Foundation Primer Plus SPF 15

Product NDC: 57627-108
11-digit product format: 576270108
Labeler code: 57627
Product ID: 57627-108_5da9729b-24d0-c556-e063-6394a90abc98
Type: HUMAN OTC DRUG
Nonproprietary name: octinoxate, octisalate
Dosage form: CREAM
Route: TOPICAL
Labeler: Merle Norman Cosmetics, Inc
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-04-22
Substance: OCTINOXATE; OCTISALATE
Active strength: 2.63; 1.75 g/35g; g/35g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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: Foundation Primer Plus SPF 15
Brand name suffix: MERLE NORMAN
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTINOXATE	2.63 g/35g
OCTISALATE	1.75 g/35g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
57627-108-01	Foundation Primer Plus SPF 15MERLE NORMAN	35 g in 1 TUBE	CREAM	35	17
57627-108-02	Foundation Primer Plus SPF 15MERLE NORMAN	1 in 1 BOX	CREAM	1	17
57627-108-03	Foundation Primer Plus SPF 15MERLE NORMAN	5 g in 1 TUBE	CREAM	5	17
57627-108-04	Foundation Primer Plus SPF 15MERLE NORMAN	1 in 1 BOX	CREAM	1	17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]	10
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]	10
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]	10
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]	10
ALKYL (C12-15) BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]	10
ASCORBYL PALMITATE	INACTIVE INGREDIENT	QN83US2B0N	FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]	10
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]	10
CAMELLIA OLEIFERA LEAF	INACTIVE INGREDIENT	5077EL0C60	FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]	10
CERAMIDE 2	INACTIVE INGREDIENT	C04977SRJ5	FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]	10
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]	10
CYCLOMETHICONE 6	INACTIVE INGREDIENT	XHK3U310BA	FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]	10
PALMITOYL TRIPEPTIDE-1	INACTIVE INGREDIENT	HO4ZT5S86C	FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]	10
PEG-10 RAPESEED STEROL	INACTIVE INGREDIENT	258O76T85M	FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]	10
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]	10
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]	10
TRIBEHENIN	INACTIVE INGREDIENT	8OC9U7TQZ0	FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]	10
TRISILOXANE	INACTIVE INGREDIENT	9G1ZW13R0G	FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]	10
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57627-108	FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]	16	Current NDC, Legacy NDC, 4 package rows	20241004_582ce0b2-addc-4b87-9334-c8f515b10a16.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 3 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sunski Hot Block Mineral Sunscreen Stick SPF 50	ZINC OXIDE	Stewart Charley Ventures LLC dba Sunski	04ecc5e7-0d9e-4bc7-b964-4cbcc6ed06a8	2026-09-01	Warnings	Exact identifier application number: M020
Sun Wave Anti Aging Insta Dry SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	7e48a3d2-e453-4733-b42b-8bea804cda59	2026-09-01	Warnings	Exact identifier application number: M020
Sun Wave Anti Aging Lite SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	7204c24f-aab6-45eb-9bd4-879f715ba075	2026-09-01	Warnings	Exact identifier application number: M020
Sun Wave Anti Aging Lite SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	7c1e780a-1831-4f49-a92e-e36017d241a2	2026-09-01	Warnings	Exact identifier application number: M020
Sun Wave Cross Sport Insta Dry SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	d45614c8-b09c-417b-b691-082ea2149880	2026-09-01	Warnings	Exact identifier application number: M020
Sun Wave Cross Sport Insta Dry SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	999b0b17-be73-4d42-b182-ce038f493301	2026-09-01	Warnings	Exact identifier application number: M020
Sun Wave Cross Sport Insta Dry SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	adffff46-4cfb-4c0a-b1a6-75220ee193a5	2026-09-01	Warnings	Exact identifier application number: M020
Sun Wave Cross Sport Insta Dry SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	13b2b45b-70e1-46ff-8555-48e1fe98c651	2026-09-01	Warnings	Exact identifier application number: M020
Sun Wave Kids Insta Dry SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	5c2a5ca3-e9eb-48ba-8698-592d2c7aa241	2026-09-01	Warnings	Exact identifier application number: M020
Sunceutical SPF 50 Mineral Face Cream	ZINC OXIDE	Baxter Laboratories Pty. Ltd.	2c408728-a1de-d51e-e063-6294a90ade0b	2026-08-31	Warnings	Exact identifier application number: M020
SKIN1004 MADAGASCAR CENTELLA HYALU-CICA WATER-FIT SUN SERUM UV	BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENE	Craver Corporation	38d8c1c9-86b5-1edd-e063-6394a90aeb47	2026-08-30	Warnings	Exact identifier application number: M020
ISNTREE HYALURONIC ACID DAILY SUNGEL	AVOBENZONE, HOMOSALATE, OCTISALATE	ISNTREE Inc.	5a3a17ff-a7fd-f707-e063-6394a90a3182	2026-08-29	Warnings	Exact identifier application number: M020
ISNTREE HYALURONIC ACID NATURAL SUNCREAM	ZINC OXIDE	ISNTREE Inc.	5a3a59b2-18b6-521b-e063-6294a90a2958	2026-08-29	Warnings	Exact identifier application number: M020
Cetaphil Daily Facial Moisturizer with suncreen SPF 35	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Galderma Laboratories, L.P.	f5eb347f-0d46-4de6-8f3f-9010327678ed	2026-08-28	Warnings	Exact identifier application number: M020
Utu Broad Spectrum SPF 30 Moisturizing Body Sunscreen	ZINC OXIDE	Utu Co	59938ace-c97c-d758-e063-6394a90a77e4	2026-08-28	Warnings	Exact identifier application number: M020
Utu Broad Spectrum SPF 30 Moisturizing Face Mineral Zinc Oxide Sunscreen Unscented	ZINC OXIDE	Utu Co	5982e790-7cdb-c96c-e063-6394a90a02d4	2026-08-28	Warnings	Exact identifier application number: M020
Utu Hydrating Sun Balm Broad Spectrum SPF 50	ZINC OXIDE	Utu Co	59d1d0ac-2444-d6f9-e063-6294a90ae80c	2026-08-28	Warnings	Exact identifier application number: M020
Hello Bello Mineral Sunscreen SPF 50	ZINC OXIDE	Topiderm, Inc.	54f12764-5c37-4a05-bf96-209fedb93fd1	2026-08-28	Warnings	Exact identifier application number: M020
ISNTREE HYALURONIC ACID DAILY SUNGEL	AVOBENZONE, HOMOSALATE, OCTISALATE	ISNTREE Inc.	5a02c540-5b3b-9379-e063-6294a90a00f6	2026-08-27	Warnings	Exact identifier application number: M020
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50	SUNSCREEN SPF50	Guangzhou Meixi Biotechnology Co., Ltd.	5a0b4bd2-f6ad-35dc-e063-6294a90a8a66	2026-08-27	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
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
57627-108-01	57627010801	35 g in 1 TUBE	35 g					Historical
57627-108-02	57627010802	1 TUBE in 1 BOX (57627-108-02) / 35 g in 1 TUBE (57627-108-01)	1 tube	2011-04-22	0000-00-00	No	No	Current
57627-108-03	57627010803	5 g in 1 TUBE	5 g					Historical
57627-108-04	57627010804	1 TUBE in 1 BOX (57627-108-04) / 5 g in 1 TUBE (57627-108-03)	1 tube	2011-04-22	0000-00-00	No	No	Current