MULTI PROTECTION UV BOUNCER

Main information

  • Trade name:
  • MULTI PROTECTION UV BOUNCER- octinoxate, octocrylene, octisalate cream
  • Composition:
  • Octinoxate 3.5 g in 50 mL
  • Administration route:
  • TOPICAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MULTI PROTECTION UV BOUNCER- octinoxate, octocrylene, octisalate cream
    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:
  • 71786-010-01, 71786-010-02
  • Last update:
  • 21-06-2019

Summary of Product characteristics: dosage, interactions, side effects

MULTI PROTECTION UV BOUNCER- octinoxate, octocrylene, octisalate cream

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%, Octocrylene 5.00%, Ethylhexyl Salicylate

4.50%

INACTIVE INGREDIENT

Inactive ingredients: Water, Alcohol Denat., Butylene Glycol, Butyl Methoxydibenzoylmethane, Bis-

Ethylhexyloxyphenol Methoxyphenyl Triazine, Silica, Methyl Methacrylate Crosspolymer,

Dimethicone, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Acrylates/C10-30 Alkyl

Acrylate, Crosspolymer, Fragrance, Isohexadecane, Caprylyl Glycol, Potassium Hydroxide,

Polysorbate 80, Phenoxyethanol, 1,2-Hexanediol, Ethylhexylglycerin, BHT, Citrus Aurantifolia (Lime)

Oil, Disodium EDTA, Buddleja Axillaris Leaf Extract, Phyllostachis Bambusoides Juice, Malpighia

Emarginata (Acerola) Fruit Extract, Propylene Glycol, Rosmarinus Officinalis (Rosemary) Leaf Extract,

Salvia Officinalis (Sage) Leaf Extract, Cucumis Sativus (Cucumber) Fruit Extract, Sorbaria Sorbifolia

Bark/Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Carex Humillis Root Extract, Nelumbo

Nucifera Flower Extract, Lilium Candidum Bulb Extract, Alcohol, Syringa Vulgaris (Lilac) Extract,

Glycine, Serine, Glutamic Acid, Saussurea Involucrata Extract, Aspartic acid, Leucine, Camellia

Sinensis Leaf Extract, Alanine, Lysine, Arginine, Tyrosine, Phenylalanine, Threonine, Proline, Valine,

Isoleucine, Aloe Barbadensis Leaf Extract, Psidium Guajava Leaf Extract, Abronia Villosa Leaf

Extract, Cinchona Succirubra Bark Extract, Chenopodium Quinoa Seed Extract, Histidine, Methionine,

Cysteine, Rhodiola Rosea Root Extract, Oxygen

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: A cooling and moisturizing UV protector/makeup primer. When applied, it protects the skin from

UV rays and leaves a beautiful sheen. Contains internationally renowned Korean Jeju hypoxic water and

British Harrogate sparkling water.

Directions: Pump appropriate amount of the product onto your hands and apply on the entire face in

outward strokes using a sponge or fingertips. If required, reapply it on areas that are vulnerable to

sunlight such as cheekbones, nasal bridge, and forehead. Close cap after use.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MULTI PROTECTION UV BOUNCER

octinoxate, octocrylene, octisalate cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7178 6 -0 10

Route of Administration

TOPICAL

Codecosme International Co., Ltd.

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

3.5 g in 50 mL

O cto crylene (UNII: 5A6 8 WGF6 WM) (OCTOCRYLENE - UNII:5A6 8 WGF6 WM)

O c to c ryle ne

2.5 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

2.25 g in 50 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

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

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7178 6 -0 10 -0 2

1 in 1 CARTON

10 /0 1/20 17

1

NDC:7178 6 -0 10 -0 1

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

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 10 )

Revised: 10/2017