NATURAL SPF 30- 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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Natural SPF 30

Active Ingredients

Titanium Dioxide 7.2%

Purpose

Sunscreen

Warnings

Warnings When using this product

Keep out of reach of children

Directions: for sunscreen use
● apply generously 15 minutes before sun exposure
● apply to all skin exposed to the sun
● children under 6 months of age: Ask a doctor

Directions: for sunscreen use
● apply generously 15 minutes before sun exposure
● apply to all skin exposed to the sun
● children under 6 months of age: Ask a doctor

Inactive Ingredients

Inactive Ingredients:

isopropyl palmitate, coconut alkanes, coco caprylate/caprate, caprylic/capric triglyceride, stearic acid, alumina, polyhydroxystearic acid, heptyl undecylenate, oryza sativa (rice) bran extract, rosarinus officnailis (rosemary) extract, helianthus annuus (sunflower) seed oil, tocopherol, argania spinosa kernel oil, tocopheryl acetate (vitamin E), bisabolol, squalane

Principal Display Panel

NaturalSPF30

NATURAL SPF 30 
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68062-8304
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE750 mg  in 118 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
JOJOBA OIL (UNII: 724GKU717M)  
SHEA BUTTER (UNII: K49155WL9Y)  
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SQUALANE (UNII: GW89575KF9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68062-8304-1118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/04/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02005/04/2017
Labeler - Spa de Soleil (874682867)
Establishment
NameAddressID/FEIBusiness Operations
Spa de Soleil874682867manufacture(68062-8304)

Revised: 12/2022
Document Id: f0743f09-61e5-4b57-e053-2a95a90ad69a
Set id: 4ebe65c3-c1b9-3496-e054-00144ff88e88
Version: 5
Effective Time: 20221222
 
Spa de Soleil