MOISTURE SUNSCREEN SPF 50- titanium dioxide, zinc oxide 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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Moisturizer Sunscreen SPF 50

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

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

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

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

Labeler - Spa de Soleil (874682867)

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