FDA.reportPublic FDA data

Chardonnay Lip Oil

Product NDC
80641-012
11-digit product format
806410012
Labeler code
80641
Product ID
80641-012_33139604-3994-e2bf-e063-6294a90a806e
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone Homosalate Octisalate Octocrylene
Dosage form
OIL
Route
TOPICAL
Labeler
Vacation Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-07
Substance
OCTOCRYLENE; AVOBENZONE; OCTISALATE; HOMOSALATE
Active strength
8; 2.9; 4.9; 5 g/100mL; g/100mL; g/100mL; g/100mL
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
Chardonnay Lip Oil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE8 g/100mL
AVOBENZONE2.9 g/100mL
OCTISALATE4.9 g/100mL
HOMOSALATE5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
G63QQF2NOXInternal UNII lookup
4X49Y0596WInternal 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
1318a429-d382-f5b8-e063-6394a90a3bd4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80641-012-01Chardonnay Lip Oil1 in 1 KITOIL14
80641-012-02Chardonnay Lip Oil1 in 1 KITOIL14
80641-012-92Chardonnay Lip Oil8.6 mL in 1 VIALOIL8.64
80641-012-93Chardonnay Lip Oil5.9 mL in 1 VIALOIL5.94

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80641-012CHARDONNAY LIP OIL (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE) OIL [VACATION INC]4Current NDC, 4 package rows20250420_1318a429-d382-f5b8-e063-6394a90a3bd4.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 103 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
G.M. Collin FPS-SPF 50 UVA-UVB TINTED SUNSCREENZINC OXIDE, TITANIUM DIOXIDELABORATOIRES DERMO-COSMETIK INC.468c90d7-3b9e-1641-e063-6394a90a928c2025-12-22WarningsExact identifier
application number: M020
TiZO3TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.468d6476-127a-e9f0-e063-6294a90a3df92025-12-22WarningsExact identifier
application number: M020
YOUR SKIN BUT BETTER FAIRTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC3e65ec1a-0ed9-433d-8da9-a6cb618299112025-12-22WarningsExact identifier
application number: M020
Sun Shades Sunscreen Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMelaleuca Inc.1f982f03-9542-29f9-e063-6294a90a959c2025-12-22WarningsExact identifier
application number: M020
SOLARA SUNCARE - GLOW GETTER SPF-30 NATURALLY SCENTEDZINC OXIDESOLARA SUNCARE, INC.ca99b8c4-6778-43dc-bdd5-ca4a470860a02025-12-22WarningsExact identifier
application number: M020
SOLARA SUNCARE - GO MINERAL DEFENSE SPORT SUPERFRUIT VITAMIN C PLUS ALOE SHEER SUNSCREEN MIST SPF-30 UNSCENTEDZINC OXIDESOLARA SUNCARE, INC.f810843b-5a4d-6cbc-e053-6294a90ac9e32025-12-22WarningsExact identifier
application number: M020
SOLARA SUNCARE - CLEAN FREAK SPF-30 NATURALLY SCENTEDZINC OXIDESOLARA SUNCARE, INC.7a5644b9-4368-4e9a-aa22-b3307acf43cc2025-12-22WarningsExact identifier
application number: M020
MINERAL DEFENSE SPORT CERAMIDE SPF-30ZINC OXIDESOLARA SUNCARE, INC.cbf9c715-2d45-4c1b-b58f-42795722821c2025-12-22WarningsExact identifier
application number: M020
SPF 50 Baby Sunscreen EquateAVOBENZONE, HOMOSALATE, OCTOCRYLENEWalmart Inc4690d89b-ae61-2ed5-e063-6294a90a743f2025-12-22WarningsExact identifier
application number: M020
MINERAL DEFENSE SPORT ANTIOXIDANT FACE SUNSCREEN SPF-50ZINC OXIDESOLARA SUNCARE, INC.f5242c7d-09e1-4141-8de1-a89bd7981ca62025-12-22WarningsExact identifier
application number: M020
SOLARA SUNCARE - TIME TRAVELER SPF-30 UNSCENTEDZINC OXIDESOLARA SUNCARE, INC.f7ad1b52-6d9d-4a12-a6ab-6584ffc39cc92025-12-22WarningsExact identifier
application number: M020
Go Daily Defense Soothing Mineral Face Sunscreen SPF-30ZINC OXIDESOLARA SUNCARE, INC.fd040893-b1e5-783f-e053-6294a90ac2162025-12-22WarningsExact identifier
application number: M020
SOLARA SUNCARE - CLEAN FREAK SPF-30 UNSCENTEDZINC OXIDESOLARA SUNCARE, INC.0fc8fadf-69fc-40ad-b4ca-d96dd2b30f952025-12-22WarningsExact identifier
application number: M020
GUARDIAN ANGEL SUPER PEPTIDE SUNSCREEN MILK SPF-50ZINC OXIDESOLARA SUNCARE, INC.f3bb46e8-a9a5-b184-e053-2995a90afca72025-12-22WarningsExact identifier
application number: M020
SOLARA SUNCARE - POUT PROTECTOR SPF-15ZINC OXIDESOLARA SUNCARE, INC.ab6a326d-3b93-4122-a9f2-05e8203d31ef2025-12-22WarningsExact identifier
application number: M020
SOLARA SUNCARE - FORTUNE TELLER SPF-30ZINC OXIDESOLARA SUNCARE, INC.f434de33-5da8-57ef-e053-2a95a90a85022025-12-22WarningsExact identifier
application number: M020
SPF 50 Kids Sunscreen EquateAVOBENZONE, HOMOSALATE, OCTOCRYLENEWalmart Inc46919f43-2dee-57b1-e063-6294a90a15eb2025-12-22WarningsExact identifier
application number: M020
SPF 30 Sport SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWalmart Inc46919f45-e3f3-4ed0-e063-6294a90a98352025-12-22WarningsExact identifier
application number: M020
Sugargirl Glowy SPF 30 Face Screen daybreak Shimmer Sunscreen for the faceHOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451bb734-d54d-e24e-e063-6394a90a1adb2025-12-21WarningsExact identifier
application number: M020
CabanaClear Illuminating SPF 50HOMOSALATE, OCTISALATE, AVOBENZONENAKED SUNDAYS PTY LTD47d1a39e-f645-c33d-e063-6394a90ad1ef2025-12-21WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80641-012-01806410012011 VIAL in 1 KIT (80641-012-01) / 5.9 mL in 1 VIAL (80641-012-93) 1 vial2024-03-07NoNoCurrent
80641-012-02806410012021 VIAL in 1 KIT (80641-012-02) / 5.9 mL in 1 VIAL (80641-012-93) 1 vial2024-03-07NoNoCurrent
80641-012-92806410012928.6 mL in 1 VIAL (80641-012-92) 8.6 ml2024-03-07NoNoCurrent
80641-012-93806410012935.9 mL in 1 VIAL5.9 mlHistorical