Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 4f639436-d06f-45fb-9946-703d61e357b5
Route
TOPICAL
Published
Effective Date 2016-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (186 mg)
Inactive Ingredients
Water Cyclomethicone 5 Butylene Glycol Glycerin Glyceryl Monostearate Peg-100 Stearate Cyclomethicone 6 Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Sorbitan Monostearate Dimethicone Cetyl Alcohol Medium-chain Triglycerides Shea Butter Polyacrylamide (10000 Mw) C13-14 Isoparaffin Hyaluronate Sodium Glycyrrhizinate Dipotassium Physalis Angulata Teprenone Leontopodium Alpinum Flowering Top Polygonum Aviculare Top Imperata Cylindrica Root Arabidopsis Thaliana Camellia Sinensis Flower Phoenix Reclinata Fruit Sodium Lactate Palmitoyl Tripeptide-1 Palmitoyl Tetrapeptide-7 Aloe Vera Leaf Lecithin, Soybean Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Polysorbate 20 Phenoxyethanol Caprylyl Glycol Ethylhexylglycerin Hexylene Glycol Laureth-7 Xanthan Gum Carboxypolymethylene Polyethylene Glycol 400 Tocopherol Ascorbyl Palmitate Ascorbic Acid Citric Acid Monohydrate Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-07-11

Description

Active Ingredients: Zinc Oxide - 18.6%


Medication Information

Warnings and Precautions

Warnings: For external use only.

Indications and Usage

Uses:

  • High protection against sunburn.
  • Higher SPF gives more sunburn protection.
  • 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 value of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10am - 2pm.
  • Wear long sleeved shirts, pants, hats and sunglasses.
Dosage and Administration

Directions:

  • Apply generously 15 minutes before su exposure.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply as needed or after towel drying, swimming or perspiring.
  • Children under 6 months of age: ask a doctor.
Description

Active Ingredients: Zinc Oxide - 18.6%

Section 44425-7

Protect the product in this container from excessive heat and direct sun.

Section 50565-1

Keep out of reach of children

Section 50566-9

Stop use and ask a doctor if rash occurs. Do not use on damaged or broken skin.

Section 50567-7

When using this product keep out of eyes.Rinse with water to remove.

Section 51727-6

Water (Aqua), Cyclopentasiloxane, Butylene Glycol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Cyclohexasiloxane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Sorbitan Stearate, Dimethicone, Cetyl Alcohol, Caprylic/Capric Triglyceride, Organic Butyrospermum Parkii (Shea) Butter, Polyacrylamide, C13-14 Isoparaffin, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Sodium Hyaluronate, Dipotassium Glycyrrhizate, Tocopheryl Linoleate/Oleate, Physalis Angulata Extract, Teprenone, Leontopodium Alpinum Meristem Cell Culture, Polygonum Aviculare Extract, Imperata Cylindrica Root Extract, Arabidopsis Thaliana Extract, Plankton Extract, Micrococcus Lysate, Organic Camellia Sinensis Leaf Extract, Phoenix Dactylifera (Date) Fruit Extract, Sidium Lactete, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Organic Aloe Barbadensis Leaf Juice, Lecithin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate-20, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Laureth-7, Xanthan Gum, Carbomer, PEG-8, Tocopherol, Ascorbyl Palmitate, Ascorbic Acid, Citric Acid, Disodium EDTA.

Section 51945-4

Made in USA

Distributed by OJAS, LLC

OjasSkin.com

Section 55105-1

Purpose: Sunscreen

Section 55106-9

Active Ingredients: Zinc Oxide - 18.6%

Section 60561-8

Other Information

  • Sun Alert: limiting sun exposure, wearing protective clothing and using sunscreen may reduce the risk of skin aging, skin cancer and other harmful effects of the sun.

Structured Label Content

Indications and Usage (34067-9)

Uses:

  • High protection against sunburn.
  • Higher SPF gives more sunburn protection.
  • 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 value of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10am - 2pm.
  • Wear long sleeved shirts, pants, hats and sunglasses.
Dosage and Administration (34068-7)

Directions:

  • Apply generously 15 minutes before su exposure.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply as needed or after towel drying, swimming or perspiring.
  • Children under 6 months of age: ask a doctor.
Warnings and Precautions (34071-1)

Warnings: For external use only.

Section 44425-7 (44425-7)

Protect the product in this container from excessive heat and direct sun.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs. Do not use on damaged or broken skin.

Section 50567-7 (50567-7)

When using this product keep out of eyes.Rinse with water to remove.

Section 51727-6 (51727-6)

Water (Aqua), Cyclopentasiloxane, Butylene Glycol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Cyclohexasiloxane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Sorbitan Stearate, Dimethicone, Cetyl Alcohol, Caprylic/Capric Triglyceride, Organic Butyrospermum Parkii (Shea) Butter, Polyacrylamide, C13-14 Isoparaffin, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Sodium Hyaluronate, Dipotassium Glycyrrhizate, Tocopheryl Linoleate/Oleate, Physalis Angulata Extract, Teprenone, Leontopodium Alpinum Meristem Cell Culture, Polygonum Aviculare Extract, Imperata Cylindrica Root Extract, Arabidopsis Thaliana Extract, Plankton Extract, Micrococcus Lysate, Organic Camellia Sinensis Leaf Extract, Phoenix Dactylifera (Date) Fruit Extract, Sidium Lactete, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Organic Aloe Barbadensis Leaf Juice, Lecithin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate-20, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Laureth-7, Xanthan Gum, Carbomer, PEG-8, Tocopherol, Ascorbyl Palmitate, Ascorbic Acid, Citric Acid, Disodium EDTA.

Section 51945-4 (51945-4)

Made in USA

Distributed by OJAS, LLC

OjasSkin.com

Section 55105-1 (55105-1)

Purpose: Sunscreen

Section 55106-9 (55106-9)

Active Ingredients: Zinc Oxide - 18.6%

Section 60561-8 (60561-8)

Other Information

  • Sun Alert: limiting sun exposure, wearing protective clothing and using sunscreen may reduce the risk of skin aging, skin cancer and other harmful effects of the sun.

Advanced Ingredient Data


Raw Label Data

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