FDA.reportPublic FDA data

CVS Health

Product NDC
69842-164
11-digit product format
698420164
Labeler code
69842
Product ID
69842-164_2514730a-9ca2-5e28-e063-6394a90a483d
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
CVS Pharmacy
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-01-26
Substance
OCTOCRYLENE; OCTISALATE; HOMOSALATE; AVOBENZONE; OXYBENZONE
Active strength
100; 50; 150; 30; 60 mg/mL; mg/mL; mg/mL; 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
Brand name suffix
SPF 70 Sun
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE100 mg/mL
OCTISALATE50 mg/mL
HOMOSALATE150 mg/mL
AVOBENZONE30 mg/mL
OXYBENZONE60 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup
V06SV4M95SInternal UNII lookup
G63QQF2NOXInternal UNII lookup
95OOS7VE0YInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
63b420ba-ac69-5670-e053-2a91aa0a864bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-164-11CVS HealthSPF 70 Sun237 mL in 1 BOTTLELOTION2375
69842-164-14CVS HealthSPF 70 Sun473 mL in 1 BOTTLELOTION4735
69842-164-40CVS HealthSPF 70 Sun308 mL in 1 BOTTLELOTION3085

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-164CVS HEALTH SPF 70 SUN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [CVS PHARMACY]5Current NDC, Legacy NDC, 3 package rows20241024_63b420ba-ac69-5670-e053-2a91aa0a864b.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 42 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EltaMD UV Restore TintedTITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENCP Skin Health Group, Inc.6a48ad0d-20e4-44b1-90d6-30bfbc68a1522026-04-17WarningsExact identifier
application number: M020
Pacto Refreshing Sunscreen Broad Spectrum SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENEMynd LLC56ad7c97-3dae-4bac-a677-f5052dfdfea42026-04-16WarningsExact identifier
application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Medium)TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f95cd0a-f996-648b-e063-6294a90adc282026-04-16WarningsExact identifier
application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Tan)TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f968058-e851-86d0-e063-6294a90aa7862026-04-16WarningsExact identifier
application number: M020
Red Cherry SPF 15 Broad Spectrum Lip BalmRED CHERRY SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inc4f96d057-39b8-e4d5-e063-6394a90acb5c2026-04-16WarningsExact identifier
application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Deep)TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f970778-97d6-40a9-e063-6394a90a6c892026-04-16WarningsExact identifier
application number: M020
ZO Skin Health Sheer Fluid Tint Broad-Spectrum Sunscreen SPF 45 Fair-LightZINC OXIDEZO Skin Health, Inc.4f9988a0-ae4a-9940-e063-6294a90ad91d2026-04-16WarningsExact identifier
application number: M020
MELAO Hydrating Mineral SunscreenTITANIUM DIOXIDE,ZINC OXIDEGuangdong Aimu Biological Technology Co., Ltd4f778eb0-55f7-38d0-e063-6394a90a69a02026-04-15WarningsExact identifier
application number: M020
Tanning Club Everyday Sunscreen SPF 30HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONETANNING CLUB, LLC75820400-a5e0-4cf5-8b4f-a52500ce62c32026-04-15WarningsExact identifier
application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f81e482-8111-451c-e063-6294a90ad1482026-04-15WarningsExact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEUNDRBUDR, LLC4f8353b3-4ac1-9703-e063-6294a90abdad2026-04-15WarningsExact identifier
application number: M020
Mineral Sunscreen Stick Non-TintedTITANIUM DIOXIDE, ZINC OXIDEUNDRBUDR, LLC4f83dd76-a8d8-916e-e063-6294a90ab6ed2026-04-15WarningsExact identifier
application number: M020
Mineral Sunscreen Stick - TintedTITANIUM DIOXIDE, ZINC OXIDEUNDRBUDR, LLC4f84619f-3415-7443-e063-6394a90a162a2026-04-15WarningsExact identifier
application number: M020
Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen IvoryTITANIUM DIOXIDE AND ZINC OXIDEPML NYC, LLC1be639a8-179a-7015-e063-6394a90ab64b2026-04-15WarningsExact identifier
application number: M020
PHELITYL DAY SPF 15PHELITYL DAY SPF 15PML NYC, LLCea9d33d9-6f9f-0a66-e053-2a95a90abd422026-04-15WarningsExact identifier
application number: M020
FIRMARINE MOISTURIZER SPF 30FIRMARINE MOISTURIZER SPF 30PML NYC, LLCea9db179-1b69-01e0-e053-2a95a90a16282026-04-15WarningsExact identifier
application number: M020
EVEN TRUE NUTRITIVE SKIN MOISTURIZER SPF 15EVEN TRUE NUTRITIVE SKIN MOISTURIZER SPF 15PML NYC, LLCeaa562b1-3fc6-1a85-e053-2995a90ad1ec2026-04-15WarningsExact identifier
application number: M020
DD Cream Dermatologically Defining BB Cream Broad Spectrum SPF 30DD CREAM DERMATOLOGICALLY DEFINING BB CREAM BROAD SPECTRUM SPF 30PML NYC, LLCea90bb4d-6f4a-45c9-e053-2a95a90a53a72026-04-15WarningsExact identifier
application number: M020
RICH GIRL HAND SPF 25RICH GIRL HANDPML NYC, LLCea8f4421-109f-41a5-e053-2a95a90a38322026-04-15WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- ALABASTERYOUR NAME MINERAL SHEER TINTPML NYC, LLC0e24a63e-d76f-6581-e063-6394a90a61812026-04-15WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-164-1169842016411237 mL in 1 BOTTLE (69842-164-11) 237 ml2018-01-260000-00-00NoNoCurrent
69842-164-1469842016414473 mL in 1 BOTTLE (69842-164-14) 473 ml2018-01-260000-00-00NoNoCurrent
69842-164-4069842016440308 mL in 1 BOTTLE (69842-164-40) 308 ml2022-02-11NoNoCurrent