Tilley Endurables SPF 40: Package Insert and Label Information

TILLEY ENDURABLES SPF 40- zinc oxide lotion
Tilley Endurables, Inc

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.

Zinc Oxide 20.5%

Purpose

Sunscreen

Use

Helps prevent sunburn.

Warnings

For external use only.

Do not use on broken skin.

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. Topical. If swallowed, call a poison control centre or get medical help right away.

Directions

Adults, adolescents, and children over 6 months of age • Apply liberally and evenly 15 minutes before sun exposure • Reapply: • at least 2 hours • after 40 minutes of swimming or sweating • immediately after towel drying • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. — 2 p.m. and • wear long-sleeved shirts, pants, hats, and sunglasses.

Other information

Protect the product in this container from excessive heat and direct sun. May stain surfaces and fabrics.

Inactive ingredients

Aloe Barbadensis Leaf Juice, Ammonium Acryloyldimethyltaurate/VP Copolymer, Aqua/Water/Eau, Bambusa Arundinacea Stem Extract, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Dilauryl Citrate, Ethylhexylglycerin, Ginkgo Biloba Leaf Extract, Gluconolactone, Glycerin, Hydrogenated Methyl Abietate, Isopropyl Palmitate, Lauryl Glucoside, Leuconostoc/Radish Root Ferment Filtrate, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Methylcellulose, Octyldodecyl Citrate Crosspolymer, Phenoxyethanol, Polyglyceryl-4 Laurate, Polyhydroxystearic Acid, Populus Tremuloides Bark Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Lauryl Glucose Carboxylate, Sodium Phytate, Sodium Stearoyl Glutamate, Sorbitan Laurate, Tocopherol, Xanthan Gum

Questions?

1-800-ENDURES or visit www.tilley.com

SPF 40 Tilley Ensurables

BROAD SPECTRUM

UVA / UVB PROTECTION

MINERAL SUNSCREEN

WATER / SWEAT RESISTANT (40 MIN)

Net Wt. 5 oz. (142 g)

Refer to attachment, Label — Tilley SPF 40 for label artwork.

Label -- Tilley SPF 40
(click image for full-size original)
TILLEY ENDURABLES SPF 40
zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:81856-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 20.5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
DILAURYL CITRATE
GINKGO
POLYHYDROXYSTEARIC ACID (2300 MW)
METHYLCELLULOSE, UNSPECIFIED
PHYTATE SODIUM
GLUCONOLACTONE
GLYCERIN
OCTYLDODECYL CITRATE CROSSPOLYMER
HYDROGENATED METHYL ABIETATE
LAURYL GLUCOSIDE
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE
LONICERA JAPONICA FLOWER
ALOE VERA LEAF
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER
ETHYLHEXYLGLYCERIN
ISOPROPYL PALMITATE
LONICERA CAPRIFOLIUM FLOWER
PHENOXYETHANOL
SODIUM LAURYL GLYCOL CARBOXYLATE
SORBITAN MONOLAURATE
TOCOPHEROL
XANTHAN GUM
POLYGLYCERYL-3 LAURATE
POPULUS TREMULOIDES BARK
WATER
BAMBUSA ARUNDINACEA STEM
GREEN TEA LEAF
MEDIUM-CHAIN TRIGLYCERIDES
JOJOBA OIL
SODIUM STEAROYL GLUTAMATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:81856-001-01 142 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 06/30/2021
Labeler — Tilley Endurables, Inc (244150173)

Revised: 06/2021 Tilley Endurables, Inc

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