FDA.reportPublic FDA data

Lip Shine SPF35 Sunscreen

Product NDC
68078-028
11-digit product format
680780028
Labeler code
68078
Product ID
68078-028_10c37e69-e203-43fb-a8c3-50be826a74f1
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LIQUID
Route
TOPICAL
Labeler
Colorescience
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-07-01
Substance
ZINC OXIDE
Active strength
66 mg/mL
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
Lip Shine SPF35 Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE66 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3a6506c4-1ba9-493a-a4c8-e5f9c60d221bAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68078-028-012021-10-08Lip Shine SPF35 Sunscreen
68078-028-022021-10-08Lip Shine SPF35 Sunscreen
68078-028-012021-01-29Lip Shine SPF35 Sunscreen
68078-028-022021-01-29Lip Shine SPF35 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68078-028-01Lip Shine SPF35 Sunscreen4 mL in 1 TUBE, WITH APPLICATORLIQUID43
68078-028-01Lip Shine SPF35 Sunscreen1 in 1 CARTONLIQUID13
68078-028-02Lip Shine SPF35 Sunscreen1.7 mL in 1 TUBE, WITH APPLICATORLIQUID1.73

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68078-028LIP SHINE SPF35 SUNSCREEN (ZINC OXIDE) LIQUID [COLORESCIENCE]3Current NDC, Legacy NDC, 3 package rows20241215_3a6506c4-1ba9-493a-a4c8-e5f9c60d221b.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 109 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bella Blue Skin Care Tinted SunscreenZINC OXIDEBELLA BLU STUDIOS INC3f663fe5-fdfe-d793-e063-6394a90a4f0b2025-12-17WarningsExact identifier
application number: M020
Tinted Daily Mineral ShieldZINC OXIDESIGNATURE MED SPA MT LLC3aadc018-edbb-033b-e063-6394a90afbe72025-12-17WarningsExact identifier
application number: M020
Non-Tinted Daily Mineral ShieldZINC OXIDESIGNATURE MED SPA MT LLC3ab0298d-b2d0-591e-e063-6394a90a31772025-12-17WarningsExact identifier
application number: M020
Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY MINDY LLC3cce3120-748e-a7fd-e063-6394a90a4d512025-12-17WarningsExact identifier
application number: M020
Mineral Sunscreen 20percent Zinc OxideZINC OXIDEESTHETICS BY MINDY LLC3ccea6c0-8c27-6b26-e063-6294a90a09312025-12-17WarningsExact identifier
application number: M020
Non Tinted Mineral Sunscreen 20Percent Zinc OxideZINC OXIDEJKH Aesthetics LLC369c1d16-5980-e1dc-e063-6394a90a31042025-12-17Exact identifier
application number: M020
Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY MINDY LLC3d5a2662-02e3-3a95-e063-6294a90a81202025-12-17WarningsExact identifier
application number: M020
Mineral Sunscreen 20percent Zinc OxideZINC OXIDEESTHETICS BY MINDY LLC3d5ab3f6-10b9-2a21-e063-6294a90a34282025-12-17WarningsExact identifier
application number: M020
Daily Defense Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJKH Aesthetics LLC369ccb8f-d9b6-1fd2-e063-6394a90ace202025-12-17Exact identifier
application number: M020
Royal ScreenZINC OXIDEQUEENIES BEAUTY LLC364cafdd-fe86-cb23-e063-6394a90afb092025-12-17Exact identifier
application number: M020
Royal ScreenZINC OXIDEQUEENIES BEAUTY LLC364d2231-3db3-0a59-e063-6394a90a67772025-12-17Exact identifier
application number: M020
Mattifying Mineral SPF40 TintedTITANIUM DIOXIDE, ZINC OXIDEELIZA ARAKELIAN36d4f6a7-1115-1efa-e063-6294a90a20c42025-12-17Exact identifier
application number: M020
Replenish SPF 40ZINC OXIDEELIZA ARAKELIAN36d69eb5-597d-14a0-e063-6394a90a0a492025-12-17Exact identifier
application number: M020
Mattifying Mineral SPF 40 TintedTITANIUM DIOXIDE, ZINC OXIDEELIZA ARAKELIAN36d45700-fc41-ef54-e063-6394a90abcc32025-12-17Exact identifier
application number: M020
Gentle Mineral SPF 40 TintedZINC OXIDEELIZA ARAKELIAN36d66cde-1f90-32b5-e063-6294a90acb342025-12-17Exact identifier
application number: M020
Replenish SPF 40ZINC OXIDEELIZA ARAKELIAN36d7148b-b1c4-a6a9-e063-6294a90af92f2025-12-17Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHSC MIAMI, INC36d85902-fbd2-ba74-e063-6294a90acfc32025-12-17Exact identifier
application number: M020
DAY DEFENSETITANIUM DIOXIDE, ZINC OXIDETHE SKIN CARE SOURCE, INC.36ad1330-a8bf-e8f8-e063-6394a90acb022025-12-17Exact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHSC MIAMI, INC36d9a8f3-7760-57f3-e063-6394a90a1a1e2025-12-17Exact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHSC MIAMI, INC36d7a18b-5a12-84a9-e063-6394a90a7e382025-12-17Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68078-028-01680780028011 TUBE, WITH APPLICATOR in 1 CARTON (68078-028-01) / 4 mL in 1 TUBE, WITH APPLICATOR2017-07-010000-00-00NoNoCurrent
68078-028-02680780028021.7 mL in 1 TUBE, WITH APPLICATOR (68078-028-02) 1.7 ml2017-07-010000-00-00NoNoCurrent