Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 3bbcb812-fee9-3b00-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2016-02-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (2.54 g) Zinc Cation (5.99 g) Diethylamino Hydroxybenzoyl Hexyl Benzoate (2 g) Octocrylene (1 g) Octinoxate (7 g) Octisalate (5 g) Adenosine (0.04 g) Arbutin
Inactive Ingredients
Water Butylene Glycol Allantoin

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2019-11-19

Description

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


Medication Information

Warnings and Precautions

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

Indications and Usage
  • 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
Dosage and Administration

for external use only

Description

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

Section 50565-1

keep out of reach of the children

Section 51727-6

Water, Butylene Glycol, Allantoin, Etc.

Section 51945-4
Section 55105-1
  • Helps prevent sunburn
  • Provides high protection from sunburn
  • Helps keep moisturize
Section 55106-9

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


Structured Label Content

Indications and Usage (34067-9)
  • 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
Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

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

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

Water, Butylene Glycol, Allantoin, Etc.

Section 51945-4 (51945-4)
Section 55105-1 (55105-1)
  • Helps prevent sunburn
  • Provides high protection from sunburn
  • Helps keep moisturize
Section 55106-9 (55106-9)

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


Advanced Ingredient Data


Raw Label Data

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