D-ONE BY TAMDOAN SUNSCREEN 50: Package Insert and Label Information

D-ONE BY TAMDOAN SUNSCREEN 50- titanium dioxide, zinc oxide, diethylamino hydroxybenzoyl hexyl benzoate, octocrylene, octinoxate, octisalate, adenosine and arbutin cream
DRAN CO.,LTD

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Titanium dioxide, Zinc Oxide, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Adenosine, Arbutin

Water, Butylene Glycol, Allantoin, Etc.

  • Helps prevent sunburn
  • Provides high protection from sunburn
  • Helps keep moisturize

keep out of reach of the children

  • Use as foundation after basic skin care routine or right afternoon when needed (can use before and after makeup)
  • Apply by pressing the puff into the moistened sponge and patting the puff onto the face

1. Do not use in the following cases(Eczema and scalp wounds)
2.Side Effects
1)Due to the use of this product if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your pharmacist or doctor
3.General Precautions
1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately
2)This product is for exeternal use only. Do not use for internal use
4.Storage and handling precautions
1)If possible, avoid direct sunlight and store in cool and area of low humidity
2)In order to maintain the quality of the product and avoid misuse
3)Avoid placing the product near fire and store out in reach of children

for external use only

package label
(click image for full-size original)
D-ONE BY TAMDOAN SUNSCREEN 50
titanium dioxide, zinc oxide, diethylamino hydroxybenzoyl hexyl benzoate, octocrylene, ethylhexyl methoxycinnamate, ethylhexyl salicylate, adenosine, arbutin cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70931-0001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 2.54 g in 100 g
ZINC OXIDE (ZINC CATION) ZINC CATION 5.99 g in 100 g
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE) DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE 2 g in 100 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 1 g in 100 g
OCTINOXATE (OCTINOXATE) OCTINOXATE 7 g in 100 g
OCTISALATE (OCTISALATE) OCTISALATE 5 g in 100 g
ADENOSINE (ADENOSINE) ADENOSINE 0.04 g in 100 g
ARBUTIN (ARBUTIN) ARBUTIN 2 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
BUTYLENE GLYCOL
ALLANTOIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70931-0001-1 40 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/19/2019
Labeler — DRAN CO.,LTD (689516973)
Registrant — DRAN CO.,LTD (689516973)
Establishment
Name Address ID/FEI Operations
DRAN CO.,LTD 689516973 manufacture (70931-0001)

Revised: 11/2019 DRAN CO.,LTD

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