RAIN OR SHINE- octinoxate homosalate octisalate titanium dioxide cream 
Jaxon Lane, 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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RAIN OR SHINE

Active ingredients

Octinoxate, Homosalate, Octisalate, titanium dioxide

Purpose: Sunscreen

Inactive Ingredients

Water, Pentylene Glycol, Methylpropanediol, Caprylyl Methicone, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Isononyl Isononanoate, Ethylhexyl Triazone, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, Cyclopentasiloxane, Phenoxyethanol, Sodium Acrylate/Sodium   Acryloyldimethyl Taurate Copolymer, Isohexadecane, Aluminium Hydroxide, Stearic Acid, Dimethicone/Vinyl Dimethicone Crosspolymer, Tocopheryl Acetate (Vitamin E), Sorbitan Isostearate, Ammoniumacryloyldimethyl Taurate/VP Copolymer, Allantoin, Polysorbate 80, Butylene Glycol, Sorbitan Oleate, BHT Xanthan Gum, Biosaccharide Gum-4, Sodium Hyaluronate, Moringa Seed Oil, Ethylhexylglycerin, Green Tea Extract, Licorice Root Extract, Panax Ginseng Root Extract, Fragrance

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 the 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 use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Apply liberally 15 minutes before sun exposure. Reapply every 2 hours and after swimming. Children under 6 months: Ask a doctor.

Sun Protection Measures: Sun exposure increases your risc of skin cancer and early skin aging. Use a sunscreen with a minium Broad Spectrum SPF15+ Limit time in the Sun, especially from 10 am - 2pm, wear hats, sunglasses, long-sleeve, clothing and pants. 

Other Information:

Protect this product from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL

RAIN OR SHINE-1

AIN OR SHINE-2

RAIN OR SHINE 
octinoxate homosalate octisalate titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73072-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE3 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
BEMOTRIZINOL (UNII: PWZ1720CBH)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4)  
LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EX0F4CZ66H)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
ALLANTOIN (UNII: 344S277G0Z)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
XANTHAN GUM (UNII: TTV12P4NEE)  
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73072-002-0160 mL in 1 TUBE; Type 0: Not a Combination Product07/25/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/25/2019
Labeler - Jaxon Lane, Inc. (114672469)
Registrant - Jaxon Lane, Inc. (114672469)
Establishment
NameAddressID/FEIBusiness Operations
EYESOME. Co.,Ltd.557795360manufacture(73072-002)

Revised: 10/2020
Document Id: 36b7cd53-6424-4069-a956-c3d915282260
Set id: de54a11d-bb6b-4150-a408-1f6f1ea1ef69
Version: 2
Effective Time: 20201019
 
Jaxon Lane, Inc.