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 38 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RE SCREEN BROAD SPECTRUM SPF 30 SUNSCREEN	ZINC OXIDE	Zouck LLC	507560fe-c7ad-329a-e063-6394a90a039a	2026-04-27	Warnings	Exact identifier application number: M020
SoloVegan	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	YES SALES INC.	435748e6-c39a-efee-e063-6294a90ad0e5	2026-04-27	Warnings	Exact identifier application number: M020
SCREEN SCREEN BROAD SPECTRUM SPF 30 SUNSCREEN	ZINC OXIDE	Zouck LLC	50764f40-7881-81a3-e063-6294a90ad1cf	2026-04-27	Warnings	Exact identifier application number: M020
Obagi Skintrinsiq Antioxidant Protocol	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	Obagi Cosmeceuticals LLC	495bc176-b292-448f-a5a6-00de2e475e54	2026-04-27	Warnings	Exact identifier application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30	BRIGHTENING SKIN TINT	PML NYC, LLC	f45bd7bd-a802-33e4-e053-2a95a90a61a7	2026-04-23	Warnings	Exact identifier application number: M020
TRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMER	TRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMER	PML NYC, LLC	1c2e9b0d-ba0e-1767-e063-6394a90a756c	2026-04-23	Warnings	Exact identifier application number: M020
Skincare LdeL Retinol Day Broad Spectrum SPF 20	AVOBENZONE, HOMOSALATE, OXYBENZONE, AND OCTINOXATE	Beauty Solutions, Ltd.	76e2ed34-c643-402b-9c9d-04eac789d3c2	2026-04-22	Warnings	Exact identifier application number: M020
Johnsons Baby Mineral Sunscreen SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Kenvue Brands LLC	4fe04c4b-2751-0561-e063-6394a90af768	2026-04-22	Warnings	Exact identifier application number: M020
Johnsons Baby Mineral Sunscreen Stick SPF 50	ZINC OXIDE	Kenvue Brands LLC	4fe1d3c6-7748-d966-e063-6394a90a97ff	2026-04-22	Warnings	Exact identifier application number: M020
OVERLAPS ECTOIN MOIST SUN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Overlaps Corp.	4c3ed60b-e515-8ff0-e063-6294a90a86df	2026-04-22	Warnings	Exact identifier application number: M020
Lazy Face SPF 30 Facescreen	TITANIUM DIOXIDE, ZINC OXIDE	Sunny Day Creations	500ee303-7302-68d5-e063-6394a90ac6d4	2026-04-22	Warnings	Exact identifier application number: M020
Lazy Face SPF 30 Facestick	ZINC OXIDE	Sunny Day Creations	50101b55-793e-dbe4-e063-6394a90a6199	2026-04-22	Warnings	Exact identifier application number: M020
Broad Spectrum Sunscreen SPF 30	OCTOCRYLENE 10% HOMOSALATE 10% OCTISALATE 5 % AVOBENZONE 3%	S&C Hampton Sun LLC	e6103de6-1d80-46fd-b9d4-893f60941def	2026-04-22	Warnings	Exact identifier application number: M020
PhotoAge Guard	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	MACROMOTION, INC.	50164bd8-469d-9ec1-e063-6294a90a543d	2026-04-22	Warnings	Exact identifier application number: M020
THANK YOU FARMER Sun Project Silky Calming Sun Stick	AVOBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENE	THANK YOU FARMER CO., LTD	49947114-5137-dc45-e063-6394a90ad9d0	2026-04-22	Warnings	Exact identifier application number: M020
Sky and Sol Intense Healing Lip Jelly	NON-NANO ZINC OXIDE	Delta Ecommerce LLC	2ddaa215-7433-c8fa-e063-6394a90a4316	2026-04-22	Warnings	Exact identifier application number: M020
Broad Spectrum SPF45	ZINC OXIDE, OCTINOXATE	Drmtlgy, LLC	0445ee5f-45a8-4fd5-ae4d-62f66e6f0be8	2026-04-21	Warnings	Exact identifier application number: M020
BLDG Active Skin Repair Face and Body Performance Sunscreen	ZINC OXIDE	Innovacyn, Inc.	70cb98cf-739b-4d46-b45a-535ff0a4531c	2026-04-21	Warnings	Exact identifier application number: M020
Freaks of Nature Mineral Sunscreen	ZINC OXIDE MINERAL SUNSCREEN	Empack Spraytech Inc.	4ffdb1c6-b2c6-628f-e063-6394a90a2769	2026-04-21	Warnings	Exact identifier application number: M020
THANK YOU FARMER Sun Project Water Sun Cream	AVOBENZONE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENE	THANK YOU FARMER CO., LTD	5004126b-0a9c-21fb-e063-6294a90a5237	2026-04-21	Warnings	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