FDA.reportPublic FDA data

JACKET SPF 50

Product NDC
71070-768
11-digit product format
710700768
Labeler code
71070
Product ID
71070-768_0974579b-6f81-6b47-e063-6294a90a0217
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE, OCTINOXATE, OCTISALATE, OCTISALATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Balshi MD Dermaceuticals
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-11-18
Substance
ZINC OXIDE; OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength
75; 75; 50; 50 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
JACKET SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE75 mg/g
OCTINOXATE75 mg/g
OCTISALATE50 mg/g
OXYBENZONE50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b82b8a46-8009-416e-8718-296a23106914Available 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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71070-768-04JACKET SPF 501 in 1 CARTONCREAM13
71070-768-04JACKET SPF 50113 g in 1 BOTTLECREAM1133

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71070-768JACKET SPF 50 (ZINC OXIDE, OCTINOXATE, OCTISALATE, OCTISALATE) CREAM [BALSHI MD DERMACEUTICALS]3Current NDC, Legacy NDC, 2 package rows20231106_b82b8a46-8009-416e-8718-296a23106914.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 243 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REVLON AGE DEFYING FIRMING LIFTING MAKEUP SPF 15OCTINOXATE, TITANIUM DIOXIDE MAKE-UPRevlon Consumer Products Corpd9209277-469d-48f4-bf64-f39a70c195962024-12-31WarningsExact identifier
application number: M020
Almay Smart Shade Skintone Matching Makeup LightTITANIUM DIOXIDE ZINC OXIDEAlmay, Inc.2a987b85-efdb-eb95-e063-6394a90aef812024-12-31WarningsExact identifier
application number: M020
ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20 LightTITANIUM DIOXIDE, ZINC OXIDEAlmay, Inc.2a984dd9-7293-77f0-e063-6294a90a8f1e2024-12-31WarningsExact identifier
application number: M020
Vichy Laboratoires Capital Soleil 50 Daily AntiAging Face Sunscreen Broad Spectrum SPF 50 Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc097fc15e-ea17-47b2-9581-19c5e11592f62024-12-30WarningsExact identifier
application number: M020
HERBAL UV DEFENSE SPF40HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENECOSMAX USA, CORPORATION2a76fd94-2f1f-e6d8-e063-6294a90a287c2024-12-30WarningsExact identifier
application number: M020
Almay Healthy Biome MakeupHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEAlmayab20969a-8640-307d-e053-2a95a90a004d2024-12-30WarningsExact identifier
application number: M020
EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUSOCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLEExelencia importers Corp.2a845e4c-86e7-1799-e063-6294a90a9b2b2024-12-30WarningsExact identifier
application number: M020
American Crew All In One Face Balm Broad Spectrum SPF 15OCTISALATE,HOMOSALATE,AVOBENZONE,OCTOCRYLENERevlon Consumer Products Corp012be422-1b4c-443c-9484-02efc744296d2024-12-30WarningsExact identifier
application number: M020
Advanced Ceramide Lift and Firm Day Cream Broad Spectrum Sunscreen SPF 15OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATEREVLON2a857553-5ad0-a0e2-e063-6294a90af4352024-12-30WarningsExact identifier
application number: M020
SkinCeuticals Sheer Physical UV Defense Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc2035ab03-80b4-49f4-b379-eb8bc42c9cee2024-12-30WarningsExact identifier
application number: M020
PRISMA PROTECT SPF30HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEDermalogica, LLC.713bad2e-bf32-4cd5-9630-b8d88d4376862024-12-30WarningsExact identifier
application number: M020
Protection 50 SportHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEDermalogica, LLC.e9ace96a-7717-4f5a-8e1b-1f56f74985992024-12-30WarningsExact identifier
application number: M020
SkinCeuticals Physical Matte UV Defense Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Incb137b3d0-212b-440a-b158-62ace4b4eff32024-12-30WarningsExact identifier
application number: M020
SkinCeuticals Physical UV Defense Broad Spectrum SPF 30 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc3a6db7d3-6c59-4633-a97e-1c03127246d32024-12-30WarningsExact identifier
application number: M020
Dermablend Professional Leg and Body Makeup Broad Spectrum SPF 25 SunscreenOCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incdf62e1c2-ce72-4ded-8985-156dce9ff41d2024-12-28WarningsExact identifier
application number: M020
LOreal Paris Revitalift Derm Intensives Invisible UV Fluid Broad Spectrum SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Inc02dddfc5-61e6-433b-8d6d-a17bf3fc8ed62024-12-28WarningsExact identifier
application number: M020
Vichy Laboratoires Aqualia Thermal UV Defense Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENECosmetique Active Production229eef79-39ae-4395-8100-64d1ece960d22024-12-28WarningsExact identifier
application number: M020
COOLA Mineral Sun Silk Creme Sunscreen SPF 30ZINC OXIDECOOLA LLCbb9dd9a9-ec01-4e94-9172-3a72e68a417a2024-12-27WarningsExact identifier
application number: M020
Bare Republic Mineral SPF 50ZINC OXIDECOOLA LLC6a0db9da-ee45-4ab7-80de-4bf189efe75f2024-12-27WarningsExact identifier
application number: M020
COOLA CLASSIC BODY SUNSCREEN Guava Mango Broad Spectrum SPF 50AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENECOOLA LLC9a397a2c-4734-4dae-93dd-15c68e6c297d2024-12-27WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71070-768-04710700768041 BOTTLE in 1 CARTON (71070-768-04) / 113 g in 1 BOTTLE1 bottle2016-11-180000-00-00NoNoCurrent