FDA.reportPublic FDA data

SUNPLUS LIP LIFE

Product NDC
65112-303
11-digit product format
651120303
Labeler code
65112
Product ID
65112-303_4a6e040a-7781-b1d5-e063-6294a90ae48f
Type
HUMAN OTC DRUG
Nonproprietary name
Sunscreen
Dosage form
STICK
Route
TOPICAL
Labeler
I. Shay Cosmetics
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-01
Substance
OCTOCRYLENE; OCTISALATE; AVOBENZONE; HOMOSALATE
Active strength
.03; .02; .02; .02 g/4.2g; g/4.2g; g/4.2g; g/4.2g
NDC exclude flag
No
Listing certified through
2027-12-31
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
SUNPLUS LIP LIFE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE.03 g/4.2g
OCTISALATE.02 g/4.2g
AVOBENZONE.02 g/4.2g
HOMOSALATE.02 g/4.2g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
26d28286-e812-0fb3-e063-6394a90a338dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65112-303-01SUNPLUS LIP LIFE4.2 g in 1 CONTAINERSTICK4.22
65112-303-02SUNPLUS LIP LIFE1 in 1 BOXSTICK12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65112-303SUNPLUS LIP LIFE (SUNSCREEN) STICK [I. SHAY COSMETICS]1Current NDC, 2 package rows20241115_26d28286-e812-0fb3-e063-6394a90a338d.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 101 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mine Line Coconut Sunscreen SPF 50ZINC OXIDESpa de Soleil4642b1cc-43b1-6997-e063-6394a90ac7642025-12-29WarningsExact identifier
application number: M020
SnugZ SPF 30 Broad Spectrum SunscreenSPF 30 BROAD SPECTRUM SUNSCREENSnugZ/USA, LLC69ac1218-76e6-04ff-e053-2a91aa0a40802025-12-29WarningsExact identifier
application number: M020
SnugZ SPF 50 Sunscreen SprySPF 50 SUNSCREEN SPRAYSnugZ USA9390ea21-9f9f-14e2-e053-2a95a90ac5772025-12-29WarningsExact identifier
application number: M020
SnugZ SPF 15 Flavored Beeswax Lip BalmSPF 15 FLAVORED BEESWAX LIP BALMSnugZ/USA, LLC69bdfaaf-d49e-bf31-e053-2a91aa0affd32025-12-29WarningsExact identifier
application number: M020
SnugZ SPF 50 Broad Spectrum SunscreenSPF 50 BROAD SPECTRUM SUNSCREENSnugZ/USA, LLCb7a3eed5-c8ca-ffda-e053-2a95a90a73bb2025-12-29WarningsExact identifier
application number: M020
SnugZ SPF 15 Beeswax Lip BalmSPF 15 BEESWAX LIP BALMSnugZ/USA, LLC68816d3a-dbe9-7ce3-e053-2a91aa0a395e2025-12-29WarningsExact identifier
application number: M020
SnugZ SPF 30 Soy Lip BalmSPF 30 SOY LIP BALMSnugZ/USA, LLC687ff49d-2d0e-2534-e053-2991aa0a28642025-12-29WarningsExact identifier
application number: M020
SnugZ SPF 50 Sunscreen StickSPF 50 SUNSTICKSnugZ/USA, LLC6e1179cf-5bfb-1156-e053-2991aa0a5b462025-12-29WarningsExact identifier
application number: M020
OUHOE Face Body SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.46d36f60-2a5d-816e-e063-6294a90a2ddc2025-12-26WarningsExact identifier
application number: M020
OUHOE Bean SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.46d3b11f-93d9-0e38-e063-6294a90a41c32025-12-26WarningsExact identifier
application number: M020
CreamZINC OXIDEMONAT GLOBAL CORPe922d89c-4232-77d8-e053-2995a90a85e52025-12-26WarningsExact identifier
application number: M020
CreamZINC OXIDEMONAT GLOBAL CORPe9231470-9292-0e70-e053-2a95a90a767a2025-12-26WarningsExact identifier
application number: M020
CreamZINC OXIDEMONAT GLOBAL CORPe92288bb-739a-2f73-e053-2995a90ac01f2025-12-26WarningsExact identifier
application number: M020
StriVectin-SH NIA-114 UVA UVB Shields SPF 30HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE, OXYBENZONEStriVectin Operating Company Inc.232cbde4-d8ea-4831-9b44-c2e93203260a2025-12-26WarningsExact identifier
application number: M020
CardonAVOBENZONE, HOMOSALATE, OCTYL SALICYLATECardon, Inc72ee2c06-242e-29a2-e053-2991aa0ad8dc2025-12-26WarningsExact identifier
application number: M020
OUHOE Water-Permeable SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.46e63e1e-7851-ca26-e063-6394a90a9b532025-12-26WarningsExact identifier
application number: M020
OUHOE Sun MilkTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.46e678dd-13c5-b317-e063-6294a90aa9892025-12-26WarningsExact identifier
application number: M020
Dermatone Sport SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6%Dermatone Labs LLC0e60e5bb-b941-4114-933a-29480bff59602025-12-24WarningsExact identifier
application number: M020
Intelligent Elixirs Tinted Broad Spectrum SPF 30 - NaturalAVOBENZONE, OCTISALATE, OCTINOXATEIntelligent Elixirs, LLC287a61d8-0056-6211-e063-6394a90aa3da2025-12-24WarningsExact identifier
application number: M020
Sugargirl Glowy SPF 30 Face Screen Sunlight Shimmer Sunscreen for the faceHOMOSALATE,OCTOCRYLENE, OCTISALATE,OCTINOXATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452b5997-d229-60ee-e063-6394a90a68db2025-12-23WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65112-303-01651120303014.2 g in 1 CONTAINER4.2 gHistorical
65112-303-02651120303021 CONTAINER in 1 BOX (65112-303-02) / 4.2 g in 1 CONTAINER (65112-303-01) 1 container2024-06-01NoNoCurrent