SPF 50

Product NDC: 49527-717
11-digit product format: 495270717
Labeler code: 49527
Product ID: 49527-717_ed67f891-45eb-4ce2-a39e-91d71ec741a8
Type: HUMAN OTC DRUG
Nonproprietary name: oxybenzone, octisalate, homosalate, avobenzone, and octocrylene
Dosage form: CREAM
Route: TOPICAL
Labeler: CLINIQUE LABORATORIES INC.
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2009-01-01
Marketing end: 0000-00-00
Substance: OXYBENZONE; OCTISALATE; HOMOSALATE; AVOBENZONE; OCTOCRYLENE
Active strength: 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL
NDC exclude flag: E
Listing certified through: 2018-12-31
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	49527-717		I	Inactivated by FDA		2026-10-05
excluded package	package	49527-717	49527-717-01	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	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49527-717-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49527-717-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49527-717-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49527-717-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49527-717-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49527-717-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49527-717-01	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49527-717-01	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49527-717-01	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49527-717-01	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49527-717-01	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49527-717-01	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	49527-717-01	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	49527-717-01	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	49527-717-01	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	49527-717-01	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	49527-717-01	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	49527-717-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	49527-717-01	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	49527-717-01	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	49527-717-01	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	49527-717-01	E	Excluded after deficient or non-compliant submission was not corrected	`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
49527-717-01	2020-01-31	C162847	48780-1	9d75b9d0-05c5-f424-e053-dadaa90a57ce	CLINIQUE SPF 50 face cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49527-717-01	SPF 50 with SOLAR SMART	50 mL in 1 BOTTLE	CREAM	50		1
49527-717-01	SPF 50 with SOLAR SMART	1 in 1 CARTON	CREAM	1		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
avobenzone	ACTIVE INGREDIENT	G63QQF2NOX	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
homosalate	ACTIVE INGREDIENT	V06SV4M95S	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
octisalate	ACTIVE INGREDIENT	4X49Y0596W	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
octocrylene	ACTIVE INGREDIENT	5A68WGF6WM	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
oxybenzone	ACTIVE INGREDIENT	95OOS7VE0Y	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
avobenzone	ACTIVE MOIETY	G63QQF2NOX	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
homosalate	ACTIVE MOIETY	V06SV4M95S	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
octisalate	ACTIVE MOIETY	4X49Y0596W	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
octocrylene	ACTIVE MOIETY	5A68WGF6WM	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
oxybenzone	ACTIVE MOIETY	95OOS7VE0Y	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
alpha-tocopherol acetate	INACTIVE INGREDIENT	9E8X80D2L0	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
butylene glycol	INACTIVE INGREDIENT	3XUS85K0RA	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
butyloctyl salicylate	INACTIVE INGREDIENT	2EH13UN8D3	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
caffeine	INACTIVE INGREDIENT	3G6A5W338E	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
caprylyl glycol	INACTIVE INGREDIENT	00YIU5438U	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
ethylhexylglycerin	INACTIVE INGREDIENT	147D247K3P	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
hexylene glycol	INACTIVE INGREDIENT	KEH0A3F75J	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
masoprocol	INACTIVE INGREDIENT	7BO8G1BYQU	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
methyl trimethicone	INACTIVE INGREDIENT	S73ZQI0GXM	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
mica	INACTIVE INGREDIENT	V8A1AW0880	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
neopentyl glycol diheptanoate	INACTIVE INGREDIENT	5LKW3C543X	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
peg-100 stearate	INACTIVE INGREDIENT	YD01N1999R	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
peg-8 laurate	INACTIVE INGREDIENT	762O8IWA10	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
perilla frutescens leaf	INACTIVE INGREDIENT	T4L5881Y68	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
potassium cetyl phosphate	INACTIVE INGREDIENT	03KCY6P7UT	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
propyl gallate	INACTIVE INGREDIENT	8D4SNN7V92	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
rosemary	INACTIVE INGREDIENT	IJ67X351P9	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
shea butter	INACTIVE INGREDIENT	K49155WL9Y	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
sodium dehydroacetate	INACTIVE INGREDIENT	8W46YN971G	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
sucrose	INACTIVE INGREDIENT	C151H8M554	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1
xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49527-717	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1	Legacy NDC, 2 package rows	20111021_e0f986c0-2be3-47ae-aef8-a8a3f14e9cee.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
49527-717-01	49527071701	50 mL in 1 BOTTLE	50 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CLINIQUE SPF 50 face cream	CLINIQUE LABORATORIES INC. \| ELGC Kabushiki Kaisha \| Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) \| ARAMIS, INC \| ESTEE LAUDER COSMETICS DISTRIBUTION CENTER \| ESTEE LAUDER COSMETICS, LTD \| ESTEE LAUDER COSMETICS, LTD. \| ESTEE LAUDER N.V. \| LEN-RON MANUFACTURING DIVISION OF ARAMIS INC \| NORTEC KEYSTONE \| NORTHTEC BRISTOL \| NORTHTEC KEYSTONE \| WHITMAN LABORATORIES, LTD. \| Aveda Corporation	2011-10-12	HUMAN OTC DRUG LABEL	1