Safe Harbor Natural Suncare

Product NDC: 42421-575
11-digit product format: 424210575
Labeler code: 42421
Product ID: 42421-575_457b8d97-15ee-44eb-a985-b6e69e1ad1d3
Type: HUMAN OTC DRUG
Nonproprietary name: TITANIUM DIOXIDE, ZINC OXIDE
Dosage form: LOTION
Route: TOPICAL
Labeler: Emilia Personal Care Inc
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2015-11-15
Marketing end: 0000-00-00
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 9 g/124g; g/124g
NDC exclude flag: No
Listing certified through: 2019-12-31
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	42421-575		I	Inactivated by FDA		2026-10-05
excluded package	package	42421-575	42421-575-15	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 · 42 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	42421-575-15	`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	42421-575-15	`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	42421-575-15	`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	42421-575-15	`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	42421-575-15	`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	42421-575-15	`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	42421-575-15	`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	42421-575-15	`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	42421-575-15	`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	42421-575-15	`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	42421-575-15	`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	42421-575-15	`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	42421-575-15	`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	42421-575-15	`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	42421-575-15	`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	42421-575-15	`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	42421-575-15	`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	42421-575-15	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	42421-575-15	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	42421-575-15	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	42421-575-15	`9bebd1f3094a…`	`5416666fcb17…`

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
42421-575-15	2020-01-31	C162847	48780-1	9d75b9d0-535f-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42421-575-15	Safe Harbor Natural SuncareBroad Spectrum	124 g in 1 TUBE	LOTION	124		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]	1
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]	1
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]	1
ASPALATHUS LINEARIS LEAF	INACTIVE INGREDIENT	H7UGK1GJCU	SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]	1
CETEARYL GLUCOSIDE	INACTIVE INGREDIENT	09FUA47KNA	SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]	1
ECHINACEA PURPUREA ROOT	INACTIVE INGREDIENT	OS64WTR4KU	SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]	1
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]	1
GLYCERYL 1-STEARATE	INACTIVE INGREDIENT	258491E1RZ	SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]	1
HIPPOPHAE RHAMNOIDES SEED OIL	INACTIVE INGREDIENT	T53SBG6741	SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]	1
JOJOBA OIL	INACTIVE INGREDIENT	724GKU717M	SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]	1
LEVOMENOL	INACTIVE INGREDIENT	24WE03BX2T	SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]	1
MATRICARIA RECUTITA ROOT	INACTIVE INGREDIENT	BTG5H50X7F	SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]	1
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]	1
MELISSA OFFICINALIS LEAF	INACTIVE INGREDIENT	50D2ZE9219	SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]	1
OAT	INACTIVE INGREDIENT	Z6J799EAJK	SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]	1
PANTHENOL	INACTIVE INGREDIENT	WV9CM0O67Z	SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]	1
PEG-40 STEARATE	INACTIVE INGREDIENT	ECU18C66Q7	SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]	1
POTASSIUM CETYL PHOSPHATE	INACTIVE INGREDIENT	03KCY6P7UT	SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]	1
SESAME OIL	INACTIVE INGREDIENT	QX10HYY4QV	SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]	1
SHEA BUTTER	INACTIVE INGREDIENT	K49155WL9Y	SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]	1
TILIA X EUROPAEA FLOWER	INACTIVE INGREDIENT	NHV2K1OUDH	SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]	1
TRIMETHOXYCAPRYLYLSILANE	INACTIVE INGREDIENT	FZ07E4LW2M	SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42421-575	SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]	1	Legacy NDC, 1 package rows	20151121_ae98d652-b2c8-4c81-a126-e054d6b8eb88.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
42421-575-15	42421057515	124 g in 1 TUBE	124 g	Historical