Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 4903b4f0-1e39-66ae-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2013-11-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (11.25 g) Zinc Oxide (4.85 g)
Inactive Ingredients
Water Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-02-20

Description

Titanium Dioxide, Zinc Oxide


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 druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr 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
  • Apply liberally 15 minutes before sun exposure.
  • Children under 6 months ask a doctor.
  • Reapply after water activity.

Dosage and Administration

for external use only

Description

Titanium Dioxide, Zinc Oxide

Section 50565-1

keep out or reach of the children



Section 51727-6

Water, Dicaprylyl Carbonate, Polyglyceryl-3 Diisostearate, Glycerin, Polyglyceryl-2 Dipolyhydroxystearate, Stearic Acid, Aluminum Hydroxide, Helianthus Annuus (Sunflower) Seed Oil, Centella Asiatica Extract, Mangifera Indica (Mango) Seed Butter, Cocos Nucifera (Coconut) Oil, Hippophae Rhamnoides Seed Oil, Rosa Canina Fruit Extract, Zanthoxylum Piperitum Fruit Extract, Pulsatilla Koreana Extract, Usnea Barbata (Lichen) Extract, Lactobacillus/Hibiscus Sabdariffa FlowerFerment Filtrate, Voacanga Africana Seed Extract, Distarch Phosphate, Sodium Chloride, Glyceryl Caprylate, Silica, 1,2-Hexanediol, Ethyl Ferulate, Hydrolyzed Jojoba Esters, Geranium Maculatum Oil

Section 51945-4

Section 55105-1

Skin Protectant - Sun Block

Section 55106-9

Titanium Dioxide, Zinc Oxide


Structured Label Content

Indications and Usage (34067-9)
  • Apply liberally 15 minutes before sun exposure.
  • Children under 6 months ask a doctor.
  • Reapply after water activity.

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 druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr 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 or reach of the children



Section 51727-6 (51727-6)

Water, Dicaprylyl Carbonate, Polyglyceryl-3 Diisostearate, Glycerin, Polyglyceryl-2 Dipolyhydroxystearate, Stearic Acid, Aluminum Hydroxide, Helianthus Annuus (Sunflower) Seed Oil, Centella Asiatica Extract, Mangifera Indica (Mango) Seed Butter, Cocos Nucifera (Coconut) Oil, Hippophae Rhamnoides Seed Oil, Rosa Canina Fruit Extract, Zanthoxylum Piperitum Fruit Extract, Pulsatilla Koreana Extract, Usnea Barbata (Lichen) Extract, Lactobacillus/Hibiscus Sabdariffa FlowerFerment Filtrate, Voacanga Africana Seed Extract, Distarch Phosphate, Sodium Chloride, Glyceryl Caprylate, Silica, 1,2-Hexanediol, Ethyl Ferulate, Hydrolyzed Jojoba Esters, Geranium Maculatum Oil

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Skin Protectant - Sun Block

Section 55106-9 (55106-9)

Titanium Dioxide, Zinc Oxide


Advanced Ingredient Data


Raw Label Data

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