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 173 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MOOYAM Dark Skin SunscreenSUNSCREENGuangdong Bisutang Biotechnology Co., LTD4246e9f1-1c51-d888-e063-6394a90abda02025-10-29WarningsExact identifier
application number: M020
Biossance Squalane and Zinc Sheer Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDETHG Beauty USA LLC1cd10158-c346-60c9-e063-6294a90a54bd2025-10-29WarningsExact identifier
application number: M020
non-tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEClove Hill LLC311b270f-b9e2-2374-e063-6294a90af5812025-10-29WarningsExact identifier
application number: M020
Hello Bello Kids Mineral SunscreenZINC OXIDE TITANIUM OXIDEHello Bello3e7a3e8e-eacf-0a30-e063-6294a90ab7ec2025-10-29WarningsExact identifier
application number: M020
Perricone MD Neuropeptide Restorative Neck and Chest Therapy Broad Spectrum SPF 25TITANIUM DIOXIDETHG Beauty USA LLC23f4cf41-0eed-2df3-e063-6294a90ad4022025-10-28WarningsExact identifier
application number: M020
goPure SunscreenZINC OXIDENatural Lifestyle Brands, LLC dba GoPure beautya74ec20b-8436-4030-820c-01fd88134f402025-10-27WarningsExact identifier
application number: M020
KidsBliss Baby and Kids Mineral Sunscreen SPF50ZINC OXIDEVeganicSKN2dfa236f-128b-17bb-e063-6294a90aa29c2025-10-24WarningsExact identifier
application number: M020
Oze Sun Mineral Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED41dd7477-445f-d1d5-e063-6394a90a46072025-10-24WarningsExact identifier
application number: M020
Oze Sun reef safe Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED41dd936b-0ea6-03a2-e063-6394a90a4fba2025-10-24WarningsExact identifier
application number: M020
Soodox Natural Mineral Sunscreen SPF50 - 6 months to 6 yearsZINC OXIDE SUNSCREENVEGANIC SKN LIMITED41de1cd7-fdfd-7f7a-e063-6394a90a9b5c2025-10-24WarningsExact identifier
application number: M020
Soodox Natural Mineral Sunscreen SPF50 - 7 years to adultZINC OXIDE SUNSCREENVEGANIC SKN LIMITED41de09dc-544f-9780-e063-6394a90acd272025-10-24WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Face Sunscreen SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC23670a30-6619-0651-e063-6394a90af9782025-10-24WarningsExact identifier
application number: M020
PERRICONE MD VITAMIN C ESTER PHOTO-BRIGHTENING MOISTURIZER BROAD SPECTRUM SPF 30TITANIUM DIOXIDETHG Beauty USA LLC397b4338-fec8-5228-e063-6394a90ad97d2025-10-23WarningsExact identifier
application number: M020
Perricone MD HIGH POTENCY CLASSICS Face Finishing and Firming Tinted Moisturizer Broad Spectrum SPF 30TITANIUM DIOXIDETHG Beauty USA LLC38c80373-1d5a-c7f4-e063-6294a90aa9c22025-10-23WarningsExact identifier
application number: M020
Perricone MD Cold Plasma Plus Daily Defense Moisturizer Broad Spectrum SPF 35ZINC OXIDE, TITANIUM DIOXIDETHG Beauty USA LLC254b4692-a459-6119-e063-6394a90a0a602025-10-23WarningsExact identifier
application number: M020
AVOBENZONE,OCTINOXATE,OCTISALATE,OCTOCRYLENECHOP SAVER FRESH CITRUS SPF 15 LIP BALMGood for the Goose Products, LLC2786cec8-0b8e-9c83-e063-6394a90ab3382025-10-23WarningsExact identifier
application number: M020
Calendula Essential Hydrating Broad Spectrum SPF 30 SunscreenZINC OXIDENaturopathica Holistic Health41d75815-e281-bf88-e063-6294a90afeff2025-10-23WarningsExact identifier
application number: M020
Thrive Daily Sunscreen For Sensitive Skin SPF 30ZINC OXIDEThrive Natural Care, Inc128e1a3a-df40-f51c-e063-6394a90a19022025-10-23WarningsExact identifier
application number: M020
Thrive Bodyshield 50 SPF 50ZINC OXIDEThrive Natural Care, Inc12d9e1d0-c59c-f770-e063-6294a90a81912025-10-23WarningsExact identifier
application number: M020
Good Defense Daily Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEOffspring Beauty Co.2a462e60-6353-f791-e063-6294a90a62e32025-10-23WarningsExact 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