FDA.reportPublic FDA data

Total Sun Protection

Product NDC
61352-004
11-digit product format
613520004
Labeler code
61352
Product ID
61352-004_43545da6-6e83-7dc3-e063-6294a90ab889
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Octisalate, Oxybenzone, Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Cosmed Dermaceuticals, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-08-01
Substance
OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE
Active strength
75; 30; 30; 40 mg/g; mg/g; mg/g; mg/g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
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
Total Sun Protection
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE75 mg/g
OCTISALATE30 mg/g
OXYBENZONE30 mg/g
ZINC OXIDE40 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup
95OOS7VE0YInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dbb16ef1-ab8c-4e71-a2a2-a507d104ff0fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61352-004-01Total Sun Protection127.6 g in 1 BOTTLE, PLASTICLOTION127.67

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61352-004TOTAL SUN PROTECTION (OCTINOXATE, OCTISALATE, OXYBENZONE, ZINC OXIDE) LOTION [COSMED DERMACEUTICALS, INC.]5Current NDC, Legacy NDC, 1 package rows20241210_dbb16ef1-ab8c-4e71-a2a2-a507d104ff0f.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 281 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fruit of the Earth Sun Town City SPF 15 SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.c7aaa185-8490-60ec-e053-2995a90adc0d2024-10-17WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Dark Tanning SPF 8 SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.c7aa1e58-f7b3-6b7f-e053-2995a90a957c2024-10-17WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.c7bbad46-5c52-9f1d-e053-2995a90ae1392024-10-17WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Baby SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.c7bdd7a3-2e88-d881-e053-2a95a90a2ef92024-10-17WarningsExact identifier
application number: M020
dermalogica dynamic skin recovery spf 50SUNSCREENDermalogica, LLC051b77ab-6970-48e4-bbfd-c066178ea32e2024-10-17WarningsExact identifier
application number: M020
Hyaluronic MoisturizerOCTINOXATE, OXYBENZONE. AVOBENZONEBentley Laboratories LLC88bd6dff-ba19-4f8f-9432-28398d24f1ab2024-10-16WarningsExact identifier
application number: M020
EQUALINE SPORT CONTINUOUS SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEUnited Natural Foods, Inc. dba UNFIf13feba4-25d8-61d0-e053-2995a90aafa82024-10-16WarningsExact identifier
application number: M020
Equaline Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENEUnited Natural Foods, Inc. dba UNFIf0dda684-b0ed-629c-e053-2995a90a12872024-10-16WarningsExact identifier
application number: M020
EQUALINE SPORT SUNSCREEN CONTINUOUS SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEUnited Natural Foods, Inc. dba UNFIe46d20b3-2897-1370-e053-2a95a90a619c2024-10-16WarningsExact identifier
application number: M020
MEIJER BROAD SPECTRUM SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISLATE, OCTOCRYLENEMEIJER DISTRIBUTION. INC.a71d34d4-a924-6421-e053-2995a90a647e2024-10-16WarningsExact identifier
application number: M020
MEIJER BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEMEIJER DISTRIBUTION, INC.a71bf24f-b923-b81f-e053-2995a90a00722024-10-16WarningsExact identifier
application number: M020
MEIJER KIDS BROAD SPECTRUM SPF 50 MINERAL BASED SUNSCREENOCTINOXATE, OCTISALATE, ZINC OXIDEMEIJER DISTRIBUTION INCa9f4fd45-3bbb-14a7-e053-2995a90ab28f2024-10-16WarningsExact identifier
application number: M020
WEGMANS SPORT CLEAR CONTINUOUS SUNSCREEN SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWEGMANS FOOD MARKETS INCe4b7df52-2bc9-1afc-e053-2a95a90a4f872024-10-16WarningsExact identifier
application number: M020
Wegmans SPORT BROAD SPECTRUM SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWEGMANS FOOD MARKETS INCf12bff9a-bd3c-e35d-e053-2995a90abf172024-10-16WarningsExact identifier
application number: M020
MINERAL SUNSCREEN SPF 50ZINC OXIDE, TITANIUM DIOXIDEWEGMANS FOOD MARKETS INCbfe24f55-d0e5-254a-e053-2995a90a2fd32024-10-16WarningsExact identifier
application number: M020
Wegmans Sport Broad Spectrum SPF 70 Clear Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENEWEGMANS FOOD MARKETS INCe7175821-e514-1bea-e053-2995a90a0c0d2024-10-16WarningsExact identifier
application number: M020
Wegmans Kids and Sport Broad Spectrum SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWEGMANS FOOD MARKETS INCf3463f81-9a65-3796-e053-2995a90a4f802024-10-16WarningsExact identifier
application number: M020
Wegmans Sheer Broad Spectrum SPF 30 Dry Touch SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWEGMANS FOOD MARKETS INCf33248fa-695a-fbef-e053-2a95a90abe352024-10-16WarningsExact identifier
application number: M020
Wegmans Sport Sunscreen Stick SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWEGMANS FOOD MARKETS INCf5671251-e26b-045f-e053-2a95a90adc032024-10-16WarningsExact identifier
application number: M020
Wegmans Kids Sunscreen Stick SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWEGMANS FOOD MARKETS INCf57775c3-5e6c-f47a-e053-2a95a90ab0122024-10-16WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61352-004-0161352000401127.6 g in 1 BOTTLE, PLASTIC (61352-004-01) 127.6 g2018-02-130000-00-00NoNoCurrent