SUPER SENSITIVE SHIELD SPF 30- titanium dioxide and zinc oxide lotion

Super Sensitive Shield by

Drug Labeling and Warnings

Super Sensitive Shield by is a Otc medication manufactured, distributed, or labeled by Dermalogica, Inc., Cosway, Diamond Wipes. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Titanium Dioxide 7.0%, Zinc Oxide 9.0%.

Purpose

Sunscreen

Uses

• Helps prevent sunburn.
• If used as directed with other sun protection measures (see Directions), helps decrease 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 two 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 help decrease this risk, regularly use a sunscreen with a broad spectrum SPF 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-sleeve shirts, pants, hats and sunglasses.
• Children under 6 months: ask a doctor.

Other information

• Protect this product from excessive heat and direct sun.

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®

INGREDIENTS AND APPEARANCE

SUPER SENSITIVE SHIELD   SPF 30
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68479-150
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	70 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	90 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68479-150-02	1 in 1 CARTON	03/05/2012
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 68479-150-01	3 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/05/2012
3	NDC: 68479-150-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/05/2012
4	NDC: 68479-150-00	2 mL in 1 POUCH; Type 0: Not a Combination Product	03/05/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	03/05/2012

Labeler - Dermalogica, Inc. (177698560)

Establishment
Name	Address	ID/FEI	Business Operations
Cosway		620899877	MANUFACTURE(68479-150)

Establishment
Name	Address	ID/FEI	Business Operations
Diamond Wipes		161104729	MANUFACTURE(68479-150)