SPF 40 by Empack Spraytech Inc

SPF 40 by

Drug Labeling and Warnings

SPF 40 by is a Otc medication manufactured, distributed, or labeled by Empack Spraytech Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPF 40- zinc oxide lotion 
Empack Spraytech 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.

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Active ingredient (w/w)

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.

SPF 40 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50021-600
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DILAURYL CITRATE (UNII: 5OYS3G306B)
GINKGO (UNII: 19FUJ2C58T)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)
PHYTATE SODIUM (UNII: 88496G1ERL)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: X323T6QO4M)
HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM LAURYL GLYCOL CARBOXYLATE (UNII: 8L0472VMYL)
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)
TOCOPHEROL (UNII: R0ZB2556P8)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYGLYCERYL-3 LAURATE (UNII: Y9ZSR39D0E)
POPULUS TREMULOIDES BARK (UNII: 5543O0CEID)
WATER (UNII: 059QF0KO0R)
BAMBUSA ARUNDINACEA STEM (UNII: NRA4497HC5)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
JOJOBA OIL (UNII: 724GKU717M)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50021-600-01	142 g in 1 TUBE; Type 0: Not a Combination Product	07/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/15/2021

Labeler - Empack Spraytech Inc (252047519)

Revised: 7/2021

Document Id: c707ba44-51db-7d45-e053-2a95a90a9c02

34390-5

Set id: c707c4df-94e6-1f23-e053-2995a90a2b4f

Version: 1

Effective Time: 20210715