RAIN OR SHINE- octinoxate homosalate octisalate titanium dioxide cream

RAIN OR SHINE by

Drug Labeling and Warnings

RAIN OR SHINE by is a Otc medication manufactured, distributed, or labeled by Jaxon Lane, Inc., EYESOME. Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Octinoxate, Homosalate, Octisalate, titanium dioxide

PURPOSE

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. 

KEEP OUT OF REACH OF CHILDREN

Other Information:

Protect this product from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RAIN OR SHINE 
octinoxate homosalate octisalate titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73072-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	3 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73072-002-01	60 mL in 1 TUBE; Type 0: Not a Combination Product	07/25/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/25/2019

Labeler - Jaxon Lane, Inc. (114672469)

Registrant - Jaxon Lane, Inc. (114672469)

Establishment
Name	Address	ID/FEI	Business Operations
EYESOME. Co.,Ltd.		557795360	manufacture(73072-002)