FDA.reportPublic FDA data

SUN THERAPE FACE AND BODY

Product NDC
67879-309
11-digit product format
678790309
Labeler code
67879
Product ID
67879-309_1f947bfc-53ab-1cbe-e063-6294a90aebb1
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE
Dosage form
LOTION
Route
TOPICAL
Labeler
PHARMAGEL INTERNATIONAL INC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-06-18
Substance
OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE
Active strength
7.5; 5; 3; 3 g/100mL; g/100mL; g/100mL; g/100mL
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
SUN THERAPE FACE AND BODY
Brand name suffix
SPF-35
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE7.5 g/100mL
OCTISALATE5 g/100mL
OXYBENZONE3 g/100mL
AVOBENZONE3 g/100mL

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
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6a96623f-c37c-4e67-925e-f133461d726dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67879-309-12SUN THERAPE FACE AND BODYSPF-35125 mL in 1 TUBELOTION1258
67879-309-51SUN THERAPE FACE AND BODYSPF-351 in 1 BOXLOTION18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67879-309SUN THERAPE FACE AND BODY SPF-35 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]8Current NDC, Legacy NDC, 2 package rows20240815_6a96623f-c37c-4e67-925e-f133461d726d.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 176 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Baby RoseZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0e9d9419-a7e1-bc42-e063-6394a90af5112025-10-20WarningsExact identifier
application number: M020
ATTITUDE Oceanly Phyto-Sun Tinted Shimmer Cream SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0e8af968-77d5-1dcd-e063-6394a90a66992025-10-20WarningsExact identifier
application number: M020
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Peachy ShellZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0e9e95c3-4ac8-5962-e063-6294a90a0c022025-10-20WarningsExact identifier
application number: M020
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 TerracottaZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0e9dd230-b087-cda7-e063-6394a90ae0842025-10-20WarningsExact identifier
application number: M020
ATTITUDE Oceanly Phyto-Sun Tinted Oil SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0e9b0642-53ed-ec94-e063-6394a90aec3d2025-10-20WarningsExact identifier
application number: M020
ATTITUDE Oceanly Phyto-Sun Tinted Cream SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d977158-8b5d-66ac-e063-6294a90a4d5c2025-10-20WarningsExact identifier
application number: M020
ATTITUDE Oceanly Phyto-Sun Kit SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0eae4b71-60be-9715-e063-6294a90af4632025-10-20WarningsExact identifier
application number: M020
Attitude Oceanly Phyto-Sun Tinted - SPF 15 - Broad Spectrum SunscreenZINC OXIDEAttitude DBA 9055-7588 Qubec Inc.9ed70230-980c-474c-9f72-a6be0f3551242025-10-20WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE OCTISALATE OCTOCRYLENEEdgewell Personal Care Brands LLC419b8043-7921-ca77-e063-6394a90a99ba2025-10-20WarningsExact identifier
application number: M020
Illuminizing Blendrops Broad Spectrum SPF 46HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC419c8718-6b9e-3df7-e063-6294a90a1e3b2025-10-20WarningsExact identifier
application number: M020
Sonni SunDay SerumZINC OXIDESonni419d4ada-fe9b-b774-e063-6394a90a3d092025-10-20WarningsExact identifier
application number: M020
Lip Clear Lysine Plus ColdstickOCTINOXATE AND OXYBENZONEQuantum, Inc.66f84e56-4a5d-4b71-8bd3-79961e7bf4fe2025-10-20WarningsExact identifier
application number: M020
Super Lysine Plus Strawberry Lip TreatmentOCTINOXATE AND OXYBENZONEQuantum, Inc.2cafc97f-4cd3-4755-b394-3802c28d4ed52025-10-20WarningsExact identifier
application number: M020
Super Lysine Plus Tangerine Lip TreatmentOCTINOXATE AND OXYBENZONEQuantum, Inc.8a00194e-9e28-4257-82e5-59bc44f7897d2025-10-20WarningsExact identifier
application number: M020
Super Lysine Plus ColdstickOCTINOXATE AND OXYBENZONEQuantum, Inc.c9318a8c-ba3b-4068-84df-110c9005ee1d2025-10-20WarningsExact identifier
application number: M020
Terez Honor Hydro SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDEWYCREAM INC418d054b-436f-6aa3-e063-6294a90a0f562025-10-19WarningsExact identifier
application number: M020
Danahan Moisture Daily Sunscreen Broad Spectrum SPF 50ENSULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDECosmocos Co., Ltd41129799-85ed-2de2-e063-6394a90ab40c2025-10-17WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCc5a67314-e5b2-4dd6-94e9-39c2f286c3462025-10-17WarningsExact identifier
application number: M020
LION POSE GHOST-BUSTER BROAD SPECTRUM SPF 42 SUNSCREENZINC OXIDELion Pose Inc.0310407b-fb74-aa8b-e063-6294a90ad8412025-10-17WarningsExact identifier
application number: M020
Thrive Daily Defense Sunscreen Balm SPF30ZINC OXIDEThrive Natural Care, Inc1266bd05-1971-a7f0-e063-6394a90a089c2025-10-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67879-309-1267879030912125 mL in 1 TUBE125 mlHistorical
67879-309-51678790309511 TUBE in 1 BOX (67879-309-51) / 125 mL in 1 TUBE (67879-309-12) 1 tube2016-06-100000-00-00NoNoCurrent