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 131 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Non Tinted Mineral SunscreenZINC OXIDESPECKTRA6 LLC374e1c8e-5c5c-9198-e063-6294a90a3b882025-12-11Exact identifier
application number: M020
Non Tinted Mineral SunscreenZINC OXIDESPECKTRA6 LLC374f063a-1ea6-2fcc-e063-6394a90ac5742025-12-11Exact identifier
application number: M020
Defend Tinted Mineral SPF 40TITANIUM DIOXIDE, ZINC OXIDESMOOTH ESTHETICS LLC36eb9fc0-25d7-cfb4-e063-6394a90a2e222025-12-11Exact identifier
application number: M020
Sheer Tinted Sunscreen SPF40TITANIUM DIOXIDE, ZINC OXIDESIMPLICITY SKIN, SPA & BOUTIQUE, LLC36ebdb85-ce8a-d7e0-e063-6394a90a22612025-12-11Exact identifier
application number: M020
Solar Shield Face and Body SPF 40ZINC OXIDEBRIGHT SKINCARE, LLC3b138432-19e5-e757-e063-6294a90a4cbe2025-12-11WarningsExact identifier
application number: M020
Solar Shield Primer SPF 40ZINC OXIDEBRIGHT SKINCARE, LLC3b149758-bbe1-bd66-e063-6294a90afe782025-12-11WarningsExact identifier
application number: M020
Solar Shield Face and Body SPF 40ZINC OXIDEBRIGHT SKINCARE, LLC3b14caa3-f58e-b9ab-e063-6394a90a96952025-12-11WarningsExact identifier
application number: M020
Solar Shield Primer SPF 40ZINC OXIDEBRIGHT SKINCARE, LLC3b152e27-3917-eb7e-e063-6394a90a1f432025-12-11WarningsExact identifier
application number: M020
Mineral Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDECOLETTE TOMASI LLC3727b29f-fe51-0b15-e063-6394a90a780b2025-12-11Exact identifier
application number: M020
Daytime Moisture SPF40ZINC OXIDECOLETTE TOMASI LLC372773b6-fc37-c74b-e063-6294a90a7bf22025-12-11Exact identifier
application number: M020
Prevention Acne Safe Facial Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDENY BEAUTY PALACE LLC373c291a-7839-8486-e063-6294a90a5af32025-12-11Exact identifier
application number: M020
Prevention BodyZINC OXIDENY BEAUTY PALACE LLC373cef98-a61d-dd36-e063-6394a90a7c3b2025-12-11Exact identifier
application number: M020
Restore Plus Defense Acne Safe Facial Mineral Sunscreen Lightly TintedZINC OXIDENY BEAUTY PALACE LLC373d1e6c-9c32-20f5-e063-6294a90af86f2025-12-11Exact identifier
application number: M020
Prevention 2 Acne Safe Facial Mineral Sunscreen Non TintedTITANIUM DIOXIDE, ZINC OXIDENY BEAUTY PALACE LLC373c0ab0-8828-542b-e063-6394a90a86332025-12-11Exact identifier
application number: M020
Restore Plus Defense Acne Safe Facial Mineral Sunscreen Lightly TintedZINC OXIDENY BEAUTY PALACE LLC373ddad0-ed33-a233-e063-6294a90a19cd2025-12-11Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDESKINPLICITY STUDIO LLC37263083-b24f-5a71-e063-6294a90aee7d2025-12-11Exact identifier
application number: M020
Prevention Acne Safe Facial Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDENY BEAUTY PALACE LLC373d4fad-141c-0904-e063-6394a90a97592025-12-11Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDESKINPLICITY STUDIO LLC37265b3d-92ef-ef4a-e063-6294a90a8d952025-12-11Exact identifier
application number: M020
Prevention BodyZINC OXIDENY BEAUTY PALACE LLC373d902f-f7b6-298b-e063-6394a90a93072025-12-11Exact identifier
application number: M020
Nourish And DefendZINC OXIDEANASTASIA FOX-TOMYLOVYCH3726c177-2912-a6cc-e063-6394a90a00432025-12-11Exact 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