Herban Roots Sunscreen Broad Spectrum SPF 30

Herban Roots Sunscreen Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Herban Roots Sunscreen Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Cosmetic Enterprise Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HERBAN ROOTS SUNSCREEN BROAD SPECTRUM SPF 30- zinc oxide cream 
Cosmetic Enterprise Ltd

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Herban Roots Sunscreen Broad Spectrum SPF 30

Active Ingredient Purpose

Zinc Oxide 14.57%........Sunscreen

Uses

• Helps prevent Sunburn
• If used as as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if rash occurs.

Warnings

For external use only

Do not use on damaged or broken skin

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

Directions

• Apply liberally 15 minutes before sun exposure
• Reapply:
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • 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 higher and other sun protection measures including:
  • limited time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: ask a doctor

Inactive Ingredients

Organic High Oleic Sunflower Oil, Organic Coconut Oil, Beeswax, Organic Shea Butter, Tocopherols, Fragrance (All natural), Carrot Seed Oil.

Herban roots

Chemical Free

Sunscreen Broad Spectrum SPF 30

Water Resistant (80 muinutes)

Safe for the whole Family

Sheer, Non Greasy Coverage

Light Tropical Scent

4.0 FL OZ (118 mL)

HERBAN ROOTS SUNSCREEN BROAD SPECTRUM SPF 30 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56152-5013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	14.57 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)
COCONUT OIL (UNII: Q9L0O73W7L)
YELLOW WAX (UNII: 2ZA36H0S2V)
CARROT SEED OIL (UNII: 595AO13F11)
SHEA BUTTER (UNII: K49155WL9Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56152-5013-1	118 mL in 1 TUBE; Type 0: Not a Combination Product	09/14/2018	04/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/14/2018	04/01/2021

Labeler - Cosmetic Enterprise Ltd (017701475)

Revised: 10/2023

Document Id: 082f555f-7aab-8f05-e063-6294a90abfa9

34390-5

Set id: e90fb73e-f0d5-3ee3-e053-2a95a90a3268

Version: 2

Effective Time: 20231020