EVERYDAY UV PROTECTOR SUN SCREEN

Main information

  • Trade name:
  • EVERYDAY UV PROTECTOR SUN SCREEN- homosalate, octisalate, avobenzone, octocrylene cream
  • Composition:
  • Homosalate 1.05 g in 15 g
  • Administration route:
  • TOPICAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • EVERYDAY UV PROTECTOR SUN SCREEN- homosalate, octisalate, avobenzone, octocrylene 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:
  • 71882-010-01
  • Last update:
  • 21-06-2019

Summary of Product characteristics: dosage, interactions, side effects

EVERYDAY UV PROTECTOR SUN SCREEN- homosalate, octisalate, avobenzone,

octocrylene cream

Dermal Korea 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: Homosalate 7.00%, Ethylhexyl Salicylate 4.50%, Butyl Methoxydibenzoylmethane

3.00%, Octocrylene 1.00%

INACTIVE INGREDIENT

Inactive ingredients: Water, Alcohol Denat., Dipropylene Glycol, Methyl Methacrylate Crosspolymer,

Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Isoamyl p-Methoxycinnamate, Bis-PEG/PPG-20/5

PEG/PPG-20/5 Dimethicone, Methoxy PEG/PPG-25/4 Dimethicone, Acrylates/C10-30 Alkyl Acrylate

Crosspolymer, Caprylic/Capric Triglyceride, Dimethicone, Caprylyl Glycol, Fragrance, Sodium

Hydroxide, Ethylhexylglycerin, Centella Asiatica Extract, Adansonia Digitata Seed Extract, Aloe

Barbadensis Leaf Extract, 1,2-Hexanediol, BHT, Disodium EDTA, Phenoxyethanol

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: 1. Stop using if skin becomes red, swollen, itchy, etc during and after use. 2. Avoid using on

irritated or sunburned skin by direct sunlight 3. Stop using on troubled skin part including eczema or

dermatitis. 4. Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water. 5. Keep

away from the reach of baby and children. 6. Stored at room temperature only and keep away from direct

sunlight.

DESCRIPTION

Uses: In the last step of skin care, apply evenly to the areas which are exposed to ultraviolet such as

face, neck, arm, leg and so on.

Directions: It protects your skin from UVA/UVB and keeps your skin soft all day long without being

sticky!

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EVERYDAY UV PROTECTOR SUN SCREEN

homosalate, octisalate, avobenzone, octocrylene cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:718 8 2-0 10

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

Ho mo sa la te

1.0 5 g in 15 g

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

O c tisa la te

0 .6 7 g in 15 g

Avo benzo ne (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX)

Avo be nz o ne

0 .45 g in 15 g

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

O c to c ryle ne

0 .15 g in 15 g

Inactive Ingredients

Dermal Korea Co., Ltd

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

Dipro pylene Glyco l (UNII: E10 7L8 5C40 )

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:718 8 2-0 10 -0 1

15 g in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

10 /0 1/20 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 no t final

pa rt352

10 /0 1/20 17

Labeler -

Dermal Korea Co., Ltd (688990247)

Registrant -

Dermal Korea Co., Ltd (688990247)

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 (718 8 2-0 10 )

Revised: 11/2017