Moisture Sunscreen SPF 50: Package Insert and Label Information

MOISTURE SUNSCREEN SPF 50- zinc oxide and octinoxate 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.

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

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 12.6 mg in 120 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE 9 mg in 120 mL
Inactive Ingredients
Ingredient Name Strength
HEPTYL UNDECYLENATE
SAFFLOWER OIL
GLYCERIN
COCONUT OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68062-9001-1 120 mL in 1 TUBE None
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 Operations
Spa de Soleil 874682867 manufacture (68062-9001)

Revised: 09/2021 Spa de Soleil

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