FDA.reportPublic FDA data

JACKET SPF-50 Broad Spectrum Sunscreen

Product NDC
71070-868
11-digit product format
710700868
Labeler code
71070
Product ID
71070-868_20ce424e-ca59-9b97-e063-6394a90abfba
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Dosage form
LOTION
Route
TOPICAL
Labeler
BALSHI MD DERMACEUTICALS
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-04-15
Substance
ZINC OXIDE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
60; 100; 50; 50 mg/mL; mg/mL; mg/mL; mg/mL
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 Broad Spectrum Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE60 mg/mL
HOMOSALATE100 mg/mL
OCTISALATE50 mg/mL
OCTOCRYLENE50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fcc45edd-098c-4f27-9712-0db36cfa0fdcAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71070-868-04JACKET SPF-50 Broad Spectrum Sunscreen120 mL in 1 TUBELOTION1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71070-868JACKET SPF-50 BROAD SPECTRUM SUNSCREEN (ZINC OXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [BALSHI MD DERMACEUTICALS]3Current NDC, Legacy NDC, 1 package rows20240830_fcc45edd-098c-4f27-9712-0db36cfa0fdc.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 100 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ageless Glow Serum BB Cream Sunscreen SPF 40 - FairHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC473738b4-7c36-8edf-e063-6394a90ad24b2025-12-30WarningsExact identifier
application number: M020
Ageless Glow Serum BB Cream Sunscreen SPF 40 - Medium TanHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47387d5f-e77b-5633-e063-6294a90a55842025-12-30WarningsExact identifier
application number: M020
Ageless Glow Serum BB Cream Sunscreen SPF 40 - TanHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4738be66-0fe8-148e-e063-6394a90a1b022025-12-30WarningsExact identifier
application number: M020
Ageless Glow Serum BB Cream Sunscreen SPF 40 - Tan DeepHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4738eed1-9f72-5fd8-e063-6394a90a26bd2025-12-30WarningsExact identifier
application number: M020
Ageless Glow Serum BB Cream Sunscreen SPF 40 - DeepHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4739179e-88b3-8820-e063-6394a90aa2112025-12-30WarningsExact identifier
application number: M020
WHITE TEA TINTED MOISTURIZERWHITE TEA TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREENGLOW CONCEPT INCeb2df93f-6cdc-7ae8-e053-2a95a90a00912025-12-29WarningsExact identifier
application number: M020
Hawaiian Natural Zinc Sunscreen SPF 50ZINC OXIDEKokua Sun Care64a5589b-735d-38ba-e053-2a91aa0ad8f42025-12-29WarningsExact identifier
application number: M020
Hawaiian Natural Zinc Sunscreen Broad Spectrum Tinted SPF 30ZINC OXIDEKokua Sun Caref9a12dac-2fd0-798f-e053-6394a90aa7842025-12-29WarningsExact identifier
application number: M020
Calming Days Vegan Sunscreen,OCTYL TRIAZONE (ETHYLHEXYL TRIAZONE), BISOCTRIZOLE, DIETHYLHEXYL BUTAMIDO TRIAZONE, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATEMERCYCO Co., Ltd.38898014-eefe-73ec-e063-6394a90a37382025-12-29WarningsExact identifier
application number: M020
SPF 30 SunscreenZINC OXIDE, TITANIUM DIOXIDECLEUREf5512f34-08ee-b0f6-e053-2a95a90ab5bd2025-12-29WarningsExact identifier
application number: M020
COCO AND EVE SUNNY HONEY PROTECT TAN BOOSTING ANTI-AGING SPF 20SUNSCREEN OILSoleil Collective LLC471b3028-2c13-ab70-e063-6394a90aa6602025-12-29WarningsExact identifier
application number: M020
COCO AND EVE SUNNY HONEY PROTECT TAN BOOSTING ANTI-AGING SPF 45SUNSCREEN OILSoleil Collective LLC471c0eed-f7ca-3c3b-e063-6294a90ad2c62025-12-29WarningsExact identifier
application number: M020
EIGHT HOUR NOURISHING LIP SPF 20OCTINOXATE, AVOBENZONEREVLONb3c16e60-752d-6eba-e053-2995a90a2b202025-12-29WarningsExact identifier
application number: M020
CERAMIDE PREMIERE BROAD SPECTRUM SPF 30OCTINOXATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONEREVLONb3358bfd-7fe5-33e2-e053-2a95a90ac2ea2025-12-29WarningsExact identifier
application number: M020
Prevage anti aging SPF 30OCTISALATE, OCTINOXATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE,Revlonb2bff796-1579-2686-e053-2995a90ad6c72025-12-29WarningsExact identifier
application number: M020
FLAWLESS FUTURE SPF 30OCTINOXATE, OCTISALATE, OXYBENZONE, AVAOBENZONEREVLONb553aec1-5002-3a3f-e053-2995a90a22e52025-12-29WarningsExact identifier
application number: M020
Prevage Anti-aging eye cream SPF 15OCTINOXATE, OXYBENZONERevlonb2a92d72-e634-7379-e053-2995a90a2bca2025-12-29WarningsExact identifier
application number: M020
Prevage Anti-aging Moisture CreamOCTINOXATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONERevlon Consumer Products Corpb247adbe-dfe8-df0a-e053-2995a90a34d92025-12-29WarningsExact identifier
application number: M020
Sheer Protection SPF 30ZINC OXIDESkin Script, LLC0450dcc9-3f8f-e2c2-e063-6294a90af60b2025-12-29WarningsExact identifier
application number: M020
RE-NUTRIV ULTRA RADIANCE MAKEUP BROAD SPECTRUM SPF 20OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC897b8edb-f089-4a49-baca-e05806b0a0682025-12-29WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71070-868-0471070086804120 mL in 1 TUBE (71070-868-04) 120 ml2019-04-150000-00-00NoNoCurrent