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

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
Available from:
Leiluna LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sunscreen - 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
Authorization status:
OTC monograph final
Authorization number:
72841-101-01

TREEACTIV SAFFLOWER OLEOSOMES DAILY NATURAL MOISTURIZING

SUNSCREEN BROAD SPECTRUM SPF 30- zinc oxide lotion

Leiluna LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

TreeActiv Safflower Oleosomes Daily Natural Moisturizing Sunscreen Broad Spectrum SPF 30

Drug Facts

Active Ingredient(s)

Zinc Oxide 13%

Purpos e

Sunscreen

Us e(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 Oil

, 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

Other Information

Protect this product from excessive heat and direct sun

Questions or comments?

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

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)

Certified organic

TREEACTIV SAFFLOWER OLEOSOMES DAILY NATURAL MOISTURIZING

SUNSCREEN BROAD SPECTRUM SPF 30

zinc oxide lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:728 41-10 1

Route of Administration

TOPICAL

Leiluna LLC

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

ZINC OXIDE

130 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

WATER (UNII: 0 59 QF0 KO0 R)

ALKYL ( C12 -15) BENZO ATE (UNII: A9 EJ3J6 1HQ)

SAFFLO WER O IL (UNII: 6 5UEH26 2IS)

PO LYSO RBATE 6 0 (UNII: CAL22UVI4M)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

GLYCERIN (UNII: PDC6 A3C0 OX)

SUNFLO WER O IL (UNII: 3W1JG79 5YI)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

CO CO GLUCO SIDE (UNII: ICS79 0 225B)

ISO STEARIC ACID (UNII: X33R8 U0 0 6 2)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

LEUCO NO STO C/RADISH RO O T FERMENT FILTRATE (UNII: D2QHA0 3458 )

BETASIZO FIRAN (UNII: 2X51AD1X3T)

WITCH HAZEL (UNII: 10 1I4J0 U34)

XANTHAN GUM (UNII: TTV12P4NEE)

CITRIC ACID ACETATE (UNII: DSO12WL7AU)

PO LYHYDRO XYSTEARIC ACID ( 2 3 0 0 MW) (UNII: YXH47AOU0 F)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

FYTIC ACID (UNII: 7IGF0 S7R8 I)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:728 41-10 1-

50 mL in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n

Pro duc t

0 5/0 1/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt352

0 5/0 1/20 19

Labeler -

Leiluna LLC (080065214)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Island Kinetics, Inc. d.b.a. Co Valence Labo rato ries

9 59 7350 0 2

MANUFACTURE(728 41-10 1)

Revised: 4/2019

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