MedPath

CVS SPF 60 Face Sunscreen

CVS SPF 60 Face

Approved
Approval ID

26d1b568-ad9c-80d7-e063-6394a90a2cbf

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 21, 2025

Manufacturers
FDA

CVS

DUNS: 062312574

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Avobenzone, Homosalate, Octisalate, Octocrylene

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51316-922
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Avobenzone, Homosalate, Octisalate, Octocrylene
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 21, 2025
FDA Product Classification

INGREDIENTS (36)

DICAPRYLYL CARBONATEInactive
Code: 609A3V1SUA
Classification: IACT
CETEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
PROPYLENE CARBONATEInactive
Code: 8D08K3S51E
Classification: IACT
P-ANISIC ACIDInactive
Code: 4SB6Y7DMM3
Classification: IACT
DIETHYLHEXYL SYRINGYLIDENEMALONATEInactive
Code: 3V5U97P248
Classification: IACT
OCTYLDODECYL XYLOSIDEInactive
Code: 8Z6VNR46QM
Classification: IACT
DIMETHICONE 200Inactive
Code: RGS4T2AS00
Classification: IACT
ISOSTEARYL ALCOHOLInactive
Code: Q613OCQ44Y
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
DIDECYL ETHERInactive
Code: DA81HI310Z
Classification: IACT
GLYCERYL STEARATE CITRATEInactive
Code: WH8T92A065
Classification: IACT
BEHENYL ACRYLATE POLYMERInactive
Code: D64PM5UT4U
Classification: IACT
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW)Inactive
Code: 5Z4DPO246A
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
PEG-30 DIPOLYHYDROXYSTEARATEInactive
Code: 9713Q0S7FO
Classification: IACT
OCTYLDODECANOLInactive
Code: 461N1O614Y
Classification: IACT
SENNA ALATA LEAFInactive
Code: 4BXR6YZN92
Classification: IACT
LAURYL PEG/PPG-18/18 METHICONEInactive
Code: ZJ5S27D9NX
Classification: IACT
SODIUM DODECYLBENZENESULFONATEInactive
Code: 554127163Y
Classification: IACT
PEG-8 LAURATEInactive
Code: 762O8IWA10
Classification: IACT
SILICAInactive
Code: ETJ7Z6XBU4
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
C12-15 ALKYL BENZOATEInactive
Code: A9EJ3J61HQ
Classification: IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEInactive
Code: C9H2L21V7U
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GLYCERYL BEHENATE/EICOSADIOATEInactive
Code: 73CJJ317SR
Classification: IACT
HECTORITEInactive
Code: 08X4KI73EZ
Classification: IACT
OCTISALATEActive
Quantity: 5 g in 100 mL
Code: 4X49Y0596W
Classification: ACTIB
HOMOSALATEActive
Quantity: 10 g in 100 mL
Code: V06SV4M95S
Classification: ACTIB
OCTOCRYLENEActive
Quantity: 7 g in 100 mL
Code: 5A68WGF6WM
Classification: ACTIB
AVOBENZONEActive
Quantity: 3 g in 100 mL
Code: G63QQF2NOX
Classification: ACTIB
POLYMETHYLSILSESQUIOXANE (11 MICRONS)Inactive
Code: Z570VEV8XK
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/19/2025

carton

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/19/2025

Helps prevent sunburn. If used as directed with other sun protection measures (seeDirections), decreases the risk of skin cancer and early skin aging caused by the sun.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/19/2025

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 7%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/19/2025

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 9/19/2025

For external use only.

Do not useon damaged or broken skin.

When using this productavoid contact with eyes. Rinse with water to remove.

Stop use and ask a doctor ifrash or irritation develops and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/19/2025

If product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/19/2025

For sunscreen use: shake well before use, apply liberally 15 minutes before sun exposure and as needed, reapply: after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours.

**Sun Protection Measures.**Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am - 2 pm, wear long-sleeved shirts, pants, hats, and sunglasses.

Children under 6 months of age: ask a doctor.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/19/2025

Alcohol denat., benzyl alcohol, C12-15 alkyl benzoate, caprylic/capric triglyceride, cassia alata leaf extract, cetearyl alcohol, dicaprylyl carbonate, dicaprylyl ether, diethylhexyl syringylidenemalonate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl behenate, glyceryl stearate citrate, hectorite, isostearyl alcohol, lauryl PEG/PPG-18/18 methicone, octyldodecanol, octyldodecyl xyloside, p=anisic acid, PEG-30 dipolyhydroxystearate, PEG-8 laurate, poly C10-30 alkyl acrylate, polymethylsilsesquioxane, proplyelene carbonate, silica, sodium chloride, sodium dodecylbenezenesulfonate, strene/acrylates copolymer, tocopherol, water, xanthan gum.

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CVS SPF 60 Face Sunscreen - FDA Drug Approval Details