RIVERSOL LIGHTWEIGHT BROAD SPECTRUM SUNSCREEN SPF 30- titanium dioxide, zinc oxide cream 
Riversol Skincare Solutions Inc

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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Riversol Lightweight Broad Spectrum Sunscreen Spf 30

Active Ingredients

Zinc Oxide 10%

Titanium Oxide 6%

Uses

Helps Prevent Sunburn

If used as directed with other sun protection measures ( see Directions) decreases the risk of skin cancer and early skin aging caused by sun.

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop using and ask a doctor is rash occurs

Keep out of reach of children. If product is swallowed get medical help or contact a Poison Control Centre right away.

Directions

Apply liberally 15 minutes before sun exposure.

Reapply at least every 2 hours.

Use a water resistant sunscreen if swimming or sweating

Childre under 6 months: Ask a doctor

Sun Protection Measures. Spending time in the sun increases you risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am - 2 pm Wear long sleeve shirts, pants, hats and sunglasses.

Other Information

Protect this product from excessive heat and direct sun.

Questions or comments?

Call toll free 1-866-774-8377 or visit www.riversol.com

Principal Display Panel

Riversol

Dermatologist Developed fo Sensitive Skin

Lightweight Broad Spectrum Sunscreen

Mineral sun filters (Zn + Ti)

Fragrance Free

SPF 30

Sheer Tint

60 mL / 2 oz

Image of box showing principal display panel

RIVERSOL LIGHTWEIGHT BROAD SPECTRUM SUNSCREEN SPF 30 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72019-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE100 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.09883 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
VITIS VINIFERA SEED (UNII: C34U15ICXA)  
GLYCERIN (UNII: PDC6A3C0OX)  
ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
LAURIC ACID (UNII: 1160N9NU9U)  
STARCH, TAPIOCA (UNII: 24SC3U704I)  
ALCOHOL (UNII: 3K9958V90M)  
AMINOPROPYL ASCORBYL PHOSPHATE (UNII: 290O2PQ83R)  
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATE (UNII: 408UEF2TE8)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SORBIC ACID (UNII: X045WJ989B)  
CAPRYLIC/CAPRIC ACID (UNII: DI775RT244)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)  
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
.BETA.-THUJAPLICIN (UNII: U5335D6EBI)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72019-0001-11 in 1 BOX01/25/2018
160 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/25/2018
Labeler - Riversol Skincare Solutions Inc (203514773)
Establishment
NameAddressID/FEIBusiness Operations
Natures Formulae Health Products Ltd.241385587manufacture(72019-0001)

Revised: 1/2020
Document Id: 9c9c0743-5a6a-33c1-e053-2a95a90af4c2
Set id: 61d06b61-5299-2627-e053-2991aa0a70ed
Version: 2
Effective Time: 20200120
 
Riversol Skincare Solutions Inc