FDA.reportPublic FDA data

Moisturizing Day Cream with Sunscreen and Dead Sea Mineral Broad Spectrum SPF 15

Manufacturer
CrystalLine Health & Beauty from the Dead Sea LTD
Effective date
2019-06-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:20:22

Label at a glance#

ProductMoisturizing Day with Sunscreen and Dead Sea Mineral Broad Spectrum SPF 15
Active ingredientOCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONE
Label structure7 sections

Indications and uses

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

Dosage and administration

Apply generously 15 minutes before sun exposure. Re-apply at least every 2 hours Use a water resistance sunscreen if swimming or sweating. 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 sun screen with a broad spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, espec...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethylhexyl Salicylate/Octisalate (5%)

Benzophenone-3/Oxybenzone (4%)

Octocrylene (3%)

Butyl Methoxydibenzolymethane/Avobenzone (1.5%)

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

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

Warnings

WARNINGS SECTION

For external use only

Do not use on 

OTC - DO NOT USE SECTION

  • damaged or broken skin

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water or remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply generously 15 minutes before sun exposure.
  • Re-apply at least every 2 hours
  • Use a water resistance sunscreen if swimming or sweating.
  • 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 sun screen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10AM to 2PM.
  • wear long sleeved shirts, pants, hats and sunglasses.
  • children under 6 months of age 
  • ask a doctor.

Other information

SPL UNCLASSIFIED SECTION

  • Protect the product from excessive heat and direct sun
  • May stain some fabrics

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua, Cetyl Alcohol, Glyceryl Stearate, Glycerin, PEG-40 Stearate, Octyldodecyl Stearoyl Stearate, C12-15 Alkyl Lactate, Caprylic/Capric Triglyceride, Dimethicone, Aloe Barbadensis Leaf Juice, Phenoxyethanol, Sorbitan Tristearate, Fragrance/Parfum, Sodium PCA, Tocopheryl Acetate (Vitamin E), Sodium Benzoate, Sea Salt / Maris Sal (Dead Sea Minerals), Ethylhexylglycerin, Panthenol (Pro Vitamin B5), Hydrolyzed Hyaluronic Acid, Citric Acid

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PakageOuter PakageInner PackageInner Package

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71095-00071095-000-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOXYETHANOLHIE492ZZ3TIACT
SORBITAN TRISTEARATE6LUM696811IACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
WATER059QF0KO0RIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
GLYCERINPDC6A3C0OXIACT
PEG-40 STEARATEECU18C66Q7IACT
OCTYLDODECYL STEAROYL STEARATE3D47Q6D93CIACT
C12-15 ALKYL LACTATEGC844VRD7EIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
DIMETHICONE92RU3N3Y1OIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SODIUM BENZOATEOJ245FE5EUIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PANTHENOLWV9CM0O67ZIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
OCTISALATE4X49Y0596WACTIB
OXYBENZONE95OOS7VE0YACTIB
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB

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
8c3a1e3e-8c2c-5d85-e053-2995a90ac9434a295674-ff8b-2bee-e054-00144ff88e882019-06-26WarningsExact identifier
spl id: 8c3a1e3e-8c2c-5d85-e053-2995a90ac943
spl set id: 4a295674-ff8b-2bee-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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