Label: SKINPERFECT PRIMER SPF 30- titanium dioxide and zinc oxide lotion
- NDC Code(s): 68479-130-00, 68479-130-02, 68479-130-04
- 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 5, 2017
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
-
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
-
Directions
- apply liberally 30 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
-
Inactive ingredients
Cyclopentasiloxane, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Diisopropyl Adipate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Silica, Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl, Dimethicone, Water/Aqua/Eau, Arginine/Lysine Polypeptide, Camellia Sinensis Leaf Extract, Palmitoyl Dipeptide-5, Diaminobutyroyl Hydroxythreonine, Palmitoyl Dipeptide-5 Diaminohydroxybutyrate, Sodium Hyaluronate, Hydrolyzed Soy Protein, Silanetriol, Hydrolyzed Pearl, Lavendula Spica (Lavender) Flower Oil, Lavandula Hybrida Oil, Eucalyptus Globulus Leaf Oil, Sodium PCA, Polyhydroxystearic Acid, Triethoxycaprylylsilane, Stearic Acid, Aluminum Hydroxide, PEG/PPG-18/18 Dimethicone, PEG/PPG-20/15 Dimethicone, Glycerin, Phenoxyethanol, Ethylhexylglycerin, Tin Oxide, Iron Oxides CI77491, CI77492, CI77499.
- Other information
- Questions or comments
- PRINCIPAL DISPLAY PANEL - 22 mL Tube Carton
-
INGREDIENTS AND APPEARANCE
SKINPERFECT PRIMER SPF 30
titanium dioxide and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68479-130 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 40 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 140 mg in 1 mL Inactive Ingredients Ingredient Name Strength Cyclomethicone 5 (UNII: 0THT5PCI0R) Diisopropyl Adipate (UNII: P7E6YFV72X) Medium-Chain Triglycerides (UNII: C9H2L21V7U) Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone (UNII: 25G622K2RA) Green Tea Leaf (UNII: W2ZU1RY8B0) Hyaluronate Sodium (UNII: YSE9PPT4TH) Calcium Carbonate (UNII: H0G9379FGK) Silanetriol (UNII: E52D0J3TS5) Lavender Oil (UNII: ZBP1YXW0H8) Lavandin Oil (UNII: 9RES347CKG) Eucalyptus Oil (UNII: 2R04ONI662) Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2) Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F) Triethoxycaprylylsilane (UNII: LDC331P08E) Aluminum Hydroxide (UNII: 5QB0T2IUN0) Stearic Acid (UNII: 4ELV7Z65AP) PEG/PPG-18/18 Dimethicone (UNII: 9H0AO7T794) PEG/PPG-20/15 Dimethicone (UNII: 06R6X77P9C) Glycerin (UNII: PDC6A3C0OX) Phenoxyethanol (UNII: HIE492ZZ3T) Ethylhexylglycerin (UNII: 147D247K3P) Stannic Oxide (UNII: KM7N50LOS6) Ferric Oxide Red (UNII: 1K09F3G675) Ferric Oxide Yellow (UNII: EX438O2MRT) Ferrosoferric Oxide (UNII: XM0M87F357) Product Characteristics Color PINK Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68479-130-02 1 in 1 CARTON 02/13/2012 1 22 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:68479-130-00 2 mL in 1 POUCH; Type 0: Not a Combination Product 02/13/2012 3 NDC:68479-130-04 50 mL in 1 POUCH; Type 0: Not a Combination Product 02/13/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 02/13/2012 Labeler - Dermalogica, Inc. (177698560) Establishment Name Address ID/FEI Business Operations McKenna 090631412 MANUFACTURE(68479-130) Establishment Name Address ID/FEI Business Operations Diamond Wipes 161104729 MANUFACTURE(68479-130)
