SHADE and ILLUMINATE SOFT RAD PRMR SPF

Product NDC: 76398-013
11-digit product format: 763980013
Labeler code: 76398
Product ID: 76398-013_0b782b71-11a2-56d4-e063-6394a90a7676
Type: HUMAN OTC DRUG
Nonproprietary name: OCTINOXATE,OCTISALATE,ZINC OXIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: TOM FORD BEAUTY DIST
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-10-14
Substance: ZINC OXIDE; OCTINOXATE; OCTISALATE
Active strength: 100; 67; 45 mg/mL; mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	76398-013	76398-013-02	D	Discontinued by firm		2026-11-13

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 · 12 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…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: SHADE and ILLUMINATE SOFT RAD PRMR SPF
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	100 mg/mL
OCTINOXATE	67 mg/mL
OCTISALATE	45 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup
4Y5P7MUD51	Internal UNII lookup
4X49Y0596W	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
eac7d416-c243-4647-e053-2a95a90abcb7	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75	Product name	2	20250814
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
76398-013-01	SHADE and ILLUMINATE SOFT RAD PRMR SPF	1 in 1 CARTON	CREAM	1	4
76398-013-01	SHADE and ILLUMINATE SOFT RAD PRMR SPF	30 mL in 1 BOTTLE	CREAM	30	4
76398-013-02	SHADE and ILLUMINATE SOFT RAD PRMR SPF	3.6 mL in 1 BOTTLE	CREAM	3.6	4
76398-013-02	SHADE and ILLUMINATE SOFT RAD PRMR SPF	1 in 1 CARTON	CREAM	1	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76398-013	SHADE AND ILLUMINATE SOFT RAD PRMR SPF (OCTINOXATE,OCTISALATE,ZINC OXIDE) CREAM [TOM FORD BEAUTY DIST]	4	Current NDC, Legacy NDC, 4 package rows	20231202_eac7d416-c243-4647-e053-2a95a90abcb7.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 246 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ulta Beauty Tinted Moisturizer Cream Spf 24 Medium	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	fbc0ff10-fb2f-e637-e053-6294a90a0c29	2024-12-26	Warnings	Exact identifier application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 Deep	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	2984c64f-eaac-ecb6-e063-6394a90aeb12	2024-12-26	Warnings	Exact identifier application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 Tan	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	2984a014-a56f-753b-e063-6294a90a13f5	2024-12-26	Warnings	Exact identifier application number: M020
Julep No Excuses Gel for Face SPF40	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	298404c4-d4be-7395-e063-6294a90a86bf	2024-12-26	Warnings	Exact identifier application number: M020
Cover FX Invisible Primer SPF30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	2983dd7c-7ca7-e952-e063-6394a90a3098	2024-12-26	Warnings	Exact identifier application number: M020
3LAB WW DAY SPF40 BROAD SPECTRUM	HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE	3LAB, INC	2a2f5f9a-4e2f-4bbb-e063-6294a90ab99e	2024-12-26	Warnings	Exact identifier application number: M020
MILANI MAKE IT LAST SUNSCREEN SETTING SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	30b224f0-43f1-4c79-839e-3a970e4be3a5	2024-12-26	Warnings	Exact identifier application number: M020
CLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREEN	HOMOSALATE, OCTISALATE, AND AVOBENZONE	CLINIQUE LABORATORIES LLC	f4fe22b3-ccf2-4d67-8d20-5b5d3b69b444	2024-12-25	Warnings	Exact identifier application number: M020
CITY BLOCK SHEER Oil FREE DAILY FACE PROTECTOR BROAD SPECTRUM SPF 25	TITANIUM DIOXIDE AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	ee7e2ded-b850-4e15-96a6-556111e52187	2024-12-25	Warnings	Exact identifier application number: M020
CLINIQUE SUPER DEFENSE CITY BLOCK DAILY ENERGY PLUS FACE PROTECTOR BROAD SPECTRUM SPF 50	OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	d1a3d76f-16dd-4533-8144-9a3175f6e15f	2024-12-25	Warnings	Exact identifier application number: M020
DOUBLE WEAR MAXIMUM COVER CAMOUFLAGE MAKEUP FOR FACE AND BODY BROAD SPECTRUM SPF 15	TITANIUM DIOXIDE	ESTEE LAUDER INC	a04a9aaa-fa0f-4dde-a7a5-c4c561cc51b1	2024-12-25	Warnings	Exact identifier application number: M020
ESTEE LAUDER MULTI-DEFENSE AQUA UV gel BROAD SPECTRUM SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	ESTEE LAUDER INC	0770e251-95d0-43de-88f1-bc0a29811e4e	2024-12-25	Warnings	Exact identifier application number: M020
MAC PREP AND PRIME FACE PROTECT BROAD SPECTRUM SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	MAKEUP ART COSMETICS	c26ef380-1309-4a41-862f-eb319d38673d	2024-12-25	Warnings	Exact identifier application number: M020
STUDIO FIX FLUID SPF 15 BROAD SPECTRUM	OCTINOXATE AND TITANIUM DIOXIDE	MAKEUP ART COSMETICS	ff48435d-245a-4037-9afb-caee83c4c415	2024-12-25	Warnings	Exact identifier application number: M020
ORIGINS GINZING ENERGY-BOOSTING TINTED MOISTURIZER BROAD SPECTRUM SPF 40	OCTINOXATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE	ORIGINS NATURAL RESOURCES INC.	0fe63edf-7a49-4b33-88f1-f480f889d194	2024-12-25	Warnings	Exact identifier application number: M020
DR. ANDREW WEIL FOR ORIGINS MEGA-BRIGHT SPF 30 SKIN TONE CORRECTING oil FREE MOISTURIZER BROAD SPECTRUM SPF 30	HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE	ORIGINS NATURAL RESOURCES INC.	8e8c495e-d439-4735-a7cc-b44081b75b27	2024-12-25	Warnings	Exact identifier application number: M020
VITAZING SPF 15 ENERGY BOOSTING MOISTURIZER WITH MANGOSTEEN BROAD SPECTRUM SPF 15	AVOBENZONE, OCTISALATE, AND OCTOCRYLENE	ORIGINS NATURAL RESOURCES INC.	0fac5204-df18-4774-bb53-115513cb7ff0	2024-12-25	Warnings	Exact identifier application number: M020
LA MER THE LUMINOUS LIFTING CUSHION FOUNDATION BROAD SPECTRUM SPF 20	TITANIUM DIOXIDE	MAX HUBER RESEARCH LAB INC	66e48ce0-9a5b-4250-b07b-1622b3814c3e	2024-12-25	Warnings	Exact identifier application number: M020
ESTEE LAUDER DOUBLE WEAR SHEER LONG-WEAR MAKEUP BROAD SPECTRUM SPF 19	OCTINOXATE AND TITANIUM DIOXIDE	ESTEE LAUDER INC	2f93580c-c8e9-4822-91bf-a749cf4deb4e	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06b14a17-cab9-1b3e-e063-6394a90afe5d	2024-12-25	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76398-013-01	76398001301	1 BOTTLE in 1 CARTON (76398-013-01) / 30 mL in 1 BOTTLE	1 bottle	2022-10-14	0000-00-00	No	No	Current
76398-013-02	76398001302	1 BOTTLE in 1 CARTON (76398-013-02) > 3.6 mL in 1 BOTTLE	1 bottle	2022-10-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SHADE AND ILLUMINATE SOFT RAD PRMR SPF	TOM FORD BEAUTY DIST \| Estee Lauder Companies Inc. \| Estee Lauder Cosmetics Ltd.	2023-12-01	HUMAN OTC DRUG LABEL	4