Label: SUPER SENSITIVE SHIELD SPF 30- titanium dioxide and zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 68479-150-00, 68479-150-01, 68479-150-02, 68479-150-04 - Packager: Dermalogica, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 6, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
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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
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Directions
- Apply liberally 15 minutes before sun exposure.
- Reapply at least every two hours
- Use a water resistant sunscreen if swimming or sweating.
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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:
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- limit time in the sun, especially from 10 a.m. – 2 p.m.
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- wear long-sleeve shirts, pants, hats and sunglasses.
- Children under 6 months: ask a doctor.
- Other information
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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
- PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
SUPER SENSITIVE SHIELD SPF 30
titanium dioxide and zinc oxide lotionProduct 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)
