TRU SKIN RITUALS SPF 25- titanium dioxide, zinc oxide spray

Tru Skin Rituals SPF 25 by

Drug Labeling and Warnings

Tru Skin Rituals SPF 25 by is a Otc medication manufactured, distributed, or labeled by Spa de Soleil. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Titanium Dioxide 4.8%

Zinc Oxide 6.8%

Purpose

Sunscreen

Warnings

Warnings

• For external use only
• Do not use on damaged or broken skin
• Stop use and ask a doctor if rash occurs
• When using this product, keep out of eyes
• Rinse with water to remove
• Keep out of reach of children
• If swallowed, get medical help or contact a Poison Control Center right away

Directions

Directions

• Apply liberally 15 minutes before sun exposure
• Apply to all skin exposed to the sun
  

Inactive Ingredients

Inactive Ingredients:

Alumina, Argania Spinosa Kernel Oil, Bisabolol, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Coconut Alkanes (And) Coco-Caprylate/Caprate, Helianthus Annuus (Sunflower) Extract, Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated Castor Oil, Oryza Sativa (Rice) Bran Extract, Polyhydroxystearic Acid, Ricinus Communis (Castor) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Sodium Hyaluronate (Hyaluronic Acid), Stearic Acid, Tocopherol, Tocopheryl Acetate (Vitamin E)

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

DIRECTIONS:

Apply liberally 15 minutes before sun exposure

Apply to all skin exposed to the sun

Reapply:

after 40 minutes of swimming or sweating

immediately after towel drying

at least every 2 hours

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TRU SKIN RITUALS SPF 25 
titanium dioxide, zinc oxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68062-8801
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	8.16 mg  in 170 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	11.56 mg  in 170 mL

Inactive Ingredients
Ingredient Name	Strength
SAFFLOWER OIL (UNII: 65UEH262IS)
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
ALUMINUM OXIDE (UNII: LMI26O6933)
COCONUT ALKANES (UNII: 1E5KJY107T)
ARGANIA SPINOSA SEED (UNII: 8H7X7XB54H)
.BETA.-BISABOLOL (UNII: LP618AV2EA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68062-8801-1	170 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/17/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	03/17/2023

Labeler - Spa de Soleil (874682867)

Establishment
Name	Address	ID/FEI	Business Operations
Spa de Soleil		874682867	manufacture(68062-8801)