Label: TOTAL EYE CARE SPF 15- titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 68479-608-00, 68479-608-01, 68479-608-02 - 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 29, 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 ingredient
- Purpose
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Use
- 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 evenly 15 minutes before sun exposure.
- Reapply at least every 2 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 take other sun protection measures including:- -
- 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, C12-15 Alkyl Ethylhexanoate, Glycerin, Butylene Glycol, Silica, Thermus Thermophillus Ferment, Lactic Acid, Potassium Cetyl Phosphate, Cetearyl Alcohol, Betaine, Glyceryl Stearate SE, Magnesium Aluminum Silicate, PEG-100 Stearate, Saccharomyces Cerevisiae Extract, Rhodiola Rosea Root Extract, Citrus Aurantium Amara (Bitter Orange) Flower Extract, Bisabolol, Allantoin, Sodium PCA, Tocopheryl Acetate, Xanthan Gum, Dimethicone, Triethoxycaprylylsilane, Tocopherol, Ceteareth-20, Sodium Hydroxide, Silica Dimethyl Silylate, Tetrasodium Glutamate Diacetate, Salicylic Acid, Potassium Sorbate, Ethylhexylglycerin, Benzyl Alcohol, Linalool, Limonene, Mica, Phenoxyethanol, Iron Oxides (CI 77492, CI 77491).
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 15 mL Tube Carton
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INGREDIENTS AND APPEARANCE
TOTAL EYE CARE SPF 15
titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68479-608 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) C12-15 Alkyl Ethylhexanoate (UNII: GQJ580CH83) Glycerin (UNII: PDC6A3C0OX) Butylene Glycol (UNII: 3XUS85K0RA) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) THERMUS THERMOPHILUS LYSATE (UNII: 775R692494) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) Potassium Cetyl Phosphate (UNII: 03KCY6P7UT) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) Betaine (UNII: 3SCV180C9W) Glyceryl Stearate SE (UNII: FCZ5MH785I) Magnesium Aluminum Silicate (UNII: 6M3P64V0NC) PEG-100 Stearate (UNII: YD01N1999R) SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN) LEVOMENOL (UNII: 24WE03BX2T) Allantoin (UNII: 344S277G0Z) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Xanthan Gum (UNII: TTV12P4NEE) Dimethicone (UNII: 92RU3N3Y1O) Triethoxycaprylylsilane (UNII: LDC331P08E) Tocopherol (UNII: R0ZB2556P8) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) Sodium Hydroxide (UNII: 55X04QC32I) Silica Dimethyl Silylate (UNII: EU2PSP0G0W) Tetrasodium Glutamate Diacetate (UNII: 5EHL50I4MY) Salicylic Acid (UNII: O414PZ4LPZ) Potassium Sorbate (UNII: 1VPU26JZZ4) Ethylhexylglycerin (UNII: 147D247K3P) LINALOOL, (+/-)- (UNII: D81QY6I88E) LIMONENE, (+)- (UNII: GFD7C86Q1W) Mica (UNII: V8A1AW0880) Phenoxyethanol (UNII: HIE492ZZ3T) FERROUS OXIDE (UNII: G7036X8B5H) Product Characteristics Color PINK Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68479-608-02 1 in 1 CARTON 03/01/2018 1 15 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:68479-608-01 4 mL in 1 TUBE; Type 0: Not a Combination Product 03/01/2018 3 NDC:68479-608-00 2 mL in 1 POUCH; Type 0: Not a Combination Product 03/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/01/2018 Labeler - Dermalogica, Inc. (177698560) Establishment Name Address ID/FEI Business Operations Thibiant 083913913 MANUFACTURE(68479-608) Establishment Name Address ID/FEI Business Operations Diamond Wipes 161104729 MANUFACTURE(68479-608)
