Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 0a6ce431-7370-44ff-839c-6e42d3a5bc10
Route
TOPICAL
Published
Effective Date 2014-05-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (186 mg)
Inactive Ingredients
Water Cyclomethicone 5 Butylene Glycol Glycerin Medium-chain Triglycerides Glyceryl Monostearate Peg-100 Stearate Cyclomethicone 6 Sorbitan Monostearate Dimethicone Polyacrylamide (10000 Mw) C13-14 Isoparaffin Laureth-7 Phenoxyethanol Caprylyl Glycol Ethylhexylglycerin Hexylene Glycol Imperata Cylindrica Root Polyethylene Glycol 400 Cetyl Alcohol Tocopherol Ascorbyl Palmitate Ascorbic Acid Citric Acid Monohydrate Xanthan Gum Polyester-7 Neopentyl Glycol Diheptanoate Teprenone Date Polygonum Aviculare Top Sodium Lactate Edetate Disodium Glycyrrhizinate Dipotassium Arabidopsis Thaliana Triethoxycaprylylsilane Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-04-22

Description

Active Ingredient: Zinc Oxide - 18.6%


Medication Information

Warnings and Precautions

Warnings:

For External Use only

Indications and Usage

Uses:

To help protect the skin from harmful UVA and UVB Rays

Description

Active Ingredient: Zinc Oxide - 18.6%

Section 50565-1

Keep out of reach of children

  • if swallowed, get medical help or contact a Poison Control Center right away
Section 50566-9

Stop use and ask a doctor

  • if severe skin irritation develops
Section 50567-7

When using this product

  • Keep out of eyes. If contact occurs, rinse with water
  • Discontinue use if irritation or redness occurs
Section 51727-6

Inactive Ingredients:

Water (Aqua), Cyclopentasiloxane, Butylene Glycol, Glycerin, Caprylic/Capric Triglyceride, Glyceryl Stearate, PEG-100 Stearate, Polyglyceryl-3 Polydimethylsiloxytethyl Dimethicone, Cyclohexasiloxane, Sorbitan Stearate, Dimethicone, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Phenoxyethanol, Caprylyl, Glycol, Ethylhexylglycerin, Hexylene Glycol, Imperata Cylindrica Root Extract, PEG-8, Carbomer, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Cetyl Alcohol, Lecithin, Tocopherol, Ascorbyl Palmitate, Ascorbic Acid, Citric Acid, Xanthan Gum, Polyester-7, Neopentyl Glycol Diheptanoate, Tocopheryl Linoleate/Oleate, Teprenone, Phoenix Dactylifera (Date) Fruit Extract, Polygonum Aviculare Extract, Sodium Lactate, Disodium EDTA, Dipotassium Glycrrihizate, Arabidopsis THaliana Extract, Plankton Extract, Micrococcus Lysate, Triethoxycaprylysilane, Iron Oxides (CI77491, CI77492, CI77499)

Section 51945-4

Section 55105-1

Purpose:Sunscreen

Section 55106-9

Active Ingredient:

Zinc Oxide - 18.6%


Structured Label Content

Indications and Usage (34067-9)

Uses:

To help protect the skin from harmful UVA and UVB Rays

Warnings and Precautions (34071-1)

Warnings:

For External Use only

Section 50565-1 (50565-1)

Keep out of reach of children

  • if swallowed, get medical help or contact a Poison Control Center right away
Section 50566-9 (50566-9)

Stop use and ask a doctor

  • if severe skin irritation develops
Section 50567-7 (50567-7)

When using this product

  • Keep out of eyes. If contact occurs, rinse with water
  • Discontinue use if irritation or redness occurs
Section 51727-6 (51727-6)

Inactive Ingredients:

Water (Aqua), Cyclopentasiloxane, Butylene Glycol, Glycerin, Caprylic/Capric Triglyceride, Glyceryl Stearate, PEG-100 Stearate, Polyglyceryl-3 Polydimethylsiloxytethyl Dimethicone, Cyclohexasiloxane, Sorbitan Stearate, Dimethicone, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Phenoxyethanol, Caprylyl, Glycol, Ethylhexylglycerin, Hexylene Glycol, Imperata Cylindrica Root Extract, PEG-8, Carbomer, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Cetyl Alcohol, Lecithin, Tocopherol, Ascorbyl Palmitate, Ascorbic Acid, Citric Acid, Xanthan Gum, Polyester-7, Neopentyl Glycol Diheptanoate, Tocopheryl Linoleate/Oleate, Teprenone, Phoenix Dactylifera (Date) Fruit Extract, Polygonum Aviculare Extract, Sodium Lactate, Disodium EDTA, Dipotassium Glycrrihizate, Arabidopsis THaliana Extract, Plankton Extract, Micrococcus Lysate, Triethoxycaprylysilane, Iron Oxides (CI77491, CI77492, CI77499)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose:Sunscreen

Section 55106-9 (55106-9)

Active Ingredient:

Zinc Oxide - 18.6%


Advanced Ingredient Data


Raw Label Data

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