FDA.reportPublic FDA data

MediChoice Moisturizing Lip Balm SPF15

Product NDC
39892-0940
Requested package NDC
39892-0940-3
11-digit product format
398920940
Labeler code
39892
Product ID
39892-0940_40b41656-3e4a-5597-e063-6394a90a952a
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE
Dosage form
CREAM
Route
TOPICAL
Labeler
O&M HALYARD, INC.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-12-22
Substance
AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE
Active strength
30; 65; 50; 15 mg/g; mg/g; mg/g; mg/g
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
MediChoice Moisturizing Lip Balm SPF15
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/g
OCTINOXATE65 mg/g
OCTISALATE50 mg/g
OCTOCRYLENE15 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
00327815-28f0-4198-bca7-c8ae768ff416Available 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
39892-0940-1MediChoice Moisturizing Lip Balm SPF154.2 g in 1 POUCHCREAM4.23
39892-0940-2MediChoice Moisturizing Lip Balm SPF15100 in 1 BOXCREAM1003
39892-0940-2MediChoice Moisturizing Lip Balm SPF154.2 g in 1 CASECREAM4.23
39892-0940-3MediChoice Moisturizing Lip Balm SPF154.2 g in 1 CASECREAM4.23
39892-0940-3MediChoice Moisturizing Lip Balm SPF15100 in 1 BOXCREAM1003

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 63 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tanri Broad Spectrum SPF 30SUNSCREENI. Shay Cosmetics26d5b9d1-d669-3430-e063-6394a90ad7f22026-02-10WarningsExact identifier
application number: M020
DAILY SUNSCREEN BROAD SPECTRUM SPF 30ZINC OXIDES+9d6ffe56-debc-4ad2-837b-fd7bb091a56f2026-02-09WarningsExact identifier
application number: M020
Alumier MD Clear Shield Broad Spectrum SPF 42 SunscreenTITANIUM DIOXIDE, ZINC OXIDEAlumier Labsa9c970c8-b6e3-b0a1-e053-2a95a90a89c72026-02-09WarningsExact identifier
application number: M020
Solavida Broad Spectrum Mineral Sunscreen SPF 30 - FaceZINC OXIDESolavida, LLC4a694cdf-496b-3bc0-e063-6294a90af0d12026-02-09WarningsExact identifier
application number: M020
numbuzin 9 NAD BIO Super Defense Glow Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBENOW BEAUTY INC32bfb17c-5535-c016-e063-6394a90a18142026-02-09WarningsExact identifier
application number: M020
TRADER JOES SHIMMER SUNSCREEN BROAD SPECTRUM SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETrader Joe's Company4a6b69ed-2739-d22a-e063-6294a90a1e522026-02-09WarningsExact identifier
application number: M020
SUNPLUS LIP LIFESUNSCREENI. Shay Cosmetics26d28286-e812-0fb3-e063-6394a90a338d2026-02-09WarningsExact identifier
application number: M020
NUDESCREEN DEWY ILLUMINATING GLOW SPF 30 - Goddess GlowZINC OXIDE SUNSCREENBentley Laboratories, LLCbb86322d-ff30-4a54-97b5-1be2750671462026-02-06WarningsExact identifier
application number: M020
Hampton Sun SPF 50 MineralZINC OXIDE 19.5% TITANIUM DIOXIDE 4.00%S&C Hampton Sun LLCd6c33436-042e-44e8-8b55-98be6e2468792026-02-06WarningsExact identifier
application number: M020
SHISEIDO WASO COLOR-SMART DAY MOISTURIZEROCTINOXATE, TITANIUM DIOXIDEShiseido Americas Corporationf291f077-1c72-48fc-bb19-c20bdeaaa5962026-02-06WarningsExact identifier
application number: M020
SHISEIDO WASO SHIKULIME COLOR CONTROLAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE,Shiseido Americas Corporationf225a736-2ff7-4084-88a4-a8df5b043cce2026-02-06WarningsExact identifier
application number: M020
SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAmerican Sales Company79dff6ec-d958-4bba-999b-da4aa67519f52026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, Octisalate, OctocryleneSUNSCREENRetail Business Services, LLC1dc325bb-d520-4897-b8f8-3f0ecba2274c2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Sheer Touch Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLCd8a55217-ae50-4c7f-a440-f4de079d08ae2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Sheer Touch Sunscreen SPF 100AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLCf2a4b432-118e-42a4-baeb-90614dccbd062026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLC232ab407-1903-45d8-a2b2-6992ffd30d002026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLC0ccef180-0eb1-cf2b-e063-6394a90adf0c2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Sunscreen for Kids SPF 50AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLC6a455f1a-4285-44c3-820a-85a50d1bbc5b2026-02-06WarningsExact identifier
application number: M020
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLC15bf22f5-a8f5-44bb-b787-2b762b330d612026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLC6d1ad14e-afc6-4676-87d7-3e50e3a02fe92026-02-06Warnings, Adverse reactionsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
39892-0940-339892094003100 CASE in 1 BOX (39892-0940-3) / 4.2 g in 1 CASE100 case2014-12-22NoNoCurrent