SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30

Product NDC: 49527-083
11-digit product format: 495270083
Labeler code: 49527
Product ID: 49527-083_0a35474f-c644-433e-e063-6294a90a3a75
Type: HUMAN OTC DRUG
Nonproprietary name: AVOBENZONE,HOMOSALATE,OCTINOXATE,OCTISALATE
Dosage form: CREAM
Route: TOPICAL
Labeler: CLINIQUE LABORATORIES LLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-05-12
Substance: AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE
Active strength: 30; 70; 35; 45 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	49527-083-00	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	49527-083-00	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	49527-083-00	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	49527-083-00	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	49527-083-00	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	49527-083-00	`50b4072663b7…`	`eae3003ed65e…`

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: SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AVOBENZONE	30 mg/mL
HOMOSALATE	70 mg/mL
OCTINOXATE	35 mg/mL
OCTISALATE	45 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G63QQF2NOX	Internal UNII lookup
V06SV4M95S	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
fb841fd7-0c78-01a1-e053-6394a90a4382	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49527-083-01	SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30	1 in 1 CARTON	CREAM	1	2
49527-083-01	SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30	50 mL in 1 JAR	CREAM	50	2
49527-083-02	SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30	75 mL in 1 JAR	CREAM	75	2
49527-083-02	SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30	1 in 1 CARTON	CREAM	1	2
49527-083-03	SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30	1 in 1 CARTON	CREAM	1	2
49527-083-03	SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30	15 mL in 1 JAR	CREAM	15	2
49527-083-04	SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30	1 in 1 CARTON	CREAM	1	2
49527-083-04	SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30	5 mL in 1 JAR	CREAM	5	2
49527-083-05	SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30	30 mL in 1 JAR	CREAM	30	2
49527-083-05	SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30	1 in 1 CARTON	CREAM	1	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49527-083	SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30 (AVOBENZONE,HOMOSALATE,OCTINOXATE,OCTISALATE) CREAM [CLINIQUE LABORATORIES LLC]	2	Current NDC, 10 package rows	20231116_fb841fd7-0c78-01a1-e053-6394a90a4382.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 107 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HAWAIIAN TROPIC SUNSCREEN CLEAR WEIGHTLESS HYDRATION SPF70	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	e686a22f-bddc-5d7c-e053-2995a90a7b28	2025-12-18	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	090904d1-c04c-3fca-e063-6294a90a7cc7	2025-12-18	Warnings	Exact identifier application number: M020
Bye Bye Foundation Full Coverage Moisturizer SPF 50 Fair	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	b098aba3-dad6-4421-a943-e88ce5e2f8d6	2025-12-18	Warnings	Exact identifier application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Fair Ivory Fair Warm Fair Beige Medium Tan Warm Tan Rich Neutral Rich Neutral Deep Deep Bronze Deep Honey Deep Mocha	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	b3260833-8b7c-4d88-a55a-8cef4938442d	2025-12-18	Warnings	Exact identifier application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Medium Medium Tan Neutral Rich	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	0a647c9a-2c71-4cd2-9503-e9ab96b857ee	2025-12-18	Warnings	Exact identifier application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Fair Light LightMedium Medium Tan TanRich RichDeep	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	f246553e-17c2-4dba-855b-1942646bb834	2025-12-18	Warnings	Exact identifier application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Medium Tan Warm Neutral Rich Deep Bronze Neutral Deep Deep Bronze	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	15de58a4-e2bc-425b-b50b-df2d87dd3bb4	2025-12-18	Warnings	Exact identifier application number: M020
