PHARMASKINCARE SOLAR-C MOISTURIZER SPF 30- titanium dioxide lotion 
Spa de Soleil

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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Pharmaskincare Solar-C Moisturizer SPF 30

Active Ingredient

Titanium Dioxide 10.5%

Purpose

Sunscreen

Warnings

Directions

Apply every morning as a daily moisturizer. Apply generously and evenly 15 minutes before sun exposure. Reapply at least every two hours. Use a water-resistant sunscreen if swimming or sweating. Children under six months of age: consult a doctor before use.

Other Information

Protect the product in this container from excessive heat.

Uses:

Helps prevent sunburn. Higher SPF gives more sunburn protection. Designed for skin highly sensitive to sunburn. If used as directed with other sun protection measures (see Sun Alert) decreases the risk of skin cancer and early skin aging caused by the sun.

Sun Alert: Spending time in the use 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 such as limited time in the sun, especially from 10 a.m. to 2 p.m. Wear long pants, hats, sunglasses, and long-sleeve shirts.

Inactive Ingredients:

Water, Cocos Nucifera (Coconut) Oil, Carthamus Tinctorius (Safflower) Seed Oil, Cetyl Alcohol, Caprylic/Capric Triglyceride, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Titanium Dioxide, Polyglyceryl-3 Beeswax, Polyglyceryl-6 Distearate, Jojoba Esters, Polyhydroxystearic Acid, Carbomer, *CO Glycerin, Sodium Hydroxide, Thymus Vulgaris (Thyme) Leaf Extract, Rosa Canina Fruit Extract, Gardenia Florida Fruit Extract, Fucus Vesiculosus Extract, *CO Carum Petroselinum (Parsley) Extract, *CO Centella Asiatica Leaf Extract, *CO Cucumis Sativus (Cucumber) Seed Extract, *CO Daucus Carota Sativa (Carrot) Root Extract, *CO Euphrasia Officinalis Extract, Benzyl Alcohol, Disodium EDTA, Dehydroacetic Acid

Warning

Keep out of reach of children.

Pharmaskincare SolarC SPF 30

Pharmaskincare SolarC SPF 30

PHARMASKINCARE SOLAR-C MOISTURIZER SPF 30 
titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68062-9099
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.2625 mg  in 2.5 mL
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
WATER (UNII: 059QF0KO0R)  
COCONUT OIL (UNII: Q9L0O73W7L)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68062-9099-1120 mL in 1 TUBE; Type 0: Not a Combination Product10/10/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/10/2017
Labeler - Spa de Soleil (874682867)
Establishment
NameAddressID/FEIBusiness Operations
Spa de Soleil874682867manufacture(68062-9099)

Revised: 12/2018
Document Id: 7e0d3502-14fd-8390-e053-2a91aa0ace24
Set id: 5b3e068e-654c-8532-e053-2a91aa0aab95
Version: 3
Effective Time: 20181227
 
Spa de Soleil