De-listing [74741-1001-2] YERMA SUN ESSENCE TUBE+OUTER BOX

YERMA SUN ESSENCE by

Drug Labeling and Warnings

YERMA SUN ESSENCE by is a Otc medication manufactured, distributed, or labeled by MPRBRAIN CO.LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

YERMA SUN ESSENCE- octinoxate, homosalate, octisalate, octocrylene cream 
MPRBRAIN 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.

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De-listing
[74741-1001-2] YERMA SUN ESSENCE
TUBE+OUTER BOX

Active Ingredients

Octinoxate 6.75 %

Homosalate 4.5 %

Octisalate 3.6 %

Octocrylene 3.6 %

Stop use and ask a doctor

if rash occurs

Do not use

on damaged or broken skin.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Sunscreen

When using this product

keep out of eyes. Rinse with water to remove.

Directions

apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water-resistant sunscreen if swimming or sweating children under 6months : Ask a doctor

Warnings

Skin Cancer/Skin Aging Alert Spending time in the sun increases your riskof skin cancer and early aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only.

Uses

helps prevent sunburn

Other information

protect this product from excessive heat and direct sun

Inactive ingredients

Water, Alcohol Denat., 4-Methylbenzylidene Camphor, BisEthylhexyloxyphenol Methoxyphenyl Triazine, Dipropylene Glycol, Isoamyl P-Methoxycinnamate, Xylitol, Bis-PEG-18 Methyl Ether Dimethyl Silane, Tapioca Starch, Cyclopentasiloxane, Cetearyl Alcohol, Potassium Cetyl Phosphate, Silica Dimethyl Silylate, Sodium Carbomer, Ammonium Acryloyldimethyltaurate/VP Copolymer, Xanthan Gum, Tocopheryl Acetate, Phenoxyethanol, Chlorphenesin

YERMA SUN ESSENCE 
octinoxate, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74741-1001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.8 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.375 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	2.25 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.8 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
BEMOTRIZINOL (UNII: PWZ1720CBH)
AMILOXATE (UNII: 376KTP06K8)
BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
WATER (UNII: 059QF0KO0R)
ENZACAMENE (UNII: 8I3XWY40L9)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
XYLITOL (UNII: VCQ006KQ1E)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALCOHOL (UNII: 3K9958V90M)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
STARCH, TAPIOCA (UNII: 24SC3U704I)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74741-1001-2	1 in 1 BOX	03/26/2021
1	NDC: 74741-1001-1	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/26/2021	05/11/2021

Labeler - MPRBRAIN CO.LTD (689605062)

Establishment
Name	Address	ID/FEI	Business Operations
MPRBRAIN CO.LTD		689605062	manufacture(74741-1001)

Revised: 5/2021

Document Id: c204870f-9a51-3f33-e053-2a95a90aed5b

34390-5

Set id: be685a4c-f3ad-6c21-e053-2995a90a3af2

Version: 2

Effective Time: 20210510