INCELLDERM COCKTAIL AQUA SUN- octinoxate, octisalate, homosalate, titanium dioxide gel

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

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Active ingredient:
Ethylhexyl Methoxycinnamate 7.00% Ethylhexyl Salicylate 3.00% Homosalate 3.00% Titanium Dioxide 1.49%
Available from:
Riman Co., Ltd.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sunscreen
Authorization status:
OTC monograph not final
Authorization number:
72650-060-01, 72650-060-02

INCELLDERM COCKTAIL AQUA SUN- octinoxate, octisalate, homosalate, titanium

dioxide gel

Riman 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.

----------

ACTIVE INGREDIENTS

Ethylhexyl Methoxycinnamate 7.00%

Ethylhexyl Salicylate 3.00%

Homosalate 3.00%

Titanium Dioxide 1.49%

INACTIVE INGREDIENTS

Aloe Barbadensis Leaf Juice, Butylene Glycol, Ethyl Hexanediol, 1,2- Hexanediol, Niacinamide,

Pentylene Glycol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Aluminum Hydroxide, Stearic

Acid, Caprylyl Methicone, Glycerin, Ethylhexy Triazone, Isononyl Isononanoate, Sodium

Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Sorbitan

Oleate, Water, Water, Sodium Hyaluronate, 1,2- Hexanediol, 1,2-Hexanediol, Cyclopentasiloxane,

Dimethicone/Vinyl Dimethicone Crosspolymer, Lauryl Methacrylate/Glycol Dimethacrylate

Crosspolymer, Ammonium Acryloyldimethyltaurate/VP Copolymer, Allantoin, Tocopheryl Acetate,

Citrus Aurantium Dulcis (Orange) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Pelargonium

Graveolens Flower Oil, Amyris Balsamifera Bark Oil, Citrus Grandis (Grapefruit) Peel Oil, Eucalyptus

Globulus Leaf Oil, Mentha Arvensis Leaf Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Citrus

Aurantium Bergamia (Bergamot) Fruit Oil, Juniperus Mexicana Oil, Boswellia Carterii Oil, Sorbitan

Isostearate, Ethylhexylglycerin, Adenosine, Xanthan Gum, Glycerin, Water, Pancratium Maritimum

Extract, Water, Butylene Glycol, Sophora Japonica Fruit Extract, Ethyl Hexanediol, 1,2- Hexanediol,

Water, Butylene Glycol, Althaea Rosea Flower Extract, Aloe Barbadensis Leaf Extract,

Phenoxyethanol, Ethylhexylglycerin, Polyglyceryl-3 Methylglucose Distearate

PURPOSE

Sunscreen

WARNINGS

1. Consult a physician if red spots, swollenness, itchiness, or any other abnormal symptoms or side

effects develops on the applied area during or after use or under direct sunlight.

2. Do not use on wound, etc.

3. Precautions for handling and storage

a) Keep out of the reach of children

b) Avoid direct sunlight

DESCRIPTION

Uses:

Protects skin from UV rays (SPF50 + / PA +++)

Directions:

After gently shaking it up and down, apply to the skin or mix with the cocktail BB and apply to the whole

face. Apply this product once every 2 hours.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INCELLDERM COCKTAIL AQUA SUN

octinoxate, octisalate, homosalate, titanium dioxide gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:726 50 -0 6 0

Route of Administration

TOPICAL

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

3.50 g in 50 mL

O ctisa la te (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

O c tisa la te

1.50 g in 50 mL

Ho mo sa la te (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S)

Ho mo sa la te

1.50 g in 50 mL

Riman Co., Ltd.

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

Titanium Dio xide

0 .74 g in 50 mL

Inactive Ingredients

Ingredient Name

Stre ng th

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

Butylene Glyco l (UNII: 3XUS8 5K0 RA)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End Date

1

NDC:726 50 -0 6 0 -

1 in 1 CARTON

0 3/0 1/20 19

1

NDC:726 50 -0 6 0 -

50 mL in 1 CONTAINER; Type 0 : No t a Co mbinatio n

Pro duc t

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 -

Riman Co., Ltd. (694893735)

Registrant -

Riman Co., Ltd. (694893735)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

HANSOLBIOTECH

6 9 445516 5

ma nufa c ture (726 50 -0 6 0 )

Revised: 8/2020

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