SPL v1
SPL
SPL Set ID f84d8601-3526-4d85-9e38-30fd9e8e187b
Route
TOPICAL
Published
Effective Date 2021-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (15 g)
Inactive Ingredients
Water Coco-caprylate Glycerin Sorbitan Olivate C15-19 Alkane Alkyl (c12-15) Benzoate Cetearyl Olivate Coco Glucoside Xylitylglucoside Coconut Alcohol Zinc Sulfate Anhydroxylitol Jasminum Officinale Fruit Arnica Montana Flower Hypnea Musciformis Niacinamide Vitis Vinifera Leaf Inula Helenium Root Hyaluronate Sodium Radish Polyhydroxystearic Acid Stearate Trimethylolpropane Cetyl Ethylhexanoate Phytate Sodium Xanthan Gum Caprylhydroxamic Acid Glyceryl Monocaprylate Benzyl Alcohol Benzoic Acid Geraniol Linalool, (+/-)- Limonene, (+)- Eugenol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-08-02

Description

Zinc Oxide, 15%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide, 15%

Uses

Helps prevent sunburn

Section 42229-5

Distributed by Clark's Botanicals, LLC

Bronxville, NY

clarksbotanicals.com

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 rash occurs

Section 50567-7

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

Section 50570-1

Do not use on damaged or broken skin

Section 51945-4

Clark's Botanicals

Invisible Hero SPF 30

Anti-Aging Sunscreen with Hyaluronic Acid

Broad Spectrum SPF 30 PA+++

Poids Net Wt. 1.7 fl. oz.| 50 mL

Warnings

For external use only

Directions
  • Apply liberally at least 15 minutes before sun exposure
  • Apply as the last step in your skincare routine
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours

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 of 15 or higer and other sun protection measures includuing:

- Limit time in the sun, especailly from 10 AM to 2 PM

- Wear long-sleeve shirts, pants, hats, and sunglasses



  • Children under 6 months: Ask a doctor
Other Warnings

Protect this product from excessive heat and direct sun

Active Ingredient

Zinc Oxide, 15%

Inactive Ingredients

Water (Aqua), Coco-Caprylate, Glycerin, Sorbitan Olivate, C15-19 Alkane, C12-15 Alkyl Benzoate, Cetearyl Olivate, Coco-Glucoside, Xylitylglucoside, Coconut Alcohol, Zinc Sulfate, Anhydroxylitol, Jasminum Officinale (Jasmine) Extract, Arnica Montana (Arnica) Flower Extract, Hypnea Musciformis (Algae) Extract, Niacinamide, Vitis Vinifera (Grape) Leaf Extract, Inula Helenium (Elecampane) Extract, Sodium hyaluronate, Radish Root Ferment Filtrate, Polyhydroxystearic Acid, Trimethylolpropane Triethylhexanoate, Cetyl Ethylhexanoate, Sodium Phytate, Xanthan Gum, Caprylhydroxamic Acid, Glyceryl Caprylate, Benzyl Alcohol, Benzoic Acid, Natural Fragrance, Geraniol, Linalool, d -Limonene, Eugenol

Questions Or Comments

Call 1-917-970-1250 (9 AM to 5 PM ET)


Structured Label Content

Uses

Helps prevent sunburn

Section 42229-5 (42229-5)

Distributed by Clark's Botanicals, LLC

Bronxville, NY

clarksbotanicals.com

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 rash occurs

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 51945-4 (51945-4)

Clark's Botanicals

Invisible Hero SPF 30

Anti-Aging Sunscreen with Hyaluronic Acid

Broad Spectrum SPF 30 PA+++

Poids Net Wt. 1.7 fl. oz.| 50 mL

Purpose

Sunscreen

Warnings

For external use only

Directions
  • Apply liberally at least 15 minutes before sun exposure
  • Apply as the last step in your skincare routine
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours

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 of 15 or higer and other sun protection measures includuing:

- Limit time in the sun, especailly from 10 AM to 2 PM

- Wear long-sleeve shirts, pants, hats, and sunglasses



  • Children under 6 months: Ask a doctor
Other Warnings

Protect this product from excessive heat and direct sun

Active Ingredient

Zinc Oxide, 15%

Inactive Ingredients

Water (Aqua), Coco-Caprylate, Glycerin, Sorbitan Olivate, C15-19 Alkane, C12-15 Alkyl Benzoate, Cetearyl Olivate, Coco-Glucoside, Xylitylglucoside, Coconut Alcohol, Zinc Sulfate, Anhydroxylitol, Jasminum Officinale (Jasmine) Extract, Arnica Montana (Arnica) Flower Extract, Hypnea Musciformis (Algae) Extract, Niacinamide, Vitis Vinifera (Grape) Leaf Extract, Inula Helenium (Elecampane) Extract, Sodium hyaluronate, Radish Root Ferment Filtrate, Polyhydroxystearic Acid, Trimethylolpropane Triethylhexanoate, Cetyl Ethylhexanoate, Sodium Phytate, Xanthan Gum, Caprylhydroxamic Acid, Glyceryl Caprylate, Benzyl Alcohol, Benzoic Acid, Natural Fragrance, Geraniol, Linalool, d -Limonene, Eugenol

Questions Or Comments (Questions or Comments)

Call 1-917-970-1250 (9 AM to 5 PM ET)


Advanced Ingredient Data


Raw Label Data

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