FDA.reportPublic FDA data

Sunscreen

Product NDC
75712-950
11-digit product format
757120950
Labeler code
75712
Product ID
75712-950_4c1f5c71-b7c4-a743-e063-6394a90a584b
Type
HUMAN OTC DRUG
Nonproprietary name
Sunscreen
Dosage form
LOTION
Route
TOPICAL
Labeler
Old East Main Co.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-05
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength
30; 120; 50 mg/mL; mg/mL; mg/mL
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
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE120 mg/mL
OCTISALATE50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1673b8b1-08ad-40a5-8180-93333a8edb67Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75712-950-30Sunscreen177 mL in 1 TUBELOTION1773

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75712-950SUNSCREEN LOTION [OLD EAST MAIN CO.]1Current NDC, 1 package rows20241208_1673b8b1-08ad-40a5-8180-93333a8edb67.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 203 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Basin Juicy Watermelon SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a8a093b-cc9c-26fc-e063-6394a90a20282025-07-22WarningsExact identifier
application number: M020
Basin Coconut SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a8a87d6-ef86-60c2-e063-6394a90a07062025-07-22WarningsExact identifier
application number: M020
Basin Eucalyptus Mint SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a8b773c-f456-836a-e063-6294a90a0d462025-07-22WarningsExact identifier
application number: M020
Basin Strawberry SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a8bc90d-350f-98c8-e063-6294a90abd9c2025-07-22WarningsExact identifier
application number: M020
Basin Peach Apricot SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a8bd5d8-1c4c-0407-e063-6394a90a138f2025-07-22WarningsExact identifier
application number: M020
CLEAR GLOW RADIANT SUN SERUM SPF50AVOBENZONE 15MG/G, HOMOSALATE 5MG/G, OCTOCRYLENE 25MG/G, (SUNSCREEN)NAKED SUNDAYS PTY LTDd748e291-3a29-663c-e053-2995a90a8d922025-07-22WarningsExact identifier
application number: M020
La Defense Broad Spectrum SPF 30 Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDELuzern Laboratories, Inc3f00befa-415d-415d-89e1-6ba8770ba51e2025-07-21WarningsExact identifier
application number: M020
PREDIRE PARIS skin shield protector mineral defense creamPREDIRE PARIS SKIN SHIELD PROTECTOR MINERAL DEFENSE CREAMGuangzhou Fantesy Biotechnology Co.,Ltd3a7c1345-532f-b38f-e063-6394a90a52452025-07-21WarningsExact identifier
application number: M020
Medicated Peppermint Lip BalmDIMETHICONE, UNSPECIFIED, OCTINOXATE, AND OCTISALATEBlistex Inc5d48a6fa-ddce-47c3-9b09-1f3abb6950172025-07-18WarningsExact identifier
application number: M020
ICD Moisture Layer SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEICD Moisture Layer Sunscreen3a2a74f2-9fed-808f-e063-6294a90a410c2025-07-18WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 2ZINC OXIDEG2G Ventures, PBC3a35c95b-10eb-689f-e063-6394a90ae1d42025-07-18WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 3ZINC OXIDEG2G Ventures, PBC3a35bbb2-a1eb-346b-e063-6294a90a90782025-07-18WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 4ZINC OXIDEG2G Ventures, PBC3a35f23b-3732-db3c-e063-6294a90ae00c2025-07-18WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 5ZINC OXIDEG2G Ventures, PBC3a35fd79-f4d3-5ccf-e063-6294a90a97982025-07-18WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 6ZINC OXIDEG2G Ventures, PBC3a360053-5863-95fe-e063-6394a90a45c52025-07-18WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 8ZINC OXIDEG2G Ventures, PBC3a362e05-3a1e-8059-e063-6294a90ad5252025-07-18WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 7ZINC OXIDEG2G Ventures, PBC3a3621c2-709a-82fd-e063-6294a90a7a7e2025-07-18WarningsExact identifier
application number: M020
Basin Pina Colada SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc3a39ac31-85c9-5e04-e063-6394a90aa5372025-07-18WarningsExact identifier
application number: M020
Basin American Pink Lemonade SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a3afeda-f235-eac2-e063-6294a90a5a932025-07-18WarningsExact identifier
application number: M020
Basin Chinese Mandarin SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a3b5f56-aa36-01c7-e063-6294a90a6d622025-07-18WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75712-950-3075712095030177 mL in 1 TUBE (75712-950-30) 177 ml2024-12-05NoNoCurrent