Sunscreen

Product NDC: 61010-6103
11-digit product format: 610106103
Labeler code: 61010
Product ID: 61010-6103_10dfe53b-4cdd-c203-e063-6294a90af360
Type: HUMAN OTC DRUG
Nonproprietary name: Homosalate, Octinoxate, Octisalate, Oxybenzone
Dosage form: LOTION
Route: TOPICAL
Labeler: Safetec of America, Inc.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2007-03-13
Substance: HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength: 6; 7.5; 5; 5 mg/g; mg/g; mg/g; mg/g
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: Sunscreen
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HOMOSALATE	6 mg/g
OCTINOXATE	7.5 mg/g
OCTISALATE	5 mg/g
OXYBENZONE	5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V06SV4M95S	Internal UNII lookup
4Y5P7MUD51	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
95OOS7VE0Y	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
754186c8-3c88-40a0-a4e3-35e3ea9d1b4c	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61010-6103-0	Sunscreen	3.5 g in 1 PACKET	LOTION	3.5	6
61010-6103-1	Sunscreen	25 in 1 BOX	LOTION	25	6
61010-6103-2	Sunscreen	2 g in 1 PACKET	LOTION	2	6
61010-6103-3	Sunscreen	25 in 1 BOX	LOTION	25	6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Homosalate	ACTIVE INGREDIENT	V06SV4M95S	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
Octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
Octisalate	ACTIVE INGREDIENT	4X49Y0596W	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
Oxybenzone	ACTIVE INGREDIENT	95OOS7VE0Y	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
Homosalate	ACTIVE MOIETY	V06SV4M95S	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
Octinoxate	ACTIVE MOIETY	4Y5P7MUD51	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
Octisalate	ACTIVE MOIETY	4X49Y0596W	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
Oxybenzone	ACTIVE MOIETY	95OOS7VE0Y	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
diazolidinyl urea	INACTIVE INGREDIENT	H5RIZ3MPW4	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
edetate sodium	INACTIVE INGREDIENT	MP1J8420LU	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
polyethylene glycol 400	INACTIVE INGREDIENT	B697894SGQ	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
polyoxyl 40 stearate	INACTIVE INGREDIENT	13A4J4NH9I	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
povidone K30	INACTIVE INGREDIENT	U725QWY32X	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
sorbitan monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
water	INACTIVE INGREDIENT	059QF0KO0R	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61010-6103	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	6	Current NDC, Legacy NDC, 4 package rows	20240214_754186c8-3c88-40a0-a4e3-35e3ea9d1b4c.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 114 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Matte Defense Mineral Sunscreen non tinted	TITANIUM DIOXIDE, ZINC OXIDE	PURE VITALITY SKIN AND BODY, INC	3698090a-1639-00f9-e063-6394a90a7dd1	2025-12-16		Exact identifier application number: M020
Daily Replenish mineral sunscreen	ZINC OXIDE	PURE VITALITY SKIN AND BODY, INC	3698d309-b9bf-e197-e063-6294a90af5a1	2025-12-16		Exact identifier application number: M020
Zinc 20 mineral sunscreen face Plus body	ZINC OXIDE	PURE VITALITY SKIN AND BODY, INC	3698f29e-5d80-94af-e063-6394a90a0489	2025-12-16		Exact identifier application number: M020
Tinted Mineral Primer SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	JOSEPHINA RAMIREZ	365cf2be-8862-3622-e063-6394a90ac4e3	2025-12-16		Exact identifier application number: M020
SANCTUARY Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	CHAMPAGNE APOTHECARY LLC	365ca99c-c878-1f4b-e063-6394a90a1f53	2025-12-16		Exact identifier application number: M020
Tinted Mineral Defense SPF 40	ZINC OXIDE	JOSEPHINA RAMIREZ	365d299a-5886-5597-e063-6394a90a336c	2025-12-16		Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	MILL VALLEY DERMATOLOGY, INC.	3b171a89-c757-47a1-e063-6294a90a7a64	2025-12-16	Warnings	Exact identifier application number: M020
Tinted BB Cream	ZINC OXIDE	Eco Esthetics LLC	38f3e618-59e1-4504-e063-6394a90afa55	2025-12-16		Exact identifier application number: M020
Tinted Mineral Sunscreen	ZINC OXIDE	MADRE TIERRA, INC.	3f697463-d3db-7b73-e063-6394a90ac222	2025-12-16	Warnings	Exact identifier application number: M020
Non-Tinted Replenishing Daily Protection	ZINC OXIDE	MADRE TIERRA, INC.	3f69d6f3-454b-e60a-e063-6394a90a8781	2025-12-16	Warnings	Exact identifier application number: M020
Mineral Sunscreen	ZINC OXIDE	ISIS GONZALEZ	3f68b2ea-be23-100d-e063-6294a90a8b37	2025-12-16	Warnings	Exact identifier application number: M020
Mineral Sunscreen	ZINC OXIDE	ISIS GONZALEZ	3f682b78-e1c9-e174-e063-6294a90a17ed	2025-12-16	Warnings	Exact identifier application number: M020
Silk Screen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Skin Science Institute Inc	36c3793a-ccb5-1e5f-e063-6294a90ad44f	2025-12-16		Exact identifier application number: M020
Silk Screen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Skin Science Institute Inc	36c3a721-6be1-3f7f-e063-6394a90a522f	2025-12-16		Exact identifier application number: M020
True Tone Tinted	TITANIUM DIOXIDE, ZINC OXIDE	That Face PLLC	36c2bb0e-479d-89cd-e063-6294a90aa3d4	2025-12-16		Exact identifier application number: M020
True Tone Non Tinted	ZINC OXIDE	That Face PLLC	36c2f263-67cf-e8cf-e063-6394a90ad81f	2025-12-16		Exact identifier application number: M020
Tinted Daily Protection Sunscreen	ZINC OXIDE	Kemmi Lee Skin Science	37ef5a05-54d2-a8e4-e063-6394a90a8e48	2025-12-16		Exact identifier application number: M020
Aquaphor Lip Repair Stick and Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE,	Beiersdorf Inc	d469bddf-90d4-7b1c-e053-2a95a90a1ed9	2025-12-16	Warnings	Exact identifier application number: M020
Eucerin Daily Protection Face	ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	Beiersdorf Inc	76403f03-aee9-4c0b-b331-f79b6953118c	2025-12-16	Warnings	Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION	36c0400b-8ad9-654b-e063-6294a90ad040	2025-12-16		Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61010-6103-0	61010610300	3.5 g in 1 PACKET	3.5 g					Historical
61010-6103-1	61010610301	25 PACKET in 1 BOX (61010-6103-1) / 3.5 g in 1 PACKET (61010-6103-0)	25 packet	2007-03-13	0000-00-00	No	No	Current
61010-6103-2	61010610302	2 g in 1 PACKET	2 g					Historical
61010-6103-3	61010610303	25 PACKET in 1 BOX (61010-6103-3) / 2 g in 1 PACKET (61010-6103-2)	25 packet	2018-07-01	0000-00-00	No	No	Current