PHARMASKINCARE SOLAR-C MOISTURIZER SPF 50- octinoxate, zinc oxide lotion

Pharmaskincare Solar-C Moisturizer SPF 50 by

Drug Labeling and Warnings

Pharmaskincare Solar-C Moisturizer SPF 50 by is a Otc medication manufactured, distributed, or labeled by Spa de Soleil. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octinoxate 7.5%

Zinc Oxide 9.5%

Purpose

Sunscreen

Warnings

• For external use only.
• Do not use on broken or damaged skin
• When using this product, keep out of eyes. Rinse with water to remove.
• Stop use and ask a doctor is rash or irritation occurs or lasts.
• If swallowed, seek medical help or contact a poison control center right away.
• Keep out of reach of children.

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. 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.

PRINCIPAL DISPLAY PANEL

Pharmaskincare SolarC SPF 50.jpg

INGREDIENTS AND APPEARANCE

PHARMASKINCARE SOLAR-C MOISTURIZER SPF 50 
octinoxate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68062-9098
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.238 mg  in 2.5 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.188 mg  in 2.5 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68062-9098-1	120 mL in 1 TUBE; Type 0: Not a Combination Product	10/10/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	10/10/2017

Labeler - Spa de Soleil (874682867)

Establishment
Name	Address	ID/FEI	Business Operations
Spa de Soleil		874682867	manufacture(68062-9098)