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 210 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Noevir Raysela UV Shield PrimerZINC OXIDE, OCTINOXATENippon Shikizai, Inc.45030b2f-21cf-4285-af12-87ea8f0b8df72025-05-14WarningsExact identifier
application number: M020
OS-01 Lip SPF BS SPF15ZINC OXIDEONESKIN INC.351d55f6-fcd9-1d47-e063-6294a90a2cf02025-05-14WarningsExact identifier
application number: M020
NATUREWELL HYDRASUN LIP BALM SPF30 MINT BREEZE SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LIP BALMPort Jervis Laboratories, Inc.350cd329-8fe2-314f-e063-6394a90ac9542025-05-13WarningsExact identifier
application number: M020
Lancer Mineral Sun Shield Universal Tint Broadspectrum SPF 30ZINC OXIDELancer Skincare LLC522a9158-2fd1-4634-adef-2ba84c86bcd72025-05-13WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENENavajo Manufacturing Company Inc.33f13aa4-9279-c251-e063-6294a90a2d672025-05-12WarningsExact identifier
application number: M020
OS-01 FACE SPF BS SPF 30 TINTED DEEPZINC OXIDEAllure Labs34f51ff4-541d-2b2e-e063-6394a90a39da2025-05-12WarningsExact identifier
application number: M020
Bright Guard Natural SPF 30ZINC OXIDERenu Laboratories, LLCe7035fcd-6894-3360-e053-2a95a90a6f1d2025-05-12WarningsExact identifier
application number: M020
Bright Guard Sport SPFZINC SPFRENU LABORATORIES, LLCc9b48a9e-d69f-65a7-e053-2995a90a0baf2025-05-12WarningsExact identifier
application number: M020
OS-01 FACE SPF BD SPF 30 TINTED MEDIUM/DEEPZINC OXIDEAllure Labs34f674c1-5d59-915a-e063-6394a90a6c2f2025-05-12WarningsExact identifier
application number: M020
Meaningful Beauty Cindy Crawford Skin Brightening Decollete and Neck Treatment Broad Spectrum SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE AND OXYBENZONEMeaningful Beauty, LLCf59fe019-569b-49ba-accf-fa4d356ce96b2025-05-12WarningsExact identifier
application number: M020
Cicatricure Gold Lift SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGenomma Lab USA34cc5b3c-af36-e202-e063-6294a90a13a72025-05-10WarningsExact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b6aa46-657b-2676-e063-6294a90abadd2025-05-09Exact identifier
application number: M020
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a5a99f-9e22-52ab-e063-6294a90a93232025-05-08Exact identifier
application number: M020
PowderTITANIUM DIOXIDEOxygen Development LLC08b7eeeb-09ae-ffe6-e063-6294a90aba902025-05-07WarningsExact identifier
application number: M020
cle de peau BEAUTE UV PROTECTIVE NAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporationfe19a057-a3c6-4c53-92f9-a4a960cd5b082025-05-07WarningsExact identifier
application number: M020
Winter Survival KitOCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEDuke Cannon Supply Co.2487ab56-7856-66b0-e063-6394a90a9d872025-05-07WarningsExact identifier
application number: M020
OS-01 Lip SPF BS SPF15ZINC OXIDEAllure Labs3490ed60-60b9-dfcd-e063-6394a90ab17a2025-05-07WarningsExact identifier
application number: M020
Lip Love Moisture Balm SPF30 - Nude BeigeZINC OXIDEKoco Life LLC3491084b-348a-f2bf-e063-6394a90abd252025-05-07WarningsExact identifier
application number: M020
Lip Love Moisture Balm SPF30 - WatermelonZINC OXIDEKoco Life LLC3491fb2a-d55f-1736-e063-6294a90a594a2025-05-07WarningsExact identifier
application number: M020
Abib Heartleaf mild sunscreen Relief tubeZINC OXIDEFOURCOMPANY CO., LTD.34965587-c9b7-4066-e063-6394a90ab4242025-05-07WarningsExact 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