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 286 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bright as Day Mineral SPF50ZINC OXIDEKoco Life LLC1c245a53-4098-62e6-e063-6294a90abf122024-09-23WarningsExact identifier
application number: M020
Pure Protect Mineral Sunscreen Stick SPF50ZINC OXIDEKoco Life LLC22cd5999-9b9a-91a3-e063-6394a90a0da52024-09-23WarningsExact identifier
application number: M020
ABSOLUTELY natural Lip Balm Broad Spectrum SPF 15 SunscreenZINC OXIDEAbsolutely Naturaleb914dd8-9b11-44dd-8c4f-4d4c0c3bf1ea2024-09-23WarningsExact identifier
application number: M020
SUNSCREEN 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.229dabbc-9043-3c9d-e063-6394a90a56922024-09-21WarningsExact identifier
application number: M020
GLC OG Natural Tinted SPF 30 SunscreenZINC OXIDEGUD LIFE CO. LLC25e1e8ec-e19d-45f7-b339-5d12c2b511d62024-09-18WarningsExact identifier
application number: M020
Target Up and Up Sunscreen SPF 30 SPORT Broad SpectrumAVOBENZONE, HOMOSALATE,OCTISALATE,OCTOCRYLENETARGET CORPORATIONbad7d56e-662e-0776-e053-2a95a90a0af02024-09-18WarningsExact identifier
application number: M020
Target Up and Up Kids SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATIONb82b6d0d-616d-f041-e053-2995a90ae6a32024-09-18WarningsExact identifier
application number: M020
COOLA Dew Good Illuminating Body Melt SPF 40AVOBENZONE, OCTISALATE, OCTOCRYLENECOOLA LLC43d293f6-e13c-4ee9-89df-2a3ef0034e312024-09-16WarningsExact identifier
application number: M020
Proceuticals Private Label by TiZO non-tinted replenishing daily protectionZINC OXIDEFallien Cosmeceuticals, Ltd2203ea22-d12a-99fe-e063-6394a90aca9f2024-09-13WarningsExact identifier
application number: M020
OS-01 Face SPF BS SPF30 TintedZINC OXIDEAllure Labs22042031-ac8e-1ab2-e063-6394a90a6ed42024-09-13WarningsExact identifier
application number: M020
OS-01 Face SPF BS SPF30 TintedZINC OXIDEONESKIN INC.2204e776-b1a1-be15-e063-6294a90af5de2024-09-13WarningsExact identifier
application number: M020
OS-01 Face SPF BS SPF30 UntintedZINC OXIDEAllure Labs2205345b-5e92-37eb-e063-6294a90a6b6c2024-09-13WarningsExact identifier
application number: M020
OS-01 Face SPF BS SPF30 UntintedZINC OXIDEONESKIN INC.2205ec0e-ac3f-299f-e063-6294a90a21742024-09-13WarningsExact identifier
application number: M020
H-E-B SOLUTIONS SUNSCREEN COCONUT SPF 50 CONTINUOUSAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf4130277-ea9b-6b25-e053-2a95a90a59be2024-09-13WarningsExact identifier
application number: M020
HEB SPF 50 Tattoo Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf6df491d-1fa9-a4c8-e053-6394a90a38662024-09-13WarningsExact identifier
application number: M020
YOUR Day Cream Sunscreen Broad Spectrum SPF 30OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENESkin Ai, LLC21cbd5ac-5307-939b-e063-6294a90ac7912024-09-10WarningsExact identifier
application number: M020
Mario Badescu SPF 17AVOBENZONE, OCTINOXATE, OCTOCRYLENEBentley Laboratories LLC0fd51f8d-ee67-48fd-ab98-1fedb03394622024-09-10WarningsExact identifier
application number: M020
Mario Badescu Collagen SPF 15AVOBENZONE, OCTINOXATE, OXYBENZONEBentley Laboratories LLC0246b11b-f1ba-4f47-91ab-52a6554b94672024-09-10WarningsExact identifier
application number: M020
Mario Badescu The Moisture Magnet SPF 15AVOBENZONE, OCTINOXATE, OXYBENZONEBentley Laboratories LLCf6d653f5-52a0-42ad-8308-b8d6f57050cc2024-09-10WarningsExact identifier
application number: M020
MARIO BADESCU SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBentley Laboratories LLCfe485d4c-0ded-4061-ac34-77b72d5350902024-09-10WarningsExact 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