Label: RIVERSOL LIGHTWEIGHT BROAD SPECTRUM SUNSCREEN SPF 30- titanium dioxide, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 72019-0001-1 - Packager: Riversol Skincare Solutions Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated January 20, 2020
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- Active Ingredients
- Uses
- Warnings
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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.
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INGREDIENTS AND APPEARANCE
RIVERSOL LIGHTWEIGHT BROAD SPECTRUM SUNSCREEN SPF 30
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72019-0001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 100 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.09883 g in 1 mL Inactive Ingredients Ingredient Name Strength 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 Color brown Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72019-0001-1 1 in 1 BOX 01/25/2018 1 60 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/25/2018 Labeler - Riversol Skincare Solutions Inc (203514773) Establishment Name Address ID/FEI Business Operations Natures Formulae Health Products Ltd. 241385587 manufacture(72019-0001)