FDA.reportPublic FDA data

Blistex

Product NDC
10157-1171
11-digit product format
101571171
Labeler code
10157
Product ID
10157-1171_5baff49d-911b-4819-8a88-3cb5392f2507
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Octisalate, Avobenzone, and Dimethicone
Dosage form
STICK
Route
TOPICAL
Labeler
Blistex Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-08-22
Substance
HOMOSALATE; OCTISALATE; AVOBENZONE; DIMETHICONE
Active strength
15; 5; 3; 2 g/100g; g/100g; g/100g; g/100g
Pharmacologic classes
Skin Barrier Activity [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
Blistex
Brand name suffix
Five Star Lip Protection Broad Spectrum
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE15 g/100g
OCTISALATE5 g/100g
AVOBENZONE3 g/100g
DIMETHICONE2 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup
92RU3N3Y1OInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
47b57317-7df5-442e-a3a4-1d44fe278ac6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10157-1171-1Blistex Five Star Lip Protection Broad Spectrum1 in 1 BLISTER PACKSTICK12
10157-1171-1Blistex Five Star Lip Protection Broad Spectrum4.25 g in 1 CYLINDERSTICK4.252
10157-1171-2Blistex Five Star Lip Protection Broad Spectrum4.25 g in 1 CYLINDERSTICK4.252
10157-1171-2Blistex Five Star Lip Protection Broad Spectrum2 in 1 BLISTER PACKSTICK22
10157-1171-3Blistex Five Star Lip Protection Broad Spectrum3 in 1 BLISTER PACKSTICK32
10157-1171-3Blistex Five Star Lip Protection Broad Spectrum4.25 g in 1 CYLINDERSTICK4.252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10157-1171BLISTEX FIVE STAR LIP PROTECTION BROAD SPECTRUM (HOMOSALATE, OCTISALATE, AVOBENZONE, AND DIMETHICONE) STICK [BLISTEX INC.]2Current NDC, Legacy NDC, 6 package rows20241213_47b57317-7df5-442e-a3a4-1d44fe278ac6.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 3 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunski Hot Block Mineral Sunscreen Stick SPF 50ZINC OXIDEStewart Charley Ventures LLC dba Sunski04ecc5e7-0d9e-4bc7-b964-4cbcc6ed06a82026-09-01WarningsExact identifier
application number: M020
Sun Wave Anti Aging Insta Dry SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC7e48a3d2-e453-4733-b42b-8bea804cda592026-09-01WarningsExact identifier
application number: M020
Sun Wave Anti Aging Lite SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC7204c24f-aab6-45eb-9bd4-879f715ba0752026-09-01WarningsExact identifier
application number: M020
Sun Wave Anti Aging Lite SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC7c1e780a-1831-4f49-a92e-e36017d241a22026-09-01WarningsExact identifier
application number: M020
Sun Wave Cross Sport Insta Dry SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLCd45614c8-b09c-417b-b691-082ea21498802026-09-01WarningsExact identifier
application number: M020
Sun Wave Cross Sport Insta Dry SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC999b0b17-be73-4d42-b182-ce038f4933012026-09-01WarningsExact identifier
application number: M020
Sun Wave Cross Sport Insta Dry SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLCadffff46-4cfb-4c0a-b1a6-75220ee193a52026-09-01WarningsExact identifier
application number: M020
Sun Wave Cross Sport Insta Dry SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC13b2b45b-70e1-46ff-8555-48e1fe98c6512026-09-01WarningsExact identifier
application number: M020
Sun Wave Kids Insta Dry SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC5c2a5ca3-e9eb-48ba-8698-592d2c7aa2412026-09-01WarningsExact identifier
application number: M020
Sunceutical SPF 50 Mineral Face CreamZINC OXIDEBaxter Laboratories Pty. Ltd.2c408728-a1de-d51e-e063-6294a90ade0b2026-08-31WarningsExact identifier
application number: M020
SKIN1004 MADAGASCAR CENTELLA HYALU-CICA WATER-FIT SUN SERUM UVBUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENECraver Corporation38d8c1c9-86b5-1edd-e063-6394a90aeb472026-08-30WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID DAILY SUNGELAVOBENZONE, HOMOSALATE, OCTISALATEISNTREE Inc.5a3a17ff-a7fd-f707-e063-6394a90a31822026-08-29WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID NATURAL SUNCREAMZINC OXIDEISNTREE Inc.5a3a59b2-18b6-521b-e063-6294a90a29582026-08-29WarningsExact identifier
application number: M020
Cetaphil Daily Facial Moisturizer with suncreen SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGalderma Laboratories, L.P.f5eb347f-0d46-4de6-8f3f-9010327678ed2026-08-28WarningsExact identifier
application number: M020
Utu Broad Spectrum SPF 30 Moisturizing Body SunscreenZINC OXIDEUtu Co59938ace-c97c-d758-e063-6394a90a77e42026-08-28WarningsExact identifier
application number: M020
Utu Broad Spectrum SPF 30 Moisturizing Face Mineral Zinc Oxide Sunscreen UnscentedZINC OXIDEUtu Co5982e790-7cdb-c96c-e063-6394a90a02d42026-08-28WarningsExact identifier
application number: M020
Utu Hydrating Sun Balm Broad Spectrum SPF 50ZINC OXIDEUtu Co59d1d0ac-2444-d6f9-e063-6294a90ae80c2026-08-28WarningsExact identifier
application number: M020
Hello Bello Mineral Sunscreen SPF 50ZINC OXIDETopiderm, Inc.54f12764-5c37-4a05-bf96-209fedb93fd12026-08-28WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID DAILY SUNGELAVOBENZONE, HOMOSALATE, OCTISALATEISNTREE Inc.5a02c540-5b3b-9379-e063-6294a90a00f62026-08-27WarningsExact identifier
application number: M020
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10157-1171-1101571171011 CYLINDER in 1 BLISTER PACK (10157-1171-1) / 4.25 g in 1 CYLINDER1 cylinder2020-08-220000-00-00NoNoCurrent
10157-1171-2101571171022 CYLINDER in 1 BLISTER PACK (10157-1171-2) / 4.25 g in 1 CYLINDER2 cylinder2020-08-220000-00-00NoNoCurrent
10157-1171-3101571171033 CYLINDER in 1 BLISTER PACK (10157-1171-3) / 4.25 g in 1 CYLINDER3 cylinder2020-08-220000-00-00NoNoCurrent