MOISTURE SUNSCREEN SPF 50- titanium dioxide, zinc oxide lotion

Moisture Sunscreen SPF 50 by

Drug Labeling and Warnings

Moisture Sunscreen 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

Zinc Oxide 9.5%

Octinoxate 7.5%

Purpose

Sunscreen

Warnings

Warnings When using this product

• keep out of the eye area
• rinse with water to remove
• stop use and ask a doctor if rash or irritation develops
• for external use onlyl
• keep out of reach of children

Directions

Directions: Apply generously and evenly thirty 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.

Inactive Ingredients

Aqua, Cocos Nucifera (Coconut) Oil, Carthamus Tinctorius (Safflower) Seed Oil, Heptyl Undecylenate, Caprylic/Capric Triglyceride, Cetyl Alcohol, Glycerin, Polyglyceryl-6 Distearate, Glyceryl Stearate, Titanium Dioxide, PEG-100 Stearate, Jojoba Esters, Polyhydroxystearic Acid, Polyglyceryl-3 Beeswax, Disodium EDTA, *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, Ascorbic Acid (Vitamin C),

Principal Display Panel

INGREDIENTS AND APPEARANCE

MOISTURE SUNSCREEN SPF 50 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68062-9001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	12.6 mg  in 120 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	9 mg  in 120 mL

Inactive Ingredients
Ingredient Name	Strength
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)
SAFFLOWER OIL (UNII: 65UEH262IS)
GLYCERIN (UNII: PDC6A3C0OX)
COCONUT OIL (UNII: Q9L0O73W7L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68062-9001-1	120 mL in 1 TUBE; Type 0: Not a Combination Product	09/09/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/09/2021

Labeler - Spa de Soleil (874682867)

Establishment
Name	Address	ID/FEI	Business Operations
Spa de Soleil		874682867	manufacture(68062-9001)