INVISIBLE SHIELD FULL PHYSICAL TINTED SPF 52 BROAD SPECTRUM SUNSCREEN- titanium dioxide and zinc oxide lotion

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

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Active ingredient:
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP), Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)
Available from:
SENTÉ, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
- 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:
71398-012-01

INVISIBLE SHIELD FULL PHYSICAL TINTED SPF 52 BROAD SPECTRUM SUNSCREEN-

titanium dioxide and zinc oxide lotion

SENTÉ, 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.

----------

Invisible Shield Full Physical Tinted SPF 52 Broad Spectrum Sunscreen

Drug Facts

Active ingredients

Purpose

Titanium Dioxide 5.75%

Sunscreen

Zinc Oxide 11.15%

Sunscreen

Us es

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, Sodium Hydroxide, Propanediol, Caprylyl Glycol,

Caprylhydroxamic Acid, 1,2-Hexanediol, Disodium EDTA, Iron Oxides (CI 77491, CI 77492, CI

77499)

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

Tinted

Broad Spectrum

SPF 52 Sunscreen

PA++++

SHIELD

NET WT. 1.8 OZ/52 g

INVISIBLE SHIELD FULL PHYSICAL TINTED SPF 52 BROAD SPECTRUM

SUNSCREEN

titanium dioxide and zinc oxide lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7139 8 -0 12

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Tita nium Dio xide (UNII: 15FIX9 V2JP) (Titanium Dio xide - UNII:15FIX9 V2JP)

Titanium Dio xide

57.5 mg in 1 g

Zinc O xide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)

Zinc Oxide

111.5 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

Medium-Cha in Trig lycerides (UNII: C9 H2L21V7U)

Ca prylyl Trisilo xa ne (UNII: Q9 5M2P1KJL)

Stea reth-2 (UNII: V56 DFE46 J5)

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

Stea reth-2 1 (UNII: 53J3F32P58 )

Glycerin (UNII: PDC6 A3C0 OX)

Bio sa ccha ride Gum-4 (UNII: 9 XRL0 57X9 0 )

Fructo se (UNII: 6 YSS42VSEV)

Witha nia So mnifera Ro o t (UNII: V0 38 D6 26 IF)

Yea st, Unspecified (UNII: 3NY3SM6 B8 U)

CICHO RIUM INTYBUS ( CHICO RY) RO O T O LIGO SACCHARIDES (UNII: 38 AFY41EAR)

Ba tilo l (UNII: 39 YR6 6 1C4U)

Stea ric Acid (UNII: 4ELV7Z6 5AP)

Aluminum O xide (UNII: LMI26 O6 9 33)

Trietho xyca prylylsila ne (UNII: LDC331P0 8 E)

Xa ntha n Gum (UNII: TTV12P4NEE)

Fytic Acid (UNII: 7IGF0 S7R8 I)

Pro pa nedio l (UNII: 59 6 5N8 W8 5T)

Ca prylyl Glyco l (UNII: 0 0 YIU5438 U)

Ca prylhydro xa mic Acid (UNII: UPY8 0 5K9 9 W)

1,2 -Hexa nedio l (UNII: TR0 46 Y3K1G)

Edeta te Diso dium (UNII: 7FLD9 1C8 6 K)

Ferro so ferric O xide (UNII: XM0 M8 7F357)

Ferric O xide Red (UNII: 1K0 9 F3G6 75)

Ferric O xide Yello w (UNII: EX438 O2MRT)

So dium Hydro xide (UNII: 55X0 4QC32I)

SENTÉ, Inc.

Product Characteristics

Color

BROWN

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7139 8 -0 12-0 1

1 in 1 CARTON

0 5/15/20 19

1

52 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

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 5/15/20 19

Labeler -

SENT É, Inc. (079245446)

Revised: 2/2019

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