DERMA J SUN- homosalate, octisalate, avobenzone, octocrylene cream

Derma J Sun by

Drug Labeling and Warnings

Derma J Sun by is a Otc medication manufactured, distributed, or labeled by Raniq. Co., Ltd, EYESOME. Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Homosalate 9.0%, Ethylhexyl Salicylate 4.0%, Butyl Methoxydibenzoylmethane 3.0%, Octocrylene 2.5%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Propanediol, Alcohol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Pentylene Glycol, Coco-Caprylate/Caprate, Ethylhexyl Triazone, Silica, Cetyl Dimethicone, Dimethicone, Methyl Methacrylate Crosspolymer, Sodium Polyacrylate, Pullulan, Triethanolamine, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylyl Glycol, Tocopheryl Acetate, Allantoin, Laureth-7, Ethylhexylglycerin, Disodium EDTA, Trideceth-6, Glycerin, Butylene Glycol, Human Adipose Stromal Cell Conditioned Media, Collagen, Lactobacillus Ferment Lysate, 1,2-Hexanediol, Hexapeptide-9, Palmitoyl Tetrapeptide-7, Palmitoyl Hexapeptide-12, Tripeptide-3, Tripeptide-1, Acetyl Hexapeptide-8, Fragrance

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:

For external uses only.
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash or irritation develops and lasts.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away

DESCRIPTION

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

Directions:
■ Apply generously 15 minutes before sun exposure
■ Re-apply: After 80 minutes of swimming or sweating / Immediately after towel drying / at least every 2hours
■ Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including : limit time in the sun, especially from 10 am – 2 pm / wear long-sleeved shirts, pants, hats and sunglasses
■ Children under 6 months : Ask a doctor before uses

QUESTIONS

Questions
www.dermaj.kr

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMA J SUN 
homosalate, octisalate, avobenzone, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73225-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	4.5 g  in 50 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	2.0 g  in 50 mL
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	Avobenzone	1.5 g  in 50 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	1.25 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Propanediol (UNII: 5965N8W85T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73225-020-02	1 in 1 CARTON	11/01/2019
1	NDC: 73225-020-01	50 mL in 1 CONTAINER; 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	11/01/2019

Labeler - Raniq. Co., Ltd (695014611)

Registrant - Raniq. Co., Ltd (695014611)

Establishment
Name	Address	ID/FEI	Business Operations
EYESOME. Co.,Ltd.		557795360	manufacture(73225-020)