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
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
SUN THERAPE FACE AND BODY
Brand name suffix
SPF-35
Listing expiration
2026-12-31

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 76 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior824c5f13-970e-4e9e-8f2a-2a01973d2e592026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb7621ef5-47fc-4ccc-aedd-eac328ace7b92026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3C CoolOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior64a29ff8-e24d-4818-9b54-734a0eb2a13f2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2WP Warm PeachOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior17a0201b-b797-4e65-838f-1ce8d408a0202026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2WO Warm OliveOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior72e2c71a-da1d-497f-a8b7-491cff951c632026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior19d1432a-96b0-4cef-b13e-895dd41b41d62026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5a06c820-ccd8-47ce-8bbf-7e90da92b1de2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior205e195a-fd30-44f7-9294-e701f0f766d62026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3WP Warm PeachOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5495ff75-0c83-4491-8af7-4aed7a779d7f2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3WO Warm OliveOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior10bc345d-a5b1-4b70-bfa6-a2d7816904bf2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior30268b6e-d42a-4314-b82f-24f9e81cca2a2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior545c962f-2a59-4d94-8fef-ebdba4127f422026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4C CoolOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior17c9226b-459c-42fe-ac50-7e26db6b49af2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior8cb27c4e-b2f4-4e60-a5ff-7cdda79a3af62026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorbf323e10-5479-44b3-b4b9-b8ca6b0f76882026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4WO Warm OliveOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior2d6a5133-b847-4ecf-8c33-1cb05aca6b912026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4WP Warm PeachOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior275be888-2c52-43ed-846a-55525002edcd2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 6,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc73576a6-dbab-4205-add5-876a060b50222026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 7,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior4ae761ac-df06-4913-a8bf-8ca1be32b5b72026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior72c45120-6997-4250-b9b4-1cdb762efe1a2026-01-16WarningsExact 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