YADAH OH MY SUN BLOCK- octinoxate, titanium dioxide, octocrylene, 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.

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71026-001

Octinoxate 7.50%
Titanium Dioxide 2.13%
Octocrylene 2.00%
Avobenzone 1.20%

Sunscreen

Helps prevent sunburn

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

Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses

Ask a doctor to use for children under 6 months

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.

Water, Ethylhexyl Methoxycinnamate, Butylene Glycol, Cyclopentasiloxane, Glycerin, Dicaprylyl Carbonate, Titanium Dioxide (CI 77891), Ethylhexyl Palmitate, Octocrylene, Cyclohexasiloxane, Methyl Methacrylate Crosspolymer, Cetearyl Alcohol, Butyl Methoxydibenzoylmethane, Triceteareth-4 Phosphate, Glycol Stearate, Glyceryl Stearate, Potassium Cetyl Phosphate, PEG-2 Stearate, PEG-100 Stearate, Silica, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Glyceryl Caprylate, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Aminomethyl Propanol, Caprylyl Glycol, Xanthan Gum, Dimethicone, Disodium EDTA, Opuntia Ficus-Indica Stem Extract, Anthemis Nobilis Flower Water, Aloe Barbadensis Leaf Juice, Diospyros Kaki Leaf Extract, 1,2-Hexanediol, Ethyl Hexanediol, Propylene Glycol, Benzyl Alcohol, Dehydroacetic Acid, Solanum Tuberosum (Potato) Pulp Extract

image description

YADAH OH MY SUN BLOCK 
octinoxate, titanium dioxide, octocrylene, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71026-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.75 mg  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.065 mg  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 mg  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.6 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
GLYCERIN (UNII: PDC6A3C0OX)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
TRICETEARETH-4 PHOSPHATE (UNII: 69534Y66NO)  
GLYCOL STEARATE (UNII: 0324G66D0E)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PEG-2 STEARATE (UNII: 94YQ11Y95F)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
XANTHAN GUM (UNII: TTV12P4NEE)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
OPUNTIA FICUS-INDICA (UNII: 23Z87HTQ6P)  
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
LAVANDULA ANGUSTIFOLIA WHOLE (UNII: 51217XIL5L)  
DIOSPYROS KAKI LEAF (UNII: Q71GF9OBNO)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
ETHOHEXADIOL (UNII: M9JGK7U88V)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
POTATO PULP (UNII: 844I2DX0IS)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71026-001-021 in 1 CARTON01/02/201812/10/2018
1NDC:71026-001-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/02/201812/10/2018
Labeler - YADAH Co., Ltd. (688289967)
Registrant - YADAH Co., Ltd. (688289967)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(71026-001)

Revised: 12/2018
 
YADAH Co., Ltd.