FDA.reportPublic FDA data

NDC 61010-6103-2 - Sunscreen

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
61010-6103
Requested NDC
61010-6103-2
Package NDCs from labels
61010-6103-0, 61010-6103-1, 61010-6103-2, 61010-6103-3
Manufacturer
Safetec of America, Inc.
Effective date
2024-02-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
61010-6103, SunscreenSafetec of America, Inc.2024-02-08HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-6103-0Sunscreen3.5 g in 1 PACKETLOTION3.56
61010-6103-1Sunscreen25 in 1 BOXLOTION256
61010-6103-2Sunscreen2 g in 1 PACKETLOTION26
61010-6103-3Sunscreen25 in 1 BOXLOTION256

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-6103SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]6Current NDC, Legacy NDC, 4 package rows20240214_754186c8-3c88-40a0-a4e3-35e3ea9d1b4c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HomosalateACTIVE INGREDIENTV06SV4M95SSUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]4
OctinoxateACTIVE INGREDIENT4Y5P7MUD51SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]4
OctisalateACTIVE INGREDIENT4X49Y0596WSUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]4
OxybenzoneACTIVE INGREDIENT95OOS7VE0YSUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]4
HomosalateACTIVE MOIETYV06SV4M95SSUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]4
OctinoxateACTIVE MOIETY4Y5P7MUD51SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]4
OctisalateACTIVE MOIETY4X49Y0596WSUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]4
OxybenzoneACTIVE MOIETY95OOS7VE0YSUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]4
cetyl alcoholINACTIVE INGREDIENT936JST6JCNSUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]4
diazolidinyl ureaINACTIVE INGREDIENTH5RIZ3MPW4SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]4
dimethiconeINACTIVE INGREDIENT92RU3N3Y1OSUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]4
edetate sodiumINACTIVE INGREDIENTMP1J8420LUSUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]4
methylparabenINACTIVE INGREDIENTA2I8C7HI9TSUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]4
petrolatumINACTIVE INGREDIENT4T6H12BN9USUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]4
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQSUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]4
polyoxyl 40 stearateINACTIVE INGREDIENT13A4J4NH9ISUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]4
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MSUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]4
povidone K30INACTIVE INGREDIENTU725QWY32XSUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]4
propylene glycolINACTIVE INGREDIENT6DC9Q167V3SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]4
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHSUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]4
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XSUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]4
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPSUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]4
waterINACTIVE INGREDIENT059QF0KO0RSUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]4
xanthan gumINACTIVE INGREDIENTTTV12P4NEESUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]4

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 7 of 433 · 8,651 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
application number: M020
unii: 15FIX9V2JP
ISNTREE HYALURONIC ACID WATERY SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEISNTREE Inc.59ac747a-f9c7-2c18-e063-6394a90a23062026-08-23WarningsExact identifier
application number: M020
unii: V06SV4M95S
unii: 4X49Y0596W
ClaravieZINC OXIDE, DIMETHICONEGentell LLC598a5c0b-1e2f-1335-e063-6394a90ac4f42026-08-21WarningsExact identifier
unii: 92RU3N3Y1O
Sunski Sol Power Daily Face Sunscreen SPF 50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEStewart Charley Ventures, LLCb6c3d6b1-3d8a-43c0-aac5-07fe60afbd8c2026-08-21WarningsExact identifier
application number: M020
unii: V06SV4M95S
unii: 4X49Y0596W
HAWAIIAN TROPICAVOBENZONE, HOMOSALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC5990fe66-4fa2-06aa-e063-6294a90a52612026-08-21WarningsExact identifier
application number: M020
unii: V06SV4M95S
Hawaiian TropicAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC5991466a-e729-16b7-e063-6394a90a11ff2026-08-21WarningsExact identifier
application number: M020
unii: V06SV4M95S
unii: 4X49Y0596W
HyVee Ultra Strength Gas Relief SOFTGELSIMETHICONEHyVee Inc49808dc8-a26e-49f4-e063-6294a90a47962026-08-21WarningsExact identifier
unii: 92RU3N3Y1O
Mederma PMDIMETHICONEL Perrigo Company8c728904-28f4-4333-a9ea-20996fd1b0072026-08-21WarningsExact identifier
unii: 92RU3N3Y1O
HyVee Extra Strength Gas Relief SOFTGELSIMETHICONEHyVee Inc496dd780-fe7c-ced6-e063-6294a90aa5982026-08-21WarningsExact identifier
unii: 92RU3N3Y1O
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATETopco Associates LLC597b78df-83cb-1b21-e063-6294a90a56a82026-08-20Warnings, Adverse reactionsExact identifier
application number: M020
unii: V06SV4M95S
unii: 4X49Y0596W
Sunski Base Camp Face and Body Sunscreen SPF 45HOMOSALATE, OCTISALATE, AVOBENZONEStewart Charley Ventures, LLC2fc45f85-a6f8-4893-8b34-4db5e39cb6152026-08-20WarningsExact identifier
application number: M020
unii: V06SV4M95S
unii: 4X49Y0596W
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
application number: M020
unii: 15FIX9V2JP
SunscreenBROAD SPECTRUM SPF 30Concierge Choice LLC5980055b-493e-4763-e063-6294a90a570f2026-08-20WarningsExact identifier
application number: M020
unii: 4X49Y0596W
Mag-AL PlusALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONEPAI Holdings, LLC dba PAI Pharma896ab07a-1b40-43ab-8589-3be86b1c41982026-08-19WarningsExact identifier
unii: 92RU3N3Y1O
Claravie Skin Repair CreamDIMETHICONEGentell LLC596ae269-172e-aef5-e063-6394a90a4e2a2026-08-19WarningsExact identifier
unii: 92RU3N3Y1O
Lip Balm SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENESkin Script, LLC20c5fde7-ee8f-4b74-e063-6394a90a93ec2026-08-19WarningsExact identifier
application number: M020
unii: 4X49Y0596W
unii: 4Y5P7MUD51
Aloe UP .5OZ SPF 50 MINERAL SunscreenZINC OXIDE 14.69%Aloe Care International, LLC6ad80af3-78cd-4211-a5f2-68531aae264a2026-08-19WarningsExact identifier
application number: M020
Utu Broad Spectrum SPF 50 Tinted Sunscreen-StickZINC OXIDEUtu Co596e17d3-3064-1cda-e063-6294a90af9632026-08-19WarningsExact identifier
application number: M020
Mineral sunscreenMINERAL SUNSCREENGuangzhou Origin Beauty Cosmetics Co., Ltd.59713657-a7ef-1aee-e063-6394a90a326e2026-08-19WarningsExact identifier
application number: M020

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.