TREEACTIV SAFFLOWER OLEOSOMES DAILY NATURAL MOISTURIZING SUNSCREEN BROAD SPECTRUM SPF 30- zinc oxide lotion

TreeActiv Safflower Oleosomes Daily Natural Moisturizing Sunscreen Broad Spectrum SPF 30 by

Drug Labeling and Warnings

TreeActiv Safflower Oleosomes Daily Natural Moisturizing Sunscreen Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Leiluna LLC, Island Kinetics, Inc. d.b.a. CoValence Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient(s)

Zinc Oxide 13%

Purpose

Sunscreen

Use(s)

• 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

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.

• Stop use and ask a doctor if rash occurs

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

Directions

• Apply liberally and evenly 15 minutes before sun exposure.
• Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours.
• Sun Protections Measures. Spending time in the sun increases our risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 15 or higher and other sun protection measures including:
  • limiting time in the sun especially from 10:00a.m. - 2:00 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses.

Chidren under 6 months: Ask a doctor

Inactive Ingredients

Aqua (Water), C12-15 Alkyl Benzoate, Carthamus Tinctorius (Safflower) Oleosomes, Polysorbate 60, Cetyl Alcohol, Glycerin, Helianthus Annuus (Sunflower) Seed Oil1, Cetearyl Alcohol, Coco-Glucoside, Caprylic/Capric Triglyceride, Leuconostoc/Radish Root Ferment Filtrate, Isostearic Acid, Sclerotium Gum, Caprylyl Glycol, Polyhydroxystearic Acid, Phytic Acid, Xanthan Gum, Hamamelis Virginiana (Witch Hazel) Water, Citric Acid, Alcohol

1 Certified organic

Other Information

• Protect this product from excessive heat and direct sun

Questions or comments?

CustomerCare@treeactiv.com | (888) 201-6444 | www.treeactiv.com

SPL UNCLASSIFIED SECTION

Distributed by: Leiluna LLC, Wilmington, DE 19807

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label

TreeActiv

EARTH GROWN, HAND CRAFTED

SAFFLOWER OLEOSOMES
DAILY NATURAL
MOISTURIZING SUNSCREEN

BROAD SPECTRUM SPF 30

1.7 fl oz (50 ml)

INGREDIENTS AND APPEARANCE

TREEACTIV SAFFLOWER OLEOSOMES DAILY NATURAL MOISTURIZING SUNSCREEN BROAD SPECTRUM SPF 30 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72841-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	130 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
SAFFLOWER OIL (UNII: 65UEH262IS)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
COCO GLUCOSIDE (UNII: ICS790225B)
ISOSTEARIC ACID (UNII: X33R8U0062)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
WITCH HAZEL (UNII: 101I4J0U34)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
FYTIC ACID (UNII: 7IGF0S7R8I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72841-101-01	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2019

Labeler - Leiluna LLC (080065214)

Establishment
Name	Address	ID/FEI	Business Operations
Island Kinetics, Inc. d.b.a. CoValence Laboratories		959735002	MANUFACTURE(72841-101)