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 42 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EltaMD UV Restore Tinted	TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREEN	CP Skin Health Group, Inc.	6a48ad0d-20e4-44b1-90d6-30bfbc68a152	2026-04-17	Warnings	Exact identifier application number: M020
Pacto Refreshing Sunscreen Broad Spectrum SPF 50	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Mynd LLC	56ad7c97-3dae-4bac-a677-f5052dfdfea4	2026-04-16	Warnings	Exact identifier application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Medium)	TITANIUM DIOXIDE, ZINC OXIDE	ZO Skin Health Inc.	4f95cd0a-f996-648b-e063-6294a90adc28	2026-04-16	Warnings	Exact identifier application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Tan)	TITANIUM DIOXIDE, ZINC OXIDE	ZO Skin Health Inc.	4f968058-e851-86d0-e063-6294a90aa786	2026-04-16	Warnings	Exact identifier application number: M020
Red Cherry SPF 15 Broad Spectrum Lip Balm	RED CHERRY SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	4f96d057-39b8-e4d5-e063-6394a90acb5c	2026-04-16	Warnings	Exact identifier application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Deep)	TITANIUM DIOXIDE, ZINC OXIDE	ZO Skin Health Inc.	4f970778-97d6-40a9-e063-6394a90a6c89	2026-04-16	Warnings	Exact identifier application number: M020
ZO Skin Health Sheer Fluid Tint Broad-Spectrum Sunscreen SPF 45 Fair-Light	ZINC OXIDE	ZO Skin Health, Inc.	4f9988a0-ae4a-9940-e063-6294a90ad91d	2026-04-16	Warnings	Exact identifier application number: M020
MELAO Hydrating Mineral Sunscreen	TITANIUM DIOXIDE,ZINC OXIDE	Guangdong Aimu Biological Technology Co., Ltd	4f778eb0-55f7-38d0-e063-6394a90a69a0	2026-04-15	Warnings	Exact identifier application number: M020
Tanning Club Everyday Sunscreen SPF 30	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	TANNING CLUB, LLC	75820400-a5e0-4cf5-8b4f-a52500ce62c3	2026-04-15	Warnings	Exact identifier application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45	TITANIUM DIOXIDE, ZINC OXIDE	ZO Skin Health Inc.	4f81e482-8111-451c-e063-6294a90ad148	2026-04-15	Warnings	Exact identifier application number: M020
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	UNDRBUDR, LLC	4f8353b3-4ac1-9703-e063-6294a90abdad	2026-04-15	Warnings	Exact identifier application number: M020
Mineral Sunscreen Stick Non-Tinted	TITANIUM DIOXIDE, ZINC OXIDE	UNDRBUDR, LLC	4f83dd76-a8d8-916e-e063-6294a90ab6ed	2026-04-15	Warnings	Exact identifier application number: M020
Mineral Sunscreen Stick - Tinted	TITANIUM DIOXIDE, ZINC OXIDE	UNDRBUDR, LLC	4f84619f-3415-7443-e063-6394a90a162a	2026-04-15	Warnings	Exact identifier application number: M020
Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Ivory	TITANIUM DIOXIDE AND ZINC OXIDE	PML NYC, LLC	1be639a8-179a-7015-e063-6394a90ab64b	2026-04-15	Warnings	Exact identifier application number: M020
PHELITYL DAY SPF 15	PHELITYL DAY SPF 15	PML NYC, LLC	ea9d33d9-6f9f-0a66-e053-2a95a90abd42	2026-04-15	Warnings	Exact identifier application number: M020
FIRMARINE MOISTURIZER SPF 30	FIRMARINE MOISTURIZER SPF 30	PML NYC, LLC	ea9db179-1b69-01e0-e053-2a95a90a1628	2026-04-15	Warnings	Exact identifier application number: M020
EVEN TRUE NUTRITIVE SKIN MOISTURIZER SPF 15	EVEN TRUE NUTRITIVE SKIN MOISTURIZER SPF 15	PML NYC, LLC	eaa562b1-3fc6-1a85-e053-2995a90ad1ec	2026-04-15	Warnings	Exact identifier application number: M020
DD Cream Dermatologically Defining BB Cream Broad Spectrum SPF 30	DD CREAM DERMATOLOGICALLY DEFINING BB CREAM BROAD SPECTRUM SPF 30	PML NYC, LLC	ea90bb4d-6f4a-45c9-e053-2a95a90a53a7	2026-04-15	Warnings	Exact identifier application number: M020
RICH GIRL HAND SPF 25	RICH GIRL HAND	PML NYC, LLC	ea8f4421-109f-41a5-e053-2a95a90a3832	2026-04-15	Warnings	Exact identifier application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- ALABASTER	YOUR NAME MINERAL SHEER TINT	PML NYC, LLC	0e24a63e-d76f-6581-e063-6394a90a6181	2026-04-15	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