PLUSHMALLOW SUNSTICK- octocrylene, homosalate, ethylhexyl salicylate, butyl methoxydibenzoylmethane stick

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

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Active ingredient:
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM), AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)
Available from:
COSNINE Inc
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
protects the skin from harmful UV rays (SPF50+ PA++++) Evenly apply a moderate amount on areas exposed to sunlight during the last step of your skincare routine. Carry it with you at all times to frequently apply to necessary areas (face, body).
Authorization status:
OTC monograph final
Authorization number:
73330-0001-1

PLUSHMALLOW SUNSTICK- octocrylene, homosalate, ethylhexyl salicylate, butyl

methoxydibenzoylmethane stick

COSNINE Inc

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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Drug Facts

Octocrylene, Homosalate, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane

Dimethicone

Polyethylene

Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer

Ozokerite

Acrylates Copolymer

Silica

Neopentyl Glycol Diheptanoate

Butyloctyl Salicylate

Cetyl Ethylhexanoate

HDI/Trimethylol Hexyllactone Crosspolymer

Polymethyl Methacrylate

Cetyl Alcohol

Tocopheryl Acetate

Caprylic/Capric Triglyceride

Citrus Aurantium Dulcis (Orange) Peel Oil

Geranium Maculatum Oil

Lavandula Angustifolia (Lavender) Oil

Citrus Aurantium Bergamia (Bergamot) Fruit Oil

Cymbopogon Martini Oil

Anthemis Nobilis Flower Oil

protects the skin from harmful UV rays (SPF50+ PA++++)

keep out of reach of the children

Evenly apply a moderate amount

on areas exposed to sunlight during the last step of

your skincare routine. Carry it with you at all times

to frequently apply to necessary areas (face, body).

1. While using this product , if there

is any abnormal symptoms or side effect such as red spot,

swelling or itching, please consult with dermatologist.

2. Do not use in areas with wounds 3. Instructions for sto

-rage and usage. (i) Keep out of reach of infants and chil

-dren (ii) Store it in a place away from direct sunlight

for external use only

PLUSHMALLOW SUNSTICK

octocrylene, homosalate, ethylhexyl salicylate, butyl methoxydibenzoylmethane stick

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:73330 -0 0 0 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

OCTOCRYLENE

9 .5 g in 10 0 g

AVO BENZO NE (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX)

AVOBENZONE

3 g in 10 0 g

HO MO SALATE (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S)

HOMOSALATE

9 .5 g in 10 0 g

O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

OCTISALATE

4.5 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

COSNINE Inc

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:73330 -0 0 0 1-1

19 g in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /31/20 19

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 rt352

0 8 /31/20 19

Labeler -

COSNINE Inc (694607163)

Registrant -

COSNINE Inc (694607163)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

COSNINE Inc

6 9 46 0 716 3

ma nufa c ture (73330 -0 0 0 1)

Revised: 8/2019

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