FDA.reportPublic FDA data

CVS Health 50 Clear Zinc Broad Spectrum SPF 50 Sunscreen

Product NDC
51316-043
11-digit product format
513160043
Labeler code
51316
Product ID
51316-043_24af5a00-b01b-5d28-e063-6394a90a55ba
Type
HUMAN OTC DRUG
Nonproprietary name
OCTOCRYLENE, ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
CVS PHARMACY
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-10-03
Substance
ZINC OXIDE; OCTOCRYLENE
Active strength
50; 40 mg/mL; mg/mL
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
CVS Health 50 Clear Zinc Broad Spectrum SPF 50 Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE50 mg/mL
OCTOCRYLENE40 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal 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
fa19e9d3-6ab8-cbd6-e053-6294a90aae9bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-043-13CVS Health 50 Clear Zinc Broad Spectrum SPF 50 Sunscreen118 mL in 1 TUBELOTION1182
51316-043-85CVS Health 50 Clear Zinc Broad Spectrum SPF 50 Sunscreen59 mL in 1 JARLOTION592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-043CVS HEALTH 50 CLEAR ZINC BROAD SPECTRUM SPF 50 SUNSCREEN (OCTOCRYLENE, ZINC OXIDE) LOTION [CVS PHARMACY]2Current NDC, 2 package rows20241019_fa19e9d3-6ab8-cbd6-e053-6294a90aae9b.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 217 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DECORTE SUN SHELTER MULTI PROTECTION Sunscreen SPF 50 Broad SpectrumAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATEKOS America, Inc.2b41c17d-1394-0c2f-e063-6394a90a0c492025-04-15WarningsExact identifier
application number: M020
Urban Antioxidant Sunscreen SPF 40HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXYIDE CREAMDr. Loretta, LLC930150a3-08bb-17fd-e053-2995a90a786b2025-04-15WarningsExact identifier
application number: M020
Cicapair Soothing Color Correcting Treatment Cica Complex Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEHave & Be Co., Ltd.32c1aba6-5e29-aba9-e063-6394a90a8e562025-04-14WarningsExact identifier
application number: M020
REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRYOCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC07701e11-8a7e-44c5-b46e-5b48264eacad2025-04-14WarningsExact identifier
application number: M020
Dr.Ceuracle HYDRA BARRIER SUNSCREENZINC OXIDELeegeehaam Cosmetics22c05215-4983-b32e-e063-6394a90a9f672025-04-13WarningsExact identifier
application number: M020
No7 Protect and Perfect Intense Advanced Day Cream SPF 30AVOBENZONE,OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS3285e28d-5716-b576-e063-6294a90a89052025-04-11WarningsExact identifier
application number: M020
No7 Protect and Perfect Intense Advanced Fragrance Free Day Cream SPF 30AVOBENZONE,OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS32876315-f81f-fdd2-e063-6394a90ad5f72025-04-11WarningsExact identifier
application number: M020
No7 Future Renew Damage Reversal Day Cream Sunscreen Broad Spectrum SPF 25AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS3287ae2e-759e-31c5-e063-6394a90a892f2025-04-11WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Fragrance Free Day Cream SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS32b5a19e-86d4-5ee1-e063-6394a90a12e22025-04-11WarningsExact identifier
application number: M020
LERINN ZINCPURE SUNMILK SPF 50ZINC OXIDESerrina Lin Skincare Inc32717b49-729c-a229-e063-6394a90a18fb2025-04-10WarningsExact identifier
application number: M020
Smoothing Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEDANIEL BEHROOZAN MD A MEDICAL CORPORATION327246c2-9d7a-2d34-e063-6294a90a5fb72025-04-10Exact identifier
application number: M020
Clarity Rx Physical Skin Defense SPF 50ZINC OXIDE AND TITANIUM DIOXIDETopiderm, Inc.b5111012-97b9-4908-95a0-d09595f9c4d92025-04-10WarningsExact identifier
application number: M020
Tinted Mineral Sunscreen SPF 50ZINC OXIDE AND TITANIUM DIOXIDETopiderm, Inc.13e5085f-df2b-46b2-b063-e58ce43799052025-04-09WarningsExact identifier
application number: M020
Sunstation Sport Sunscreen SPF 30OCTOCRYLENE, ZINC OXIDE, OCTISALATESunstation USA LLC6007c125-f28a-45e5-b8f1-490ee04b78112025-04-09WarningsExact identifier
application number: M020
Pacifica Sun Dreams Illuminating SPF FoamHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEPacifica Beauty, LLC2e0cb105-75c3-8032-e063-6394a90ab5022025-04-09WarningsExact identifier
application number: M020
belif Aqua bomb - glow sunstick SPF50HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANELG H&H CO., LTD.284cadf1-deb9-4f3d-e063-6394a90ab1222025-04-09WarningsExact identifier
application number: M020
ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (ROSA ROMANTICA FEMME) - PINKOCTINOXATE AND OXYBENZONEVentura Corporation LTDaa79b1a4-6b33-47c9-b55e-b813d9b222652025-04-09WarningsExact identifier
application number: M020
Brush On Block SPF 30 Mineral Powder Touch of Tan Zinc OnlyZINC OXIDESPF Ventures, LLC3240cbe5-bfc8-17f7-e063-6394a90a1b982025-04-08WarningsExact identifier
application number: M020
ISA KNOX UV SUN PRO 365 Sheer Mineral FaceZINC OXIDELG HOUSEHOLD & HEALTH CARE LTD.2eeac795-b74e-b3a3-e063-6294a90abf522025-04-08WarningsExact identifier
application number: M020
The Face Shop Hydro Sun Barrier 2-in-1 SPF and MoisturizerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG HOUSEHOLD & HEALTH CARE LTD.2ee9f271-b508-2304-e063-6294a90a37522025-04-08WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-043-1351316004313118 mL in 1 TUBE (51316-043-13) 118 ml2018-10-03NoNoCurrent
51316-043-855131600438559 mL in 1 JAR (51316-043-85) 59 ml2018-10-03NoNoCurrent