SMOOTHING MINERAL PRIMER

Product NDC: 69863-101
11-digit product format: 698630101
Labeler code: 69863
Product ID: 69863-101_99f8dd9f-b9d2-4169-abe8-71850527fab1
Type: HUMAN OTC DRUG
Nonproprietary name: TITANIUM DIOXIDE
Dosage form: LOTION
Route: TOPICAL
Labeler: HATCHBEAUTY PRODUCTS LLC
Application: part352
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2015-06-18
Marketing end: 0000-00-00
Substance: TITANIUM DIOXIDE
Active strength: 7 g/100mL
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	69863-101		I	Inactivated by FDA	2026-10-12
excluded package	package	69863-101	69863-101-12	I	Inactivated by FDA	2026-10-12
excluded package	package	69863-101	69863-101-13	I	Inactivated by FDA	2026-10-12
excluded package	package	69863-101	69863-101-51	I	Inactivated by FDA	2026-10-12

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 2 · 88 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	69863-101-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69863-101-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69863-101-51	`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	69863-101-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69863-101-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69863-101-51	`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	69863-101-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69863-101-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69863-101-51	`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	69863-101-13	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69863-101-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69863-101-51	`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	69863-101-13	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69863-101-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69863-101-51	`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	69863-101-13	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69863-101-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69863-101-51	`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	69863-101-13	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69863-101-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69863-101-51	`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	69863-101-13	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69863-101-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69863-101-51	`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	69863-101-13	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69863-101-12	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69863-101-51	`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	69863-101-13	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69863-101-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69863-101-51	`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	69863-101-13	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69863-101-12	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69863-101-51	`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	69863-101-13	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69863-101-12	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69863-101-51	`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	69863-101-13	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69863-101-12	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69863-101-51	`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	69863-101-13	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69863-101-12	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69863-101-51	`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	69863-101-13	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69863-101-12	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69863-101-51	`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
