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

Active Ingredients

Titanium Dioxide 4.8%

Zinc Oxide 6.8%

Purpose

Sunscreen

Warnings

Warnings

Directions

Directions

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

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

Tru Skin Rituals_SPF

TRU SKIN RITUALS SPF 25 
titanium dioxide, zinc oxide spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68062-8801
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE8.16 mg  in 170 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE11.56 mg  in 170 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68062-8801-1170 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/17/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02003/17/2023
Labeler - Spa de Soleil (874682867)
Establishment
NameAddressID/FEIBusiness Operations
Spa de Soleil874682867manufacture(68062-8801)

Revised: 3/2023
Document Id: f725cd5c-999f-2393-e053-6394a90a09dc
Set id: f725cd5c-999e-2393-e053-6394a90a09dc
Version: 1
Effective Time: 20230318
 
Spa de Soleil