SKYLAKE SUNSCREEN- octinoxate, zinc oxide, titanium dioxide cream

SKYLAKE SUNSCREEN by

Drug Labeling and Warnings

SKYLAKE SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by SKYLAKE, SkyLake Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Ethylhexyl Methoxycinnamate 7.5%, Zinc Oxide 7%, Titanium Dioxide 5.41%

INACTIVE INGREDIENT

Inactive ingredients:
Water, Cyclomethicone, Butylene Glycol, Caprylic/Capric Triglyceride, Dimethicone Copolyol, CetylPEG/PPG-10/1Dimethicone, Glycerin, Arbutin, Scutellaria Baicalensis Root Extract, Paeonia Suffruticosa Root Extract, Morus Bombycis Leaf Extract, Angelica Gigas Extract, Mentha Piperita(Peppermint) Leaf Extract, Morus Alba Bark Extract, Cnidium Officinale Root Extract, Glycyrrhiza Glabra(Licorice) Root Extract, Hamamelis Virginiana(Witch Hazel) Bark/Leaf Extract, Rosa Centifolia Flower Extract, Cosmos Sulphureus Flower/Leaf/Stem Extract, Jasminum Officinale(Jasmine) Flower Extract, Lilium Candidum Flower Extract, Iris Ensata Extract, Hibiscus Rosa-Sinensis Flower/Leaf Extract , Nelumbo Nucifera Flower Extract, Cetyl Ethylhexanoate, Artemisia Absinthium Extract, Angelica Dahurica Root Extract, Pueraria Lobata Root Extract,Polyethylene, C20-40Acid, Beeswax, Phenyl Trimethicone, Inula Helenium Extract, Laminaria Japonica Extract, Sodium Chloride, Phellodendron Amurense Bark Extract, Eugenia Caryophyllus(Clove) Flower Extract, Disodium EDTA, Adenosine, Dimethicone, Talc, Fragrance

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:

Discontinue use if skin irritation develops. Use only as directed. Store in a cool dark place, avoid high temperatures and exposure to strong sunlight.

DESCRIPTION

Uses:
This natural Sunscreen utilizes only natural preservative and herbal extract such as seven flowers and witch hazel. It shields your skin against harmful UVA/UVB effectively without irritating and drying your skin.

Directions:
Apply liberally on cleansed skin daily, especially on the body parts exposed to the sun. Re-apply after perspiring, swimming or every 4 hours under the sun.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SKYLAKE SUNSCREEN 
octinoxate, zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53798-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	3.75 g  in 50 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	3.50 g  in 50 g
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	2.70 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene glycol (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53798-020-02	1 in 1 CARTON	03/01/2019
1	NDC: 53798-020-01	50 g 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	03/01/2019

Labeler - SKYLAKE (688226324)

Registrant - SKYLAKE (688226324)

Establishment
Name	Address	ID/FEI	Business Operations
SkyLake Co., Ltd.		688995097	manufacture(53798-020)