Hydrating Sheer Lip Balm SPF 30 - SHIMMER

Product NDC
49358-604
11-digit product format
493580604
Labeler code
49358
Product ID
49358-604_36d8ea31-6d00-0d8f-e063-6394a90ae824
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Octisalate, and Homosalate
Dosage form
LIPSTICK
Route
TOPICAL
Labeler
MDSolarSciences
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength
30; 100; 50 mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydrating Sheer Lip Balm SPF 30 - SHIMMER
Brand name suffix
Broad Spectrum SPF 30 UVA-UVB Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/g
HOMOSALATE100 mg/g
OCTISALATE50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, 4X49Y0596W, V06SV4M95S

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49358-604-01Hydrating Sheer Lip Balm SPF 30 - SHIMMERBroad Spectrum SPF 30 UVA-UVB Sunscreen1 in 1 CARTONLIPSTICK12
49358-604-01Hydrating Sheer Lip Balm SPF 30 - SHIMMERBroad Spectrum SPF 30 UVA-UVB Sunscreen4.2 g in 1 APPLICATORLIPSTICK4.22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49358-604HYDRATING SHEER LIP BALM SPF 30 -CRYSTAL BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK HYDRATING SHEER LIP BALM SPF 30 - BARE BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK HYDRATING SHEER LIP BALM SPF 30 - BLUSH BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK HYDRATING SHEER LIP BALM SPF 30 - RUBY BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK HYDRATING SHEER LIP BALM SPF 30 - SHIMMER BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK HYDRATING SHEER LIP BALM SPF 30 - SPICE BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK HYDRATING SHEER LIP BALM SPF 30 - DREAM BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK [MDSOLARSCIENCES]1Current NDC, 2 package rows20230922_0f23441c-2399-4a72-9f0a-420d25db78af.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49358-604-01493580604011 APPLICATOR in 1 CARTON (49358-604-01) / 4.2 g in 1 APPLICATOR1 applicator2023-07-01NoNoHistorical