YADAH OH MY SUN SLUSH homosalate octocrylene octisalate avobenzone cream

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

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Active ingredient:
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)
Available from:
YADAH Co., Ltd.
INN (International Name):
HOMOSALATE
Composition:
HOMOSALATE 95 mg in 1 mL
Prescription type:
OTC DRUG
Authorization status:
OTC monograph not final

YADAH OH MY SUN SLUSH- homosalate, octocrylene, octisalate, avobenzone cream

YADAH 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.

----------

71026-004 YADAH OH MY SUN SLUSH

Homosalate 9.50%

Octocrylene 5.00%

Octisalate 4.50%

Avobenzone 3.00%

Sunscreen

Helps prevent sunburn

Apply liberally 15 minutes before sun exposure. Reapply at least every two hours

For external use only.

Do not use on damaged or broken skin.

When using this product, keep out of eyes. Rinse with water to remove.

Stop using and ask a doctor if rash occurs.

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control

center right away.

Opuntia Ficus-lndica Extract, Butylene Glycol, Behenyl Alcohol, Dicaprylyl Carbonate, 1,2-

Hexanediol, Bis-PEG-18 Methyl Ether Dimethyl Silane, Neopentyl Glycol Diheptanoate, Methyl

Methacrylate Crosspolymer, Silica, Water, Phenoxyethanol, Caprylyl Glycol, Carbomer, Fragrance,

Tromethamine, Dehydroxanthan Gum, Gellan Gum, Disodium EDTA, Betula Platyphylla Japonica Juice,

Portulaca Oleracea Extract, Butyrospermum Parkii (Shea) Seedcake Extract, Bambusa Arundinacea

Juice, Ethylhexylglycerin, Madecassoside

YADAH OH MY SUN SLUSH

homosalate, octocrylene, octisalate, avobenzone cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:710 26 -0 0 4

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HO MO SALATE (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S)

HOMOSALATE

9 5 mg in 1 mL

O CTO CRYLENE (UNII: 5A6 8 WGF6 WM) (OCTOCRYLENE - UNII:5A6 8 WGF6 WM)

OCTOCRYLENE

50 mg in 1 mL

O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

OCTISALATE

45 mg in 1 mL

AVO BENZO NE (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX)

AVOBENZONE

30 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

O PUNTIA FICUS-INDICA (UNII: 23Z8 7HTQ6 P)

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

DO CO SANO L (UNII: 9 G1OE216 XY)

DICAPRYLYL CARBO NATE (UNII: 6 0 9 A3V1SUA)

1,2 -HEXANEDIO L (UNII: TR0 46 Y3K1G)

BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9 C)

NEO PENTYL GLYCO L DIHEPTANO ATE (UNII: 5LKW3C543X)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

WATER (UNII: 0 59 QF0 KO0 R)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

CARBO XYPO LYMETHYLENE (UNII: 0 A5MM30 7FC)

TRO METHAMINE (UNII: 0 23C2WHX2V)

DEHYDRO XANTHAN GUM (UNII: 6 3ZP7I1BQO)

GELLAN GUM ( LO W ACYL) (UNII: 759 3U0 9 I4D)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

BETULA PLATYPHYLLA RESIN (UNII: 1B33PG6 N4K)

PURSLANE (UNII: M6 S8 40 WXG5)

SHEANUT (UNII: 8 4H6 HBP32L)

BAMBUSA BAMBO S WHO LE (UNII: 54FV35D6 0 A)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

MADECASSO SIDE (UNII: CQ2F5O6 YIY)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End Date

1

NDC:710 26 -0 0 4-

1 in 1 CARTON

0 8 /0 2/20 17

1

NDC:710 26 -0 0 4-0 1

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

YADAH Co., Ltd.

OTC mo no graph no t final

pa rt352

0 8 /0 2/20 17

Labeler -

YADAH Co., Ltd. (688289967)

Registrant -

YADAH Co., Ltd. (688289967)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Co smax, Inc

6 8 9 0 49 6 9 3

ma nufa c ture (710 26 -0 0 4)

Revised: 8/2017

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