Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 42b5b8e8-33a8-4263-b8ff-f204948cfb37
Route
TOPICAL
Published
Effective Date 2017-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (186 mg)
Inactive Ingredients
Water Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Cyclomethicone Glycerin Glyceryl Monostearate Peg-100 Stearate Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Sorbitan Monostearate Dimethicone Cetyl Alcohol Lecithin, Soybean Imperata Cylindrica Root Polyacrylamide (10000 Mw) C13-14 Isoparaffin Carica Papaya Leaf Aloe Vera Leaf Peg-8 Caprylic/capric Glycerides Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Phenoxyethanol Caprylyl Glycol Ethylhexylglycerin Hexylene Glycol Laureth-7 Xanthan Gum Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-12-04

Description

Active Ingredients: Zinc Oxide - 18.6%


Medication Information

Warnings and Precautions

Warnings: For external use only.

Indications and Usage

Uses:

  • Provided high protection against sunburn.
  • Broad Spectrum (UVA and UVB) protection.
  • If used with directed with other sun protection measures,decreases the risk of skin cancer and early skin aging caused by sun. 
Dosage and Administration

Directions:

  • Apply generously 15 minutes before su exposure.
  • Reapply at least every 2 hours. After swimming or sweating. Immediately after towel drying.
  • Children under 6 months of age: ask a doctor.
Description

Active Ingredients: Zinc Oxide - 18.6%

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if rash or irritation occurs.

Section 50567-7

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

Section 51727-6

Water (Aqua), Cyclopentasiloxane, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Sorbitan Stearate, Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Cetyl Alcohol, Polyacrylamide, C13-14 Isoparaffin, Lecithine, Imperata Cylindrica Root Extract, Xanthan Gum, Aloe Barbadensis Leaf Juice, Carica Papaya (Papaya) Fruit Extract, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Laureth-7, Carbomer, PEG-8, Disodium EDTA.

Section 51945-4

Made in USA

Sun Research LLC

Santa Cruz, CA

www.burnoutsun.com

Section 53413-1

Call toll free 1-800-798-7970

Section 55105-1

Purpose: Sunscreen

Section 55106-9

Active Ingredients: Zinc Oxide - 18.6%

Section 60561-8

Other Information High sun protection product.


Structured Label Content

Indications and Usage (34067-9)

Uses:

  • Provided high protection against sunburn.
  • Broad Spectrum (UVA and UVB) protection.
  • If used with directed with other sun protection measures,decreases the risk of skin cancer and early skin aging caused by sun. 
Dosage and Administration (34068-7)

Directions:

  • Apply generously 15 minutes before su exposure.
  • Reapply at least every 2 hours. After swimming or sweating. Immediately after towel drying.
  • Children under 6 months of age: ask a doctor.
Warnings and Precautions (34071-1)

Warnings: For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash or irritation occurs.

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, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Sorbitan Stearate, Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Cetyl Alcohol, Polyacrylamide, C13-14 Isoparaffin, Lecithine, Imperata Cylindrica Root Extract, Xanthan Gum, Aloe Barbadensis Leaf Juice, Carica Papaya (Papaya) Fruit Extract, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Laureth-7, Carbomer, PEG-8, Disodium EDTA.

Section 51945-4 (51945-4)

Made in USA

Sun Research LLC

Santa Cruz, CA

www.burnoutsun.com

Section 53413-1 (53413-1)

Call toll free 1-800-798-7970

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 High sun protection product.


Advanced Ingredient Data


Raw Label Data

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