FDA.reportPublic FDA data

Sunscreen lip balm

Product NDC
87357-002
11-digit product format
873570002
Labeler code
87357
Product ID
87357-002_48f1ee5c-33d1-818c-e063-6294a90a1e59
Type
HUMAN OTC DRUG
Nonproprietary name
ETHYLHEXYL SALICYLATE
Dosage form
LIPSTICK
Route
TOPICAL
Labeler
Guangdong Zhoubang Biotechnology Co., Ltd
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-22
Substance
BUTYL METHOXYDIBENZOYLMETHANE; ETHYLHEXYL SALICYLATE
Active strength
1; 3 g/100g; g/100g
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
Sunscreen lip balm
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUTYL METHOXYDIBENZOYLMETHANE1 g/100g
ETHYLHEXYL SALICYLATE3 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
48f1ee5c-33d0-818c-e063-6294a90a1e59Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87357-002-01Sunscreen lip balm4.5 g in 1 TUBELIPSTICK4.51

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 321 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gin Amber Beauty Mineral Sunscreen Broad Spectrum SPF 25 BB CreamZINC OXIDEGin Amber Beauty LLC32f48fe4-5788-449e-9ed8-9cd8b2ecc1c02023-11-14WarningsExact identifier
application number: M020
Private Label SPF 50 80 min Water ResistantHOMOSALATE, OCTISALATE, ZINC OXIDE SUNSCREENSwiss-American CDMO, LLC8849fa88-24c8-410d-b16e-60da38288f982023-11-14WarningsExact identifier
application number: M020
Cetaphil Sheer Mineral Face Liquid Sunscreen SPF 50ZINC OXIDEGalderma Laboratories, L.P.0d09b812-b3ca-4214-bed7-7e21ee3288b72023-11-14WarningsExact identifier
application number: M020
DAYWEAR ADVANCED MULTI-PROTECTION ANTI-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF15AVOBENZONE, HOMOSALATE, OCTISALATEESTEE LAUDER INC0a0bfe4a-53b6-5b7c-e063-6394a90a23ec2023-11-13WarningsExact identifier
application number: M020
Bull Frog SPF 50 Mosquito Coast Sunscreen Plus Inspect RepellentAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBULLFROG BRANDS, LLC.f70b39c6-9f40-f5c1-e053-6394a90a1d432023-11-13WarningsExact identifier
application number: M020
Bull Frog SPF 50AVOBENZONE 3.00% HOMOSALATE 15.00% OCTISALATE 5.00% OCTOCRYLENE 10.00%Bullfrog Brands, LLCc90fc29e-d9fe-a6c9-e053-2995a90a69b32023-11-13WarningsExact identifier
application number: M020
Tropical Sands, SPF-50 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.493551d0-10a0-3d78-e054-00144ff8d46c2023-11-11WarningsExact identifier
application number: M020
Tropical Sands SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.494a7886-d677-1648-e054-00144ff8d46c2023-11-11WarningsExact identifier
application number: M020
Tropical Sands SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.ab691543-e37a-487a-912e-56d2e0e4d30a2023-11-11WarningsExact identifier
application number: M020
LBri Pure nNatural Oil Free MoisturizerOCTINOXATE, AVOBENZONE, OCTISALATEL'Bri Health & Beauty47f6ab9e-fa47-496a-e054-00144ff8d46c2023-11-11WarningsExact identifier
application number: M020
PURE HAVEN BODY SPF 30TITANIUM DIOXIDE, ZINC OXIDEPure haven, LLC6f298fcd-8a97-8f66-e053-2991aa0adb102023-11-11WarningsExact identifier
application number: M020
Sunstation All-Natural SPF 30 SunscreenTITANIUM DIOXIDE, ZINC OXIDESunstation USA, LLC499d366a-a7f1-6070-e054-00144ff88e882023-11-11WarningsExact identifier
application number: M020
PURE HAVEN Face Sunscreen SPF-30ZINC OXIDEPure Haven, LLC1fff88a0-4d23-4cd7-872e-1a0b8c6803422023-11-11WarningsExact identifier
application number: M020
Pure Haven EssentialsTITANIUM DIOXIDE, ZINC OXIDEPure Haven LLC4bccc017-266d-11ce-e054-00144ff8d46c2023-11-11WarningsExact identifier
application number: M020
No BS SPF20 MoisturizerOCTINOXATE, AVOBENZONE, OCTOCRYLENEProduct Management LLC690f68fa-d110-4a75-9a14-04aac1be45842023-11-11WarningsExact identifier
application number: M020
koa protect our ocean life OXYBENZONE FREE Broad Spectrum SPF 30 UVA UVB Protection SunscreenTITANIUM DIOXIDE, ZINC OXIDEKapa'ihi, Inc66e5eb1b-4ef0-459d-8428-b3e2f221bc852023-11-11WarningsExact identifier
application number: M020
Sea Star Sparkle SPF-50 PARTY CAKEOCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEMJ Products Association, LLC8cfaf1b6-0f25-4770-9760-2440b2c153b72023-11-11WarningsExact identifier
application number: M020
Sea Star Sparkle SPF-50 VERY BERRYOCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEMJ Products Association, LLC88c403ea-7c78-423e-b05e-1e17c21c5a532023-11-11WarningsExact identifier
application number: M020
FITGLOW Vita Shield Hyaluronic Primer SPF-30ZINC OXIDEFITGLOW BEAUTY LLCb9ba7783-74ca-4736-8a60-1692158590472023-11-11WarningsExact identifier
application number: M020
BLUE MONARCH Tinted SPF-50 (Rose Gold)ZINC OXIDEBlue Monarch, LLC9ba00a03-1015-4946-8c9b-5ef377a32e4b2023-11-11WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87357-002-01873570002014.5 g in 1 TUBE (87357-002-01) 4.5 g2026-01-22NoNoCurrent