FDA.reportPublic FDA data

Vacation X AZ Lemon Tea Lip Balm SPF 30

Product NDC
80641-105
11-digit product format
806410105
Labeler code
80641
Product ID
80641-105_b534b67f-bb13-493c-9f99-be20cf1fae35
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, and Octocrylene
Dosage form
LIPSTICK
Route
TOPICAL
Labeler
Vacation INC.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-01-15
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30; 50; 30; 100 mg/g; mg/g; mg/g; mg/g
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
Vacation X AZ Lemon Tea Lip Balm SPF 30
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/g
HOMOSALATE50 mg/g
OCTISALATE30 mg/g
OCTOCRYLENE100 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
61c48acc-f589-40d3-b289-b777db5551dbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80641-105-01Vacation X AZ Lemon Tea Lip Balm SPF 304.25 g in 1 TUBELIPSTICK4.251

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 161 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Soft Bisque Perfecting Makeup SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Ince8b11940-6ac4-4c80-a732-2f86f2b7ebfe2025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Alabaster Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Incd54a35a2-4f5d-4aec-8be4-1d8e00d4618f2025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Alabaster Beige Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Incd6be5b8e-0094-40de-91a6-bc52b3f8a9872025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Creamy Beige Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Incda149594-8a75-4b8d-9b6a-068231ce153b2025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Pure Beige Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Inc95821b1c-c894-4b3f-94c2-0083497302032025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Porcelain Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Inccce60274-ef8a-4638-a2c8-e869fc9e2a7c2025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Quiet Rose Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Inc776f5cb5-9d0e-4057-9600-e18b2b8a249a2025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Sandy Beige Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Inc2406806e-f5ff-4c54-bf33-a96afaea1ccc2025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Sesame Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Inc70b94df9-2160-450c-a722-cb842f58c3192025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Simply Beige Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Inc7797fcb4-2080-415a-9b4b-5410518380932025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Soft Bisque Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Ince5a63ffc-32e6-4bb1-907a-8697791f57bf2025-11-19WarningsExact identifier
application number: M020
Vanilla Perfecting Makeup Broad Spectrum SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc98ebaa5c-ba28-4e70-a45c-6545eb756d8f2025-11-19WarningsExact identifier
application number: M020
Softlips VanillaDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company8dff782f-7201-4ad9-94d2-672058f817b82025-11-19WarningsExact identifier
application number: M020
Lanolips Sun Balm Tropical Untinted Lip Balm Broad Spectrum SPF30AVOBENZONE, OXTINOXATE, OCTOCRYLENE, OXYBENZONEBaxter Laboratories Pty. Ltd.43923c68-87ad-1ab7-e063-6394a90adf7a2025-11-18WarningsExact identifier
application number: M020
Illuminizing Blendrops Broad Spectrum SPF 46HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC43e36351-4caf-3393-e063-6394a90a00b12025-11-18WarningsExact identifier
application number: M020
Perfecting Blendrops Broad Spectrum SPF 46HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC43e454cf-dac8-4c2f-e063-6394a90a70972025-11-18WarningsExact identifier
application number: M020
Hill Country Fare Morning Facial Moisturizing with Broad Spectrum SPF 30 SunscreenHOMOSALATE, OCTOCRYLENE, ZINC OXIDEH.E.B.43e55eb7-6572-bd88-e063-6294a90aa7ee2025-11-18WarningsExact identifier
application number: M020
Bare Expert Finish Makeup Broad Spectrum SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Incff396aca-cf64-45f8-ba2e-c4fc55d6484b2025-11-18WarningsExact identifier
application number: M020
ANTI-AGING COMPLEX BROAD SPECTRUM SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEMerle Norman Cosmetics, Inc.d10272ea-aedd-5759-e053-2a95a90a3ab32025-11-18WarningsExact identifier
application number: M020
DAYDREAM Broad Spectrum Sunscreen SPF 40ZINC OXIDEDrmtlgy, LLCbd0981cb-49ce-4eaf-bd9e-db48f56b73142025-11-18WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80641-105-01806410105014.25 g in 1 TUBE (80641-105-01) 4.25 g2022-01-15NoNoCurrent