SUNSCREEN BROAD SPECTRUM SPF 30 LIGHT TROPICAL SCENT- zinc oxide cream

Sunscreen Broad Spectrum SPF 30 Light Tropical Scent by

Drug Labeling and Warnings

Sunscreen Broad Spectrum SPF 30 Light Tropical Scent by is a Otc medication manufactured, distributed, or labeled by Cosmetic Enterprises Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose

Zinc Oxide 14.57% Sunscreen

PURPOSE

Uses

• Helps prevent sunburn
• If used 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

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

INDICATIONS & USAGE

Stop use and ask a doctorif rash occurs.

WARNINGS

Warnings

For External use only

Do not useon damaged or broken skin

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

DOSAGE & ADMINISTRATION

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:
• 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 INGREDIENT

Inactive Ingredients

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

OTHER SAFETY INFORMATION

Other information

• Protect this product from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

Herban Roots

Chemical Free

Sunscreen Broad Spectrum SPF 30

Water resistant (80 minutes)

Safe for the Whole Family

Sheer, Non-Greasy Coverage

Light Tropical Scent

4.0 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

SUNSCREEN BROAD SPECTRUM SPF 30 LIGHT TROPICAL SCENT 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56152-0101
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
YELLOW WAX (UNII: 2ZA36H0S2V)
SUNFLOWER OIL (UNII: 3W1JG795YI)
COCONUT OIL (UNII: Q9L0O73W7L)
TOCOPHEROL (UNII: R0ZB2556P8)
CARROT SEED OIL (UNII: 595AO13F11)
SHEA BUTTER (UNII: K49155WL9Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56152-0101-1	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/24/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/24/2022

Labeler - Cosmetic Enterprises Ltd (017701475)