SIORISYOU ARE MY SHINING SUNSCREEN by Zenkosmetikos Co., Ltd. / Elan Cosmetic Co.,ltd

SIORISYOU ARE MY SHINING SUNSCREEN by

Drug Labeling and Warnings

SIORISYOU ARE MY SHINING SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Zenkosmetikos Co., Ltd., Elan Cosmetic Co.,ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SIORISYOU ARE MY SHINING SUNSCREEN- zinc oxide, titanium dioxide cream 
Zenkosmetikos Co., Ltd.

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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ACTIVE INGREDIENT

Active ingredients: ZINC OXIDE 16.15%, TITANIUM DIOXIDE 5.10%

INACTIVE INGREDIENT

Inactive ingredients:

Prunus Mume Fruit Water, Dicaprylyl Cabonate, Isoamyl Laurate, Caprylic/Capric Triglyceride, Polyglyceryl-3 Ricinoleate, Bees- wax, Silica, Persea Gratissima (Avocado) Oil, Glycerin, Sorbitan Isostearate, Water, Sodium Chloride, Artemisia Montana Leaf Extract, Ginkgo Biloba Leaf Extract, Centella Asiatica Extract, Vaccinium Corymbosum (Blueberry) Fruit, Rosa Canina Fruit Oil, Scutellaria Baicalensis Root Extract, Paeonia Suffruticosa Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Sodium PCA, (-)-alpha-bisabolol, Tocopherol, Butylene Glycol, Stearic Acid, Aluminum Hydroxide, Citric Acid, Pelargonium Graveolens Flower Oil. Citrus Aurantium Dulcis (Orange) Peel Oil, Amyris Balsamifera Bark Oil, Helianthus Annuus (Sunflower) Seed Oil

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:

(1) Immediately stop using in case of skin abnormalities after use.
(2) Always recap after use.
(3) Use as quickly as possible after opening.

DESCRIPTION

Uses:
■ It can protect your skin from ultraviolet rays.

Directions:
■ As the last step to your skincare regime, take an appropriate amount on the face and gently press the face with your palms for better absorption.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SIORISYOU ARE MY SHINING SUNSCREEN 
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73495-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	4.84 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.53 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
PRUNUS MUME FRUIT OIL (UNII: I4HW888TQ6)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73495-010-02	1 in 1 CARTON	11/01/2019	12/20/2019
1	NDC: 73495-010-01	30 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	12/20/2019

Labeler - Zenkosmetikos Co., Ltd. (694793999)

Registrant - Zenkosmetikos Co., Ltd. (694793999)

Establishment
Name	Address	ID/FEI	Business Operations
Elan Cosmetic Co.,ltd		688204926	manufacture(73495-010)

Revised: 12/2019

Document Id: 2bb24d02-15d6-48f7-844f-0e3fba2ed813

34390-5

Set id: b967ba0f-e2fd-409c-bae7-6d4e1881f7d8

Version: 2

Effective Time: 20191224