ILLUMINATING PROTECTIVE PRIMER

Product NDC: 76398-001
11-digit product format: 763980001
Labeler code: 76398
Product ID: 76398-001_c08ab60d-9dea-4c24-9951-3baf4a1da91b
Type: HUMAN OTC DRUG
Nonproprietary name: OCTINOXATE, HOMOSALATE
Dosage form: CREAM
Route: TOPICAL
Labeler: TOM FORD BEAUTY DIST
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2009-09-01
Marketing end: 0000-00-00
Substance: OCTINOXATE; HOMOSALATE
Active strength: 8 mL/100mL; mL/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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	76398-001		I	Inactivated by FDA		2026-10-05
excluded package	package	76398-001	76398-001-01	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 · 44 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	76398-001-01	`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	76398-001-01	`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	76398-001-01	`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	76398-001-01	`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	76398-001-01	`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	76398-001-01	`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	76398-001-01	`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	76398-001-01	`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	76398-001-01	`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	76398-001-01	`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	76398-001-01	`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	76398-001-01	`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	76398-001-01	`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	76398-001-01	`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	76398-001-01	`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	76398-001-01	`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	76398-001-01	`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	76398-001-01	`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	76398-001-01	`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	76398-001-01	`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	76398-001-01	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	76398-001-01	`110d247fa046…`	`a55b01930146…`

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
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
2dc76302-91c0-4c35-ad78-99adfb049c4b	Product name	1	20200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2b	Product name	2	20180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508
d223c173-c39b-d764-47d4-d671d3088815	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76398-001-01	2019-11-13	C162847	48780-1	97449f38-d493-f6ea-e053-dbdaa90aa703	96b3109c-0f1b-48c6-9f97-4e7c621a9060

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76398-001-01	ILLUMINATING PROTECTIVE PRIMERSPF 12	1 in 1 CARTON	CREAM	1		1
76398-001-02	ILLUMINATING PROTECTIVE PRIMERSPF 12	30 mL in 1 BOTTLE	CREAM	30		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HOMOSALATE	ACTIVE INGREDIENT	V06SV4M95S	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
HOMOSALATE	ACTIVE MOIETY	V06SV4M95S	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
AMYRIS BALSAMIFERA OIL	INACTIVE INGREDIENT	I1BJ961J2E	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
BERGAMOT OIL	INACTIVE INGREDIENT	39W1PKE3JI	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
CAESALPINIA SPINOSA RESIN	INACTIVE INGREDIENT	WL3883U2PO	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
CAFFEINE	INACTIVE INGREDIENT	3G6A5W338E	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
CANANGA OIL	INACTIVE INGREDIENT	8YOY78GNNX	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
CETETH-10 PHOSPHATE	INACTIVE INGREDIENT	4E05O5N49G	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
CHLORPHENESIN	INACTIVE INGREDIENT	I670DAL4SZ	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
COCONUT OIL	INACTIVE INGREDIENT	Q9L0O73W7L	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
DIHEXADECYL PHOSPHATE	INACTIVE INGREDIENT	2V6E5WN99N	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
DIPTERYX ODORATA SEED	INACTIVE INGREDIENT	D43A5L1U6L	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
EPILOBIUM ANGUSTIFOLIUM LEAF	INACTIVE INGREDIENT	7NV86426N2	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
EVENING PRIMROSE OIL	INACTIVE INGREDIENT	3Q9L08K71N	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
MICA	INACTIVE INGREDIENT	V8A1AW0880	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
PATCHOULI OIL	INACTIVE INGREDIENT	F3IN55X5PO	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
PEG-40 STEARATE	INACTIVE INGREDIENT	ECU18C66Q7	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
PHENYL TRIMETHICONE	INACTIVE INGREDIENT	DR0K5NOJ4R	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
PROPYLENE GLYCOL LAURATES	INACTIVE INGREDIENT	40KT317HGP	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
SAPINDUS MUKOROSSI FRUIT	INACTIVE INGREDIENT	66H9NW427Y	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
SHEA BUTTER	INACTIVE INGREDIENT	K49155WL9Y	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
SORBITAN MONOLAURATE	INACTIVE INGREDIENT	6W9PS8B71J	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
SORBITAN MONOSTEARATE	INACTIVE INGREDIENT	NVZ4I0H58X	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
SQUALANE	INACTIVE INGREDIENT	GW89575KF9	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
STANNIC OXIDE	INACTIVE INGREDIENT	KM7N50LOS6	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
VANILLA	INACTIVE INGREDIENT	Q74T35078H	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
VETIVER OIL	INACTIVE INGREDIENT	9M9P32M01L	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76398-001	ILLUMINATING PROTECTIVE PRIMER SPF 12 (OCTINOXATE, HOMOSALATE) CREAM [TOM FORD BEAUTY DIST]	1	Legacy NDC, 2 package rows	20111021_96b3109c-0f1b-48c6-9f97-4e7c621a9060.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
76398-001-01	76398000101	1 in 1 CARTON		Historical
76398-001-02	76398000102	30 mL in 1 BOTTLE	30 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ILLUMINATING PROTECTIVE PRIMER SPF 12	TOM FORD BEAUTY DIST \| ESTEE LAUDER COSMETICS, LTD \| ESTEE LAUDER N.V. \| Len-Ron Manufacturing Division of Aramis Inc. \| Aramis Inc. \| Northtec Bristol \| Northtec Keystone \| Estee Lauder Pennsylvania Distribution Center 2 \| Estee Lauder Cosmetics, Ltd. \| Estee Lauder Cosmetics Distribution Center \| Estee Lauder Kabushiki Kaisha \| Whitman Laboratories Ltd. \| Aveda Corporation	2011-10-20	HUMAN OTC DRUG LABEL	1