NATURAL 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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Natural SPF 50

Active Ingredients

Titanium Dioxide 7.2%

Zinc Oxide 9.5%

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:

carthamus tinctorius (safflower) seed oil, coconut alkanes, coco caprylate/caprate, caprylic/capric triglyceride, stearic acid, alumina, polyhydroxystearic acid, helianthus annuus (sunflower) seed oil, pongamia glabra (karanja) seed oil, vitis vinifera (grape) see oil, olea europaea (olive) oil, argania spinosa (argan) oil, oryza sativa (rice) bran extract, rosarinus officnailis (rosemary) extract, tocopherol, argania spinosa kernel oil, tocopheryl acetate (vitamin E), bisabolol, squalane

Principal Display Panel

NaturalSPF50

NATURAL SPF 50 
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68062-8307
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE780 mg  in 118 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE900 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:68062-8307-1118 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(68062-8307)

Revised: 12/2022
Document Id: f07445b1-3601-7a8f-e053-2a95a90ac621
Set id: 4eb87d1e-601a-1209-e054-00144ff8d46c
Version: 5
Effective Time: 20221222
 
Spa de Soleil