69863-101-12	2020-01-31	C162847	48780-1	9d75b9cf-fb12-f424-e053-dadaa90a57ce	ec3bea36-644d-4263-970c-5e001a257fc7
69863-101-13	2020-01-31	C162847	48780-1	9d75b9cf-fb12-f424-e053-dadaa90a57ce	ec3bea36-644d-4263-970c-5e001a257fc7
69863-101-51	2020-01-31	C162847	48780-1	9d75b9cf-fb12-f424-e053-dadaa90a57ce	ec3bea36-644d-4263-970c-5e001a257fc7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69863-101-11	SMOOTHING MINERAL PRIMERSPF-15	30 mL in 1 BOTTLE, PUMP	LOTION	30	4
69863-101-12	SMOOTHING MINERAL PRIMERSPF-15	5 mL in 1 TUBE	LOTION	5	4
69863-101-13	SMOOTHING MINERAL PRIMERSPF-15	7 mL in 1 TUBE	LOTION	7	4
69863-101-51	SMOOTHING MINERAL PRIMERSPF-15	1 in 1 BOX	LOTION	1	4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	SMOOTHING MINERAL PRIMER SPF-15 (TITANIUM DIOXIDE) LOTION [HATCHBEAUTY PRODUCTS LLC]	2
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	SMOOTHING MINERAL PRIMER SPF-15 (TITANIUM DIOXIDE) LOTION [HATCHBEAUTY PRODUCTS LLC]	2
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	SMOOTHING MINERAL PRIMER SPF-15 (TITANIUM DIOXIDE) LOTION [HATCHBEAUTY PRODUCTS LLC]	2
AMARANTHUS CAUDATUS SEED	INACTIVE INGREDIENT	FJ722PPQ9M	SMOOTHING MINERAL PRIMER SPF-15 (TITANIUM DIOXIDE) LOTION [HATCHBEAUTY PRODUCTS LLC]	2
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	SMOOTHING MINERAL PRIMER SPF-15 (TITANIUM DIOXIDE) LOTION [HATCHBEAUTY PRODUCTS LLC]	2
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	SMOOTHING MINERAL PRIMER SPF-15 (TITANIUM DIOXIDE) LOTION [HATCHBEAUTY PRODUCTS LLC]	2
GLYCERYL MONOBEHENATE	INACTIVE INGREDIENT	A626UU0W2A	SMOOTHING MINERAL PRIMER SPF-15 (TITANIUM DIOXIDE) LOTION [HATCHBEAUTY PRODUCTS LLC]	2
ISODODECANE	INACTIVE INGREDIENT	A8289P68Y2	SMOOTHING MINERAL PRIMER SPF-15 (TITANIUM DIOXIDE) LOTION [HATCHBEAUTY PRODUCTS LLC]	2
JASMINUM OFFICINALE FLOWER	INACTIVE INGREDIENT	0Q8K841432	SMOOTHING MINERAL PRIMER SPF-15 (TITANIUM DIOXIDE) LOTION [HATCHBEAUTY PRODUCTS LLC]	2
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE	INACTIVE INGREDIENT	25G622K2RA	SMOOTHING MINERAL PRIMER SPF-15 (TITANIUM DIOXIDE) LOTION [HATCHBEAUTY PRODUCTS LLC]	2
METHICONE (20 CST)	INACTIVE INGREDIENT	6777U11MKT	SMOOTHING MINERAL PRIMER SPF-15 (TITANIUM DIOXIDE) LOTION [HATCHBEAUTY PRODUCTS LLC]	2
OENOTHERA BIENNIS ROOT	INACTIVE INGREDIENT	SL194W0S0F	SMOOTHING MINERAL PRIMER SPF-15 (TITANIUM DIOXIDE) LOTION [HATCHBEAUTY PRODUCTS LLC]	2
PEACH	INACTIVE INGREDIENT	3OKE88I3QG	SMOOTHING MINERAL PRIMER SPF-15 (TITANIUM DIOXIDE) LOTION [HATCHBEAUTY PRODUCTS LLC]	2
PEG-10 DIMETHICONE (600 CST)	INACTIVE INGREDIENT	8PR7V1SVM0	SMOOTHING MINERAL PRIMER SPF-15 (TITANIUM DIOXIDE) LOTION [HATCHBEAUTY PRODUCTS LLC]	2
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	SMOOTHING MINERAL PRIMER SPF-15 (TITANIUM DIOXIDE) LOTION [HATCHBEAUTY PRODUCTS LLC]	2
POLYSILICONE-15	INACTIVE INGREDIENT	F8DRP5BB29	SMOOTHING MINERAL PRIMER SPF-15 (TITANIUM DIOXIDE) LOTION [HATCHBEAUTY PRODUCTS LLC]	2
VITIS VINIFERA SEED	INACTIVE INGREDIENT	C34U15ICXA	SMOOTHING MINERAL PRIMER SPF-15 (TITANIUM DIOXIDE) LOTION [HATCHBEAUTY PRODUCTS LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	SMOOTHING MINERAL PRIMER SPF-15 (TITANIUM DIOXIDE) LOTION [HATCHBEAUTY PRODUCTS LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69863-101	SMOOTHING MINERAL PRIMER SPF-15 (TITANIUM DIOXIDE) LOTION [HATCHBEAUTY PRODUCTS LLC]	4	Legacy NDC, 4 package rows	20151217_ec3bea36-644d-4263-970c-5e001a257fc7.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
69863-101-11	69863010111	30 mL in 1 BOTTLE, PUMP	30 ml	Historical
69863-101-12	69863010112	5 mL in 1 TUBE	5 ml	Historical
69863-101-13	69863010113	7 mL in 1 TUBE	7 ml	Historical
69863-101-51	69863010151	1 in 1 BOX		Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SMOOTHING MINERAL PRIMER SPF-15 - HATCHBEAUTY PRODUCTS LLC	HATCHBEAUTY PRODUCTS LLC	2015-12-16	HUMAN OTC DRUG LABEL	4