Home NDC 61010-6103 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.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength 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 Uploaded 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 26 of 357 · 7,139 matching rows.
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