RAIN OR SHINE- octinoxate homosalate octisalate titanium dioxide cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Octinoxate, Homosalate, Octisalate, titanium dioxide
Available from:
Jaxon Lane, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose : Sunscreen 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.
Authorization status:
OTC monograph not final
Authorization number:
73072-002-01

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.

----------

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

Us es :

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

octinoxate homosalate octisalate titanium dioxide cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:730 72-0 0 2

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

7 g in 10 0 mL

HO MO SALATE (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S)

HOMOSALATE

3 g in 10 0 mL

O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

OCTISALATE

3 g in 10 0 mL

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

1.5 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

PENTYLENE GLYCO L (UNII: 50 C130 7PZG)

METHYLPRO PANEDIO L (UNII: N8 F53B3R4R)

CAPRYLYL TRISILO XANE (UNII: Q9 5M2P1KJL)

BEMO TRIZINO L (UNII: PWZ1720 CBH)

ISO NO NYL ISO NO NANO ATE (UNII: S4V5BS6 GCX)

ETHYLHEXYL TRIAZO NE (UNII: XQN8 R9 SAK4)

LAURYL METHACRYLATE/GLYCO L DIMETHACRYLATE CRO SSPO LYMER (UNII: EX0 F4CZ6 6 H)

CYCLO METHICO NE 5 (UNII: 0 THT5PCI0 R)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

SO DIUM ACRYLATE/SO DIUM ACRYLO YLDIMETHYLTAURATE CO PO LYMER ( 4 0 0 0 0 0 0 MW) (UNII:

1DXE3F3OZX)

ISO HEXADECANE (UNII: 9 18 X1OUF1E)

ALUMINUM HYDRO XIDE (UNII: 5QB0 T2IUN0 )

STEARIC ACID (UNII: 4ELV7Z6 5AP)

DIMETHICO NE/VINYL DIMETHICO NE CRO SSPO LYMER ( SO FT PARTICLE) (UNII: 9 E4CO0 W6 C5)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

SO RBITAN ISO STEARATE (UNII: 0 1S2G2C1E4)

AMMO NIUM ACRYLO YLDIMETHYLTAURATE/VP CO PO LYMER (UNII: W59 H9 29 6 ZG)

ALLANTO IN (UNII: 344S277G0 Z)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

SO RBITAN MO NO O LEATE (UNII: 0 6 XEA2VD56 )

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

XANTHAN GUM (UNII: TTV12P4NEE)

BIO SACCHARIDE GUM-4 (UNII: 9 XRL0 57X9 0 )

HYALURO NATE SO DIUM (UNII: YSE9 PPT4TH)

MO RINGA O LEIFERA SEED O IL (UNII: REM6 A5QMC0 )

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

GLYCYRRHIZA GLABRA (UNII: 278 8 Z9 758 H)

ASIAN GINSENG (UNII: CUQ3A77YXI)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:730 72-0 0 2-0 1

6 0 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 7/25/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 7/25/20 19

Labeler -

Jaxon Lane, Inc. (114672469)

Jaxon Lane, Inc.

Registrant -

Jaxon Lane, Inc. (114672469)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

EYESOME. Co .,Ltd.

55779 536 0

ma nufa c ture (730 72-0 0 2)

Revised: 10/2020

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