OS SILKY SUN CUSHION BROAD SPECTRUM SPF 50- ensulizole, octinoxate, octocrylene, titanium dioxide, zinc oxide lotion

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

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Active ingredient:
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM), ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)
Available from:
Dong Sung Bio Pharm. Co., Ltd.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Helps to 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:
42361-158-01

OS SILKY SUN CUSHION BROAD SPECTRUM SPF 50- ensulizole, octinoxate, octocrylene,

titanium dioxide, zinc oxide lotion

Dong Sung Bio Pharm. 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.

----------

42361-158 Drug Facts

Drug Facts

Ethylhexyl Methoxycinnamate 7.4%

Octocrylene 3.0%

Phenylbenzimidazole Sulfonic Acid 3.9%

Titanium Dioxide 4.9%

Zinc Oxide 4.9%

Drug Facts

Sunscreen

Uses

Helps to 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. Discontinue use if signs of irritation or

rash appear. Avoid contact with eyes. Wash off immediately with cold water if product comes in contact

with eyes. Keep this and all drugs out of reach of children. In case of accidental ingestion, seek

professional assistance or contact a Poison Control Center right away.

Warnings

Keep this and all drugs out of reach of children. In case of accidental ingestion, seek professional

assistance or contact a Poison Control Center right away.

Directions

Apply liberally on face 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or

sweating. Reapply at least every 2 hours. 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 a.m. - 2 p.m. and wear long-sleeved shirts, pants, hats and sunglasses. Children

under 6 months: Ask a doctor.

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water, Cyclopentasiloxane, Cyclohexasiloxane, Butylene Glycol, PEG-10 Dimethicone, Methyl

Methacrylate Crosspolymer, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Quaternium-

18 Bentonite, Sodium Hydroxide, Aluminum Hydroxide, Stearic Acid, Fragrance, Chlorphenesin,

Triethoxycaprylylsilane, Disodium EDTA, Iron Oxide (CI 77491, CI 77492), Tocopheryl Acetate,

Hydrolyzed Silk, Royal Jelly Extract, Dimethicone, 1,2-Hexanediol, Sodium Hyaluronate,

Phenoxyethanol, Ethylhexylglycerin

OS Silky Sun Cushion

Broad Spectrum SPF 50+

OS SILKY SUN CUSHION BROAD SPECTRUM SPF 50

ensulizole, octinoxate, octocrylene, titanium dioxide, zinc oxide lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:4236 1-158

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

1.0 36 g in 14 g

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

TITANIUM DIOXIDE

0 .6 9 7 g in 14 g

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

ZINC CATION

0 .6 8 6 g in 14 g

O CTO CRYLENE (UNII: 5A6 8 WGF6 WM) (OCTOCRYLENE - UNII:5A6 8 WGF6 WM)

OCTOCRYLENE

0 .42 g in 14 g

ENSULIZO LE (UNII: 9 YQ9 DI1W42) (ENSULIZOLE - UNII:9 YQ9 DI1W42)

ENSULIZOLE

0 .546 g in 14 g

Inactive Ingredients

Ingredient Name

Stre ng th

METHYL METHACRYLATE/GLYCO L DIMETHACRYLATE CRO SSPO LYMER (UNII: EG9 79 8 8 M5Q)

CYCLO METHICO NE 5 (UNII: 0 THT5PCI0 R)

WATER (UNII: 0 59 QF0 KO0 R)

CYCLO METHICO NE 6 (UNII: XHK3U310 BA)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

1,2 -HEXANEDIO L (UNII: TR0 46 Y3K1G)

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

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

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

ALUMINUM HYDRO XIDE (UNII: 5QB0 T2IUN0 )

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

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

STEARIC ACID (UNII: 4ELV7Z6 5AP)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

HYALURO NATE SO DIUM (UNII: YSE9 PPT4TH)

PEG-10 DIMETHICO NE ( 6 0 0 CST) (UNII: 8 PR7V1SVM0 )

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

BENTO Q UATAM (UNII: 7F46 5U79 Q1)

TRIETHO XYCAPRYLYLSILANE (UNII: LDC331P0 8 E)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

RO YAL JELLY (UNII: L49 7I37F0 C)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:4236 1-158 -0 1

1 in 1 CARTON

0 5/25/20 19

1

14 g in 1 CASE; Type 0 : No t a Co mbinatio n Pro duct

Dong Sung Bio Pharm. Co., Ltd.

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 5/25/20 19

Labeler -

Dong Sung Bio Pharm. Co., Ltd. (687811661)

Registrant -

Dong Sung World Wide USA, Inc. (784969219)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Do ng Sung Bio Pharm. Co ., Ltd.

6 8 78 116 6 1

la be l(4236 1-158 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Omar Sharif Co smetic Co ., Ltd.

6 8 9 316 318

ma nufa c ture (4236 1-158 )

Revised: 10/2019

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