FDA.reportPublic FDA data

KEYS SOULCARE DAILY MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREEN

Manufacturer
e.l.f. Cosmetics, Inc
Effective date
2024-12-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:40:50

Label at a glance#

ProductKEYS SOULCARE DAILY MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREEN
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure10 sections

Dosage and administration

Apply libreally 15 minutes before sun exposure, Reapply at least every 2 hours. Use water resistant sunscreen if swimming or sweating. 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 Braod Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in sun, especially from 10 a.m.-2 p.m., wear lo...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%

Homosalate 9.0%

Octisalate 5.0%

Octocrylene 7.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

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

Warning

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product:

OTC - WHEN USING SECTION

keep out of eyes, Rinse with water to remove.

Stop use and ask a doctorif:

OTC - STOP USE SECTION

rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or conact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply libreally 15 minutes before sun exposure, Reapply at least every 2 hours.
  • Use water resistant sunscreen if swimming or sweating.
  • 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 Braod Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in sun, especially from 10 a.m.-2 p.m., wear long-sleeved shirts, pants, hats and sunglasses. Children under 6 months of age: ask a doctor. Sun Protection Measures:

Other Information

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Glycerin, Polyglyceryl-3 Distearate, Niacinamide, Aluminum Starch Octenylsuccinate, Trehalose, Silica, Stearyl Heptanoate, Phenoxyethanol, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Chamomilla Recutita (Matricaria) Flower Water, Panthenol, Squalane, Butylene Glycol, Stearic Acid, Palmitic Acid, Cetearyl Olivate, Sorbitan Olivate, Cetearyl Alcohol, Glyceryl Stearate Citrate, Stearyl Caprylate, Dimethicone, Polyacrylate Crosspolymer-6, Acrylates/Polytrimethylsiloxymethacrylate Copolymer, Coco-Glucoside, Carbomer, Caprylyl Glycol, Ethylhexylglycerin, Disodium EDTA

Questions or comments?

OTC - QUESTIONS SECTION

1-888-315-9814

Package Labeling:50 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling:15 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Package Labeling:5 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76354-442-01KEYS SOULCARE DAILY MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREEN1 in 1 CARTONCREAM14
76354-442-01KEYS SOULCARE DAILY MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREEN50 mL in 1 BOTTLECREAM504
76354-442-02KEYS SOULCARE DAILY MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREEN15 mL in 1 BOTTLECREAM154
76354-442-02KEYS SOULCARE DAILY MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREEN1 in 1 CARTONCREAM14
76354-442-03KEYS SOULCARE DAILY MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREEN5 mL in 1 BOTTLECREAM54
76354-442-03KEYS SOULCARE DAILY MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREEN1 in 1 CARTONCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76354-442KEYS SOULCARE DAILY MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) CREAM [E.L.F. COSMETICS, INC]4Current NDC, Legacy NDC, 6 package rows20241208_2ba71f81-54d0-4955-9bae-2b6e35c9c35f.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76354-44276354-442-01, 76354-442-02, 76354-442-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
POLYGLYCERYL-3 DISTEARATEZI1LK470XVIACT
NIACINAMIDE25X51I8RD4IACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
TREHALOSEB8WCK70T7IIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARYL HEPTANOATE2M4UGL1NCNIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PALMITOYL TRIPEPTIDE-1RV743D216MIACT
PALMITOYL TETRAPEPTIDE-7Q41S464P1RIACT
CHAMOMILE FLOWER OIL60F80Z61A9IACT
PANTHENOLWV9CM0O67ZIACT
SQUALANEGW89575KF9IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
STEARIC ACID4ELV7Z65APIACT
PALMITIC ACID2V16EO95H1IACT
CETEARYL OLIVATE58B69Q84JOIACT
SORBITAN OLIVATEMDL271E3GRIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERYL STEARATE CITRATEWH8T92A065IACT
STEARYL CAPRYLATE06TS6O9194IACT
DIMETHICONE92RU3N3Y1OIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
COCO GLUCOSIDEICS790225BIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KEYS SOULCARE DAILY MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc2ba71f81-54d0-4955-9bae-2b6e35c9c35f2024-12-05WarningsExact identifier
ndc (package): 76354-442-02
ndc (package): 76354-442-03
ndc (package): 76354-442-01
ndc (product): 76354-442
ndc11 (package): 76354044203
ndc11 (package): 76354044202
ndc11 (package): 76354044201
spl id: 288926ba-4d1e-1546-e063-6394a90a557f
spl set id: 2ba71f81-54d0-4955-9bae-2b6e35c9c35f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.