SUNBURN SOOTHING- glycerin, dimethicone cream

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

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Active ingredient:
Glycerin 6%, Dimethicone 0.5%
Available from:
Supadelixir Co Ltd
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Skin protectant Soothe and protect sunburn and sun damaged skins
Authorization status:
OTC monograph final
Authorization number:
71200-805-10

SUNBURN SOOTHING- glycerin, dimethicone cream

Supadelixir 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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Sunburn Soothing

Drug Facts

Active Ingredients

Glycerin 6%, Dimethicone 0.5%

Purpose

Skin protectant

USE

Soothe and protect sunburn and sun damaged skins

Warnings

For external use only

When using this product do not use on damaged or broken skin

keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if rash occurs

Keep out of reach of children if product is swallowed, get medical help or contact a Poison Control

Center right away.

Directions

Apply sunburn or sun damaged skin after cleansing Sunscreen and toning

Smooth evenly over face & throat

Reapply at least every 2 hours

Children under 6 months of age: Ask a doctor

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Squalane, Butylene Glycol, Hydrogenated Polydecene,

Macadamia Ternifolia Seed Oil, 1,2- Hexanediol, Cetearyl Alcohol, Glyceryl Stearate SE, C14-22

Alcohols, Aloe Barbadensis Leaf Extract, Portulaca Oleracea Extract, Jojoba Esters, Persea Gratissima

(Avocado) Oil, C12-20 Alkyl Glucoside, Cetearyl Olivate, Behenyl Alcohol, Stearic Acid,

Tromethamine, Sorbitan Olivate, Hydrogenated Lecithin, Carbomer, Xanthan Gum, Cholesterol,

Tocopheryl Acetate, Ceramide NP, Phytosphingosine, Palmitoyl sh-Tripeptide-4 Amide

Distributed by

SupadElixir Co., Ltd.

# 410, Building 1, School of Medicine,

1 Kangwondaehak-gil, Chuncheon-si,

Gangwon-do, Korea

www.SE-Tripeptide.com

MADE IN KOREA

After sunburn

Advanced Anti-photoaging Cream

for sun-damaged face & body skin

Packaging

SUNBURN SOOTHING

glycerin, dimethicone cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7120 0 -8 0 5

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

GLYCERIN (UNII: PDC6 A3C0 OX) (GLYCERIN - UNII:PDC6 A3C0 OX)

GLYCERIN

6 0 mg in 1 mL

DIMETHICO NE (UNII: 9 2RU3N3Y1O) (DIMETHICONE - UNII:9 2RU3N3Y1O)

DIMETHICONE

5 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

SQ UALANE (UNII: GW8 9 575KF9 )

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

HYDRO GENATED PO LYDECENE ( 550 MW) (UNII: U333RI6 EB7)

MACADAMIA O IL (UNII: 5156 10 SU8 C)

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

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

GLYCERYL STEARATE SE (UNII: FCZ5MH78 5I)

C14 -2 2 ALCO HO LS (UNII: B1K8 9 38 4RJ)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

PURSLANE (UNII: M6 S8 40 WXG5)

JO JO BA O IL, RANDO MIZED (UNII: 7F0 EV20 QYL)

AVO CADO O IL (UNII: 6 VNO72PFC1)

C12 -2 0 ALKYL GLUCO SIDE (UNII: K6 7N5Z1RUA)

CETEARYL O LIVATE (UNII: 58 B6 9 Q8 4JO)

DO CO SANO L (UNII: 9 G1OE216 XY)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TRO METHAMINE (UNII: 0 23C2WHX2V)

SO RBITAN O LIVATE (UNII: MDL271E3GR)

HYDRO GENATED SO YBEAN LECITHIN (UNII: H110 9 Z9 J4N)

CARBO XYPO LYMETHYLENE (UNII: 0 A5MM30 7FC)

XANTHAN GUM (UNII: TTV12P4NEE)

CHO LESTERO L (UNII: 9 7C5T2UQ7J)

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

CERAMIDE NP (UNII: 4370 DF0 50 B)

PHYTO SPHINGO SINE (UNII: GIN46 U9 Q2Q)

PALMITO YL SH-TRIPEPTIDE-4 AMIDE (UNII: 9 5R2G78 A7J)

Product Characteristics

Color

white

S core

Supadelixir Co Ltd

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7120 0 -8 0 5-10

10 0 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 1/0 2/20 17

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt347

0 1/0 2/20 17

Labeler -

Supadelixir Co Ltd (688481952)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Supadelixir Co Ltd

6 8 8 48 19 52

ma nufa c ture (7120 0 -8 0 5)

Revised: 2/2017

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