPF 17 MEDIUM (ZINC OXIDE) CREAM [PACIFICA INC.]	1
MICA	INACTIVE INGREDIENT	V8A1AW0880	PACIFICA CC BROAD SPECTRUM SPF 17 MEDIUM (ZINC OXIDE) CREAM [PACIFICA INC.]	1
POTASSIUM CETYL PHOSPHATE	INACTIVE INGREDIENT	03KCY6P7UT	PACIFICA CC BROAD SPECTRUM SPF 17 MEDIUM (ZINC OXIDE) CREAM [PACIFICA INC.]	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	PACIFICA CC BROAD SPECTRUM SPF 17 MEDIUM (ZINC OXIDE) CREAM [PACIFICA INC.]	1
SAFFLOWER OIL	INACTIVE INGREDIENT	65UEH262IS	PACIFICA CC BROAD SPECTRUM SPF 17 MEDIUM (ZINC OXIDE) CREAM [PACIFICA INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PACIFICA CC BROAD SPECTRUM SPF 17 MEDIUM (ZINC OXIDE) CREAM [PACIFICA INC.]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	PACIFICA CC BROAD SPECTRUM SPF 17 MEDIUM (ZINC OXIDE) CREAM [PACIFICA INC.]	1
SODIUM DEHYDROACETATE	INACTIVE INGREDIENT	8W46YN971G	PACIFICA CC BROAD SPECTRUM SPF 17 MEDIUM (ZINC OXIDE) CREAM [PACIFICA INC.]	1
SORBITAN OLIVATE	INACTIVE INGREDIENT	MDL271E3GR	PACIFICA CC BROAD SPECTRUM SPF 17 MEDIUM (ZINC OXIDE) CREAM [PACIFICA INC.]	1
SORBITAN SESQUIOLEATE	INACTIVE INGREDIENT	0W8RRI5W5A	PACIFICA CC BROAD SPECTRUM SPF 17 MEDIUM (ZINC OXIDE) CREAM [PACIFICA INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PACIFICA CC BROAD SPECTRUM SPF 17 MEDIUM (ZINC OXIDE) CREAM [PACIFICA INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PACIFICA CC BROAD SPECTRUM SPF 17 MEDIUM (ZINC OXIDE) CREAM [PACIFICA INC.]	1
WITHANIA SOMNIFERA ROOT	INACTIVE INGREDIENT	V038D626IF	PACIFICA CC BROAD SPECTRUM SPF 17 MEDIUM (ZINC OXIDE) CREAM [PACIFICA INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61197-001	PACIFICA CC BROAD SPECTRUM SPF 17 MEDIUM (ZINC OXIDE) CREAM [PACIFICA BEAUTY, LLC]	3	Legacy NDC, 2 package rows	20191211_3336d676-5ad9-4f8e-bb71-fa14a6b3e252.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61197-001-00	61197000100	1 BOTTLE, PUMP in 1 BOX (61197-001-00) > 30 mL in 1 BOTTLE, PUMP	2013-11-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pacifica CC+ CREAM broad spectrum SPF 17 MEDIUM	Pacifica Beauty, LLC \| Columbia Cosmetics Manufacturing, Inc.	2019-12-10	HUMAN OTC DRUG LABEL	3