MOONFLASH CUSHION

Main information

  • Trade name:
  • MOONFLASH CUSHION- octinoxate, titanium dioxide, zinc oxide, octisalate powder
  • Composition:
  • Octinoxate 0.84 g in 12 g
  • Administration route:
  • TOPICAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MOONFLASH CUSHION- octinoxate, titanium dioxide, zinc oxide, octisalate powder
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Purpose: Sunscreen

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph not final
  • Authorization number:
  • 71786-050-01, 71786-050-02
  • Last update:
  • 21-06-2019

Summary of Product characteristics: dosage, interactions, side effects

MOONFLASH CUSHION- octinoxate, titanium dioxide, zinc oxide, octisalate powder

Codecosme International 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 INGREDIENT

Active ingredients: Ethylhexyl Methoxycinnamate 7.00%, Titanium Dioxide 5.99%, Zinc Oxide 4.91%,

Ethylhexyl Salicylate 4.50%

INACTIVE INGREDIENT

Inactive ingredients: Bambusa Vulgaris Water, Diphenylsiloxy Phenyl Trimethicone,

Cyclopentasiloxane, Glycerin, Cyclohexasiloxane, Synthetic Fluorphlogopite, Diisostearyl Malate,

Methyl Methacrylate Crosspolymer, Pentylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone,

Niacinamide, Butylene Glycol, Trimethylsiloxysilicate, Dipropylene Glycol, Mica (CI 77019),

Magnesium Sulfate, Phenoxyethanol, Sorbitan Isostearate, Disteardimonium Hectorite, Aluminum

Hydroxide, Stearic Acid, Dimethicone, Fragrance(Parfum), Dimethicone Crosspolymer, Ultramarines

(CI 77007), Tin Oxide (CI 77861), Ethylhexylglycerin, Adenosine, Hydrogenated Castor Oil

Isostearate, Disodium EDTA, Triethoxycaprylylsilane, Iron Oxides (CI 77491), Biosaccharide Gum-4,

Milk Lipids, Pearl Powder, Sucrose Polycottonseedate, Betula Platyphylla Japonica Juice, Water,

Dimethicone/Vinyl Dimethicone Crosspolymer, Glyceryl Caprylate, Polyglutamic Acid

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: 1. If any of the following symptoms occur when using the product, stop using immediately

and consult a dermatologist. a) red spots, swelling, itchy rashes other skin irritations, etc. b) if a) occurs

after applying and being exposed to sunlight. 2. Do not use on wounds, inflamed skin, itchy areas, or

other infected areas. 3. Storage and handling: a) must close cap after use. b) Keep out of reach of

children. c) keep away from extreme heat, cold and direct sunlight. d) Avoid contact with eyes. In case

of contact with eyes, rinse thoroughly with water. 4. For external use only.

DESCRIPTION

Uses: UV Protection / Whitening / Anti-wrinkle. A cushion compact with ultra light texture that can

easily create a radiant complexion. Can be used as a makeup base and/or a highlighter.

Directions: 1. Gently soak the applicator puff on to mesh to use product. 2. Start from inner areas of the

face and work outwards. 3. Softly swipe over the skin to spread evenly before applying the foundation.

4. To use as a highlighter, apply on desired areas such as brow area, nose, cheekbones, forehead and

top of the chin. 5. To refill the product: Open outer cap, but close the inner cap and flip over the

product. While holding the product push down on the bottom sticker with both thumbs while having

outer cap open. Once the existing container is removed, replace it with a refill with the hinge set on the

dipped area which is on the left hand side.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MOONFLASH CUSHION

octinoxate, titanium dioxide, zinc oxide, octisalate powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7178 6 -0 50

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

0 .8 4 g in 12 g

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

Titanium Dio xide

0 .71 g in 12 g

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

ZINC CATION

0 .58 g in 12 g

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

O c tisa la te

0 .54 g in 12 g

Inactive Ingredients

Ingredient Name

Stre ng th

Glycerin (UNII: PDC6 A3C0 OX)

Diiso stea ryl Ma la te (UNII: QBS8 A3XZGQ)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7178 6 -0 50 -0 2 1 in 1 CARTON

10 /0 1/20 17

1

NDC:7178 6 -0 50 -0 1 12 g in 1 CONTAINER; Type 0 : No t a Co mbinatio n Pro duct

Codecosme International 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

10 /0 1/20 17

Labeler -

Codecosme International Co., Ltd. (689846614)

Registrant -

Codecosme International Co., Ltd. (689846614)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Co smecca Ko rea Co ., Ltd.

6 8 8 8 30 8 27

ma nufa c ture (7178 6 -0 50 )

Revised: 10/2017