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

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

Drug Labeling and Warnings

Moisturizing Day with Sunscreen and Dead Sea Mineral Broad Spectrum SPF 15 by is a Otc medication manufactured, distributed, or labeled by CrystalLine Health & Beauty from the Dead Sea LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MOISTURIZING DAY WITH SUNSCREEN AND DEAD SEA MINERAL BROAD SPECTRUM SPF 15- octisalate, oxybenzone, octocrylene, avobenzone cream 
CrystalLine Health & Beauty from the Dead Sea LTD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

Drug facts

Active ingredients

Ethylhexyl Salicylate/Octisalate (5%)

Benzophenone-3/Oxybenzone (4%)

Octocrylene (3%)

Butyl Methoxydibenzolymethane/Avobenzone (1.5%)

Purpose

Sunscreen

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

Warnings

For external use only

Do not use on 

  • damaged or broken skin

When using this product

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

Stop use and ask a doctor

  • if rash occurs

Keep out of reach of children.

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

Directions

  • 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

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

Inactive ingredients

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:

Outer PakageInner Package

MOISTURIZING DAY WITH SUNSCREEN AND DEAD SEA MINERAL BROAD SPECTRUM SPF 15 
octisalate, oxybenzone, octocrylene, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71095-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE30 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SORBITAN TRISTEARATE (UNII: 6LUM696811)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
WATER (UNII: 059QF0KO0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)  
C12-15 ALKYL LACTATE (UNII: GC844VRD7E)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PANTHENOL (UNII: WV9CM0O67Z)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71095-000-001 in 1 BOX03/07/201706/30/2019
150 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/07/201706/30/2019
Labeler - CrystalLine Health & Beauty from the Dead Sea LTD (600582704)
Establishment
NameAddressID/FEIBusiness Operations
CrystalLine Health & Beauty from the Dead Sea LTD600582704manufacture(71095-000)

Revised: 6/2019
Document Id: 8c3a1e3e-8c2c-5d85-e053-2995a90ac943
Set id: 4a295674-ff8b-2bee-e054-00144ff88e88
Version: 2
Effective Time: 20190626
 
CrystalLine Health & Beauty from the Dead Sea LTD