SUPER SENSITIVE SHIELD  SPF 30- titanium dioxide and zinc oxide lotion 
Dermalogica, 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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Super Sensitive Shield
SPF 30

Drug Facts

Active Ingredients

Titanium Dioxide 7.0%, Zinc Oxide 9.0%.

Purpose

Sunscreen

Uses

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

Other information

Inactive ingredients

Water/Aqua/Eau, Cyclopentasiloxane, Dicaprylyl Ether, Butylene Glycol, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Stearic Acid, Aluminum Hydroxide, Dimethicone, Leuconostoc/Radish Root Ferment Filtrate, Camellia Sinensis Leaf Extract, Avena Sativa (Oat) Kernel Extract, Boerhavia Diffusa Root Extract, Oxothiazolidine, Citrullus Vulgaris (Watermelon) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Sodium Hyaluronate, Sodium PCA, Sodium Lactate, Lens Esculenta (Lentil) Fruit Extract, Ascorbyl Tetraisopalmitate, Lavandula Spica (Lavender) Flower Oil, Eucalyptus Globulus Leaf Oil, Lavandula Hybrida Oil, Sodium DNA, Tocopherol, Caprylic/Capric Triglyceride, Carbomer, Pentylene Glycol, Hydroxyphenyl Propamidobenzoic Acid, Bisabolol, Zingiber Officinale (Ginger) Fruit Extract, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Dipotassium Glycyrrhizate, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Dimethicone/ PEG-10/15 Crosspolymer, PEG/ PPG-18/18 Dimethicone, Glycerin, Cyclomethicone, Tocopheryl Acetate, Disodium EDTA, Sodium Benzoate, Sodium Chloride, Sodium Citrate, Ethylhexylglycerin, Phenoxyethanol.

Questions or comments

Call toll free
1-800-831-5150 in the US.

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

super
sensitive
shield

spf
30

broad
spectrum

NPN# 80031042

UltraCalming™

1.7 US FL OZ
50 mL e

dermalogica®

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
SUPER SENSITIVE SHIELD   SPF 30
titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-150
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide70 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide90 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Cyclomethicone 5 (UNII: 0THT5PCI0R)  
Dicaprylyl Ether (UNII: 77JZM5516Z)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone (UNII: 25G622K2RA)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
Dimethicone (UNII: 92RU3N3Y1O)  
Leuconostoc/Radish Root Ferment Filtrate (UNII: D2QHA03458)  
Green Tea Leaf (UNII: W2ZU1RY8B0)  
Oat (UNII: Z6J799EAJK)  
Boerhavia Diffusa Root (UNII: KR0SR09KYL)  
Oxothiazolidine (UNII: M6U1ZG59XD)  
Watermelon (UNII: 231473QB6R)  
Apple (UNII: B423VGH5S9)  
Hyaluronate Sodium (UNII: YSE9PPT4TH)  
Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
Sodium Lactate (UNII: TU7HW0W0QT)  
Lens Culinaris Fruit (UNII: ZYZ076G9JH)  
Ascorbyl Tetraisopalmitate (UNII: 47143LT58A)  
Lavender Oil (UNII: ZBP1YXW0H8)  
Eucalyptus Oil (UNII: 2R04ONI662)  
Lavandin Oil (UNII: 9RES347CKG)  
Tocopherol (UNII: R0ZB2556P8)  
Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E)  
Pentylene Glycol (UNII: 50C1307PZG)  
Hydroxyphenyl Propamidobenzoic Acid (UNII: 25KRT26H77)  
Levomenol (UNII: 24WE03BX2T)  
Ginger (UNII: C5529G5JPQ)  
Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)  
PEG/PPG-18/18 Dimethicone (UNII: 9H0AO7T794)  
Glycerin (UNII: PDC6A3C0OX)  
Cyclomethicone (UNII: NMQ347994Z)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Edetate Disodium (UNII: 7FLD91C86K)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Sodium Chloride (UNII: 451W47IQ8X)  
Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68479-150-021 in 1 CARTON03/05/2012
150 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:68479-150-013 mL in 1 BOTTLE; Type 0: Not a Combination Product03/05/2012
3NDC:68479-150-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product03/05/2012
4NDC:68479-150-002 mL in 1 POUCH; Type 0: Not a Combination Product03/05/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35203/05/2012
Labeler - Dermalogica, Inc. (177698560)
Establishment
NameAddressID/FEIBusiness Operations
Cosway620899877MANUFACTURE(68479-150)
Establishment
NameAddressID/FEIBusiness Operations
Diamond Wipes161104729MANUFACTURE(68479-150)

Revised: 12/2017
Document Id: e9be18c5-5b52-4187-9b70-e894fb8c33c9
Set id: a0d544bf-a7f7-49d9-80b5-f8eef1df392b
Version: 3
Effective Time: 20171206
 
Dermalogica, Inc.