it cosmetics Your Skin But Better CC Plus Illumination Color Correcting Illuminating Broad Spectrum SPF 50 Plus Sunscreen Full Coverage FairLight NeutralTan RichHoney LightMedium and NeutralMedium	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	f493c3ea-41b3-4625-84a6-fab545a76940	2025-12-18	Warnings	Exact identifier application number: M020
YOUR SKIN BUT BETTER FAIR	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	472f34c5-cefe-4884-9475-fd0666c925ac	2025-12-18	Warnings	Exact identifier application number: M020
First Aid Beauty FAB Broad Spectrum Sunscreen SPF 30	OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE	The Procter & Gamble Manufacturing Company	d7238996-374b-07aa-e053-2995a90ae889	2025-12-18	Warnings	Exact identifier application number: M020
Olay Regenerist Hyaluronic plus Peptide 24 Hydrating Moisturizer with Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	eadacdae-3901-3f7c-e053-2a95a90ab184	2025-12-18	Warnings	Exact identifier application number: M020
First Aid Beauty FAB Ultra Repair Face Moisturizer with Sunscreen Broad Spectrum SPF 30	OCTOCRYLENE, AND ZINC OXIDE	The Procter & Gamble Manufacturing Company	f6801575-6081-7566-e053-2995a90a20a8	2025-12-18	Warnings	Exact identifier application number: M020
Olay Regenerist Regenerating with Sunscreen Broad Spectrum SPF 15	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	00280745-908b-468f-e063-6294a90aa12f	2025-12-18	Warnings	Exact identifier application number: M020
OLAY Prime plus Protect Facial Sunscreen with Vitamin C SPF35 Matte Finish	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	10bd41ac-9b96-840d-e063-6394a90a98d9	2025-12-18	Warnings	Exact identifier application number: M020
Olay Glow plus Protect Sunscreen Dewy Glow SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	The Procter & Gamble Manufacturing Company	10bc4127-7569-d0de-e063-6294a90a97bf	2025-12-18	Warnings	Exact identifier application number: M020
First Aid Beauty FAB Hydrating Sunscreen Milk Broad Spectrum SPF 45	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	29645d90-a444-4090-e063-6294a90ac7e3	2025-12-18	Warnings	Exact identifier application number: M020
Skin On Skin BC Foundation SPF 40 - Tan Golden	OCTISALATE, HOMOSALATE, ZINC OXIDE	YENSA Beauty, LLC	46440bac-de69-e59c-e063-6394a90a76c0	2025-12-18	Warnings	Exact identifier application number: M020
FUSIDYNE DERMA TROUBLE Zinc Calming Sunscreen	ZINC OXIDE	DONG WHA PHARM. CO., LTD.	46457c78-74d6-ea6a-e063-6294a90a24ac	2025-12-18	Warnings	Exact identifier application number: M020
THE MUG GUARD Invisible Gel Suncare for Face	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Dune Suncare, Inc.	4646988c-1060-ed5f-e063-6394a90aa765	2025-12-18	Warnings	Exact identifier application number: M020
Sage and Zinc Facial Hydrating SPF15	ZINC OXIDE	Emeis Cosmetics Pty Ltd	ccabd647-ecdd-7230-e053-2a95a90a7a96	2025-12-18	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
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	Sample	Exclude flag	Status
49527-083-01	49527008301	1 JAR in 1 CARTON (49527-083-01) / 50 mL in 1 JAR	1 jar	2023-05-12	No	No	Current
49527-083-02	49527008302	1 JAR in 1 CARTON (49527-083-02) / 75 mL in 1 JAR	1 jar	2023-05-12	No	No	Current
49527-083-03	49527008303	1 JAR in 1 CARTON (49527-083-03) / 15 mL in 1 JAR	1 jar	2023-05-12	No	No	Current
49527-083-04	49527008304	1 JAR in 1 CARTON (49527-083-04) / 5 mL in 1 JAR	1 jar	2023-05-12	No	No	Current
49527-083-05	49527008305	1 JAR in 1 CARTON (49527-083-05) / 30 mL in 1 JAR	1 jar	2023-05-12	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CLINIQUE SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30	CLINIQUE LABORATORIES LLC \| Estee Lauder Companies Inc. \| Estee Lauder Cosmetics Ltd \| Estee Lauder Cosmetics Ltd.	2023-11-15	HUMAN OTC DRUG LABEL	2