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 116 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	ESTHETIC ACADEMY LLC	36c0c1ca-80a8-9d37-e063-6294a90a824f	2025-12-16		Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	ESTHETIC ACADEMY LLC	36c0f5df-6bfb-3c0d-e063-6294a90a2e5f	2025-12-16		Exact identifier application number: M020
Daily Protect Mineral Sunscreen	ZINC OXIDE	SARAH'S	4617beb7-381e-8994-e063-6394a90a14b5	2025-12-16	Warnings	Exact identifier application number: M020
SHISEIDO URBAN ENVIRONMENT	ENSULIZOLE, HOMOSALATE, OCTISALATE, ZINC OXIDE	Shiseido Americas Corporation	8db9f5e0-a8d6-4872-b4c6-cb92c43d25c2	2025-12-16	Warnings	Exact identifier application number: M020
cle de peau BEAUTE UV PROTECTIVE N	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Shiseido Americas Corporation	18ed9b7f-bdbe-45d7-a38c-6d065080ae99	2025-12-16	Warnings	Exact identifier application number: M020
cle de peau BEAUTE UV PROTECTIVE FOR BODY N	ENSULIZOLE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	Shiseido Americas Corporation	a2bbf6f8-b8ad-4cd9-abeb-7ec0a4ddb45c	2025-12-16	Warnings	Exact identifier application number: M020
b.tan Beach Please SPF 7	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Marque of Brands Americas, LLC	bdc07d83-a34f-5262-e053-2995a90acfc3	2025-12-16	Warnings	Exact identifier application number: M020
Daily Protect Tinted Mineral Sunscreen	ZINC OXIDE	SARAH'S	461910bd-1f74-f99e-e063-6394a90ae30e	2025-12-16	Warnings	Exact identifier application number: M020
Daily Protect Tinted Mineral Sunscreen	ZINC OXIDE	SARAH'S	4619b08f-3e63-25aa-e063-6294a90a78d7	2025-12-16	Warnings	Exact identifier application number: M020
meg	ALL DAY SOOTHE SUN SHIELD BROAD SPECTRUM SPF48	Meg Cosmetics Inc	4526bacf-6451-b297-e063-6294a90af71a	2025-12-16	Warnings	Exact identifier application number: M020
Total Eye 3-In-1 Renewal Therapy SPF 35	TITANIUM DIOXIDE AND ZINC OXIDE	Colorescience	4b116cc4-94d2-4bfc-b7f9-5f486a194c6c	2025-12-16	Warnings	Exact identifier application number: M020
Daily SPF Facial SunscreenLotion Broad Spectrum SPF 32	ZINC OXIDE	Onekind.25	c11197f4-cee0-04b3-e053-2995a90a1ba8	2025-12-15	Warnings	Exact identifier application number: M020
Crunchi Sunlight Tinted Sunscreen SPF 30 Medium Deep	ZINC OXIDE	Crunchi, LLC.	69618265-2ebb-4cdc-a28f-e36c07fe5b8f	2025-12-15	Warnings	Exact identifier application number: M020
Crunchi Sunlight Tinted Sunscreen SPF 30 Medium	ZINC OXIDE	Crunchi, LLC.	23248bc3-1b82-443a-b38a-df7f0efb5d2a	2025-12-15	Warnings	Exact identifier application number: M020
Crunchi Sunlight Tinted Sunscreen SPF 30 Light	ZINC OXIDE	Crunchi, LLC.	cf4039f5-00ee-4227-a3dc-61995c800135	2025-12-15	Warnings	Exact identifier application number: M020
Crunchi Sunlight Body Sunscreen SPF 30	ZINC OXIDE	Crunchi, LLC.	227f5a41-8c3c-492d-947f-e2b046208bca	2025-12-15	Warnings	Exact identifier application number: M020
Crunchi Sunlight Tinted Sunscreen SPF 30 Light Medium	ZINC OXIDE	Crunchi, LLC.	5b3f2766-065b-4817-a5ff-bd1c7882bfc9	2025-12-15	Warnings	Exact identifier application number: M020
Crunchi Sunlight Daily Facial Sunscreen SPF 30	ZINC OXIDE	Cruchi, LLC.	4f3bcfa0-e43e-4284-afaa-6488ddd749f0	2025-12-15	Warnings	Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	The Essential Brazilian Spa LLC	3543a22c-34d5-e572-e063-6394a90ad579	2025-12-15		Exact identifier application number: M020
Stellar Tinted Mineral Sunscreen Stick	TITANIUM DIOXIDE, ZINC OXIDE	The Essential Brazilian Spa LLC	3bb6488c-d216-8742-e063-6394a90a16e2	2025-12-15	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