INVISIBLE SHIELD FULL PHYSICAL SPF 49 BROAD SPECTRUM SUNSCREEN- titanium dioxide and zinc oxide lotion

Invisible Shield Full Physical SPF 49 Broad Spectrum Sunscreen by

Drug Labeling and Warnings

Invisible Shield Full Physical SPF 49 Broad Spectrum Sunscreen by is a Otc medication manufactured, distributed, or labeled by SENTÉ, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Titanium Dioxide 5.75%	Sunscreen
Zinc Oxide 11.15%	Sunscreen

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

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 15 minutes before sun exposure
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating
• 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 value of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m.-2 p.m.
  • Wear long- sleeved shirts, pants, hats, and sunglasses.
• Children under 6 months of age:
  Ask a doctor

Inactive ingredients

Water (Aqua), Caprylic/Capric Triglyceride, Shea Butter Ethyl Esters, Caprylyl Methicone, Acetamidoethoxyethanol, Steareth-2, Polyhydroxystearic Acid, Steareth-21, Glycerin, Biosaccharide Gum-4, Fructose, Withania Somnifera Root Extract, Yeast Extract, Hydrolyzed Candida Saitoana Extract, Cichorium Intybus (Chicory) Root Extract, Batyl Alcohol, Stearic Acid, Alumina, Triethoxycaprylylsilane, Xanthan Gum, Phytic Acid, Propanediol, Caprylyl Glycol, Caprylhydroxamic Acid, 1,2-Hexanediol, Disodium EDTA

Other information

Protect the product in this container from excessive heat and direct sun

Questions or comments?

(800) 205-6774
www.sentelabs.com

PRINCIPAL DISPLAY PANEL - 52 g Tube Carton

SENTÉ®
Glycosaminoglycans

Invisible Shield
Full Physical

Broad Spectrum
SPF 49 Sunscreen

PA++++

SHIELD

NET WT. 1.8 OZ / 52 g

INGREDIENTS AND APPEARANCE

INVISIBLE SHIELD FULL PHYSICAL SPF 49 BROAD SPECTRUM SUNSCREEN 
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71398-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	57.5 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	111.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Caprylyl Trisiloxane (UNII: Q95M2P1KJL)
Steareth-2 (UNII: V56DFE46J5)
Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F)
Steareth-21 (UNII: 53J3F32P58)
Glycerin (UNII: PDC6A3C0OX)
Stearic Acid (UNII: 4ELV7Z65AP)
Aluminum Oxide (UNII: LMI26O6933)
Propanediol (UNII: 5965N8W85T)
Batilol (UNII: 39YR661C4U)
Caprylyl Glycol (UNII: 00YIU5438U)
Xanthan Gum (UNII: TTV12P4NEE)
Fructose (UNII: 6YSS42VSEV)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Fytic Acid (UNII: 7IGF0S7R8I)
Cichorium Intybus (Chicory) Root Oligosaccharides (UNII: 38AFY41EAR)
Caprylhydroxamic Acid (UNII: UPY805K99W)
Edetate Disodium (UNII: 7FLD91C86K)
Withania Somnifera Root (UNII: V038D626IF)
1,2-Hexanediol (UNII: TR046Y3K1G)
Yeast, Unspecified (UNII: 3NY3SM6B8U)
Biosaccharide Gum-4 (UNII: 9XRL057X90)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71398-011-01	1 in 1 CARTON	05/15/2019
1		52 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	05/15/2019

Labeler - SENTÉ, Inc. (079245446)