SKYLAKE SUNSCREEN- octinoxate, zinc oxide, titanium dioxide cream

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

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Active ingredient:
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37), Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)
Available from:
SKYLAKE
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose: Sunscreen
Authorization status:
OTC monograph not final
Authorization number:
53798-020-01, 53798-020-02

SKYLAKE SUNSCREEN- octinoxate, zinc oxide, titanium dioxide cream

SKYLAKE

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.

----------

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

SKYLAKE SUNSCREEN

octinoxate, zinc oxide, titanium dioxide cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:5379 8 -0 20

Route of Administration

TOPICAL

SKYLAKE

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O ctino xa te (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

O c tino xa te

3.75 g in 50 g

Zinc O xide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8 SF37)

ZINC CATION

3.50 g in 50 g

Tita nium Dio xide (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

Titanium Dio xide

2.70 g in 50 g

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

Butylene g lyco l (UNII: 3XUS8 5K0 RA)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:5379 8 -0 20 -0 2 1 in 1 CARTON

0 3/0 1/20 19

1

NDC:5379 8 -0 20 -0 1 50 g in 1 CONTAINER; Type 0 : No t a Co mbinatio n Pro duct

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 3/0 1/20 19

Labeler -

SKYLAKE (688226324)

Registrant -

SKYLAKE (688226324)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

SkyLake Co ., Ltd.

6 8 8 9 9 50 9 7

ma nufa c ture (5379 8 -0 20 )

Revised: 4/2019

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