FDA.reportPublic FDA data

RAIN OR SHINE

Manufacturer
Jaxon Lane, Inc. | EYESOME. Co.,Ltd.
Effective date
2020-10-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:32:02

Label at a glance#

ProductRAIN OR SHINE
Active ingredientOCTINOXATE, HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE
Label structure8 sections

Indications and 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.

Dosage and administration

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. 

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate, Homosalate, Octisalate, titanium dioxide

OTC - PURPOSE SECTION

Purpose: Sunscreen

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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:

INDICATIONS & USAGE SECTION

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:

WARNINGS SECTION

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:

DOSAGE & ADMINISTRATION SECTION

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:

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RAIN OR SHINE-1RAIN OR SHINE-1

AIN OR SHINE-2AIN OR SHINE-2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73072-002-012021-07-23C16284748780-1c7ccaba7-1c95-fd44-e053-dadaa90aa01bRAIN OR SHINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73072-002-01RAIN OR SHINE60 mL in 1 TUBECREAM602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73072-002RAIN OR SHINE (OCTINOXATE HOMOSALATE OCTISALATE TITANIUM DIOXIDE) CREAM [JAXON LANE, INC.]2Legacy NDC, 1 package rows20201020_de54a11d-bb6b-4150-a408-1f6f1ea1ef69.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73072-00273072-002-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
PENTYLENE GLYCOL50C1307PZGIACT
METHYLPROPANEDIOLN8F53B3R4RIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
BEMOTRIZINOLPWZ1720CBHIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
ETHYLHEXYL TRIAZONEXQN8R9SAK4IACT
LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMEREX0F4CZ66HIACT
CYCLOMETHICONE 50THT5PCI0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)1DXE3F3OZXIACT
ISOHEXADECANE918X1OUF1EIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
STEARIC ACID4ELV7Z65APIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
ALLANTOIN344S277G0ZIACT
POLYSORBATE 806OZP39ZG8HIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
XANTHAN GUMTTV12P4NEEIACT
BIOSACCHARIDE GUM-49XRL057X90IACT
HYALURONATE SODIUMYSE9PPT4THIACT
MORINGA OLEIFERA SEED OILREM6A5QMC0IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
ASIAN GINSENGCUQ3A77YXIIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
36b7cd53-6424-4069-a956-c3d915282260de54a11d-bb6b-4150-a408-1f6f1ea1ef692020-10-19WarningsExact identifier
spl id: 36b7cd53-6424-4069-a956-c3d915282260
spl set id: de54a11d-bb6b-4150-a408-1f6f1ea1ef69

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.