Label: PERFECT TRUTH CC EYE BROAD SPECTRUM SPF 15 OLEHENRIKSEN- avobenzone, homosalate, octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51770-110-01, 51770-110-02 - Packager: Ole Henriksen
- Category: HUMAN OTC DRUG LABEL
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 March 27, 2013
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active Ingredients Purpose
Avobenzone 2% Sunscreen
Homosalate 5% Sunscreen
Octocrylene 1.86% Sunscreen
Uses
helps prevent sunburnKeep out of reach of children. If product is swallowed, get medical help or
contact a Poison Control Center right away.Stop use and ask a doctor if rash occurs
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 product is swallowed, get medical help or
contact a Poison Control Center right away.Directions
Apply liberally 15 minutes before sun exposure
Sun Protection Measures. Spending time in the sun increases your risk of skin
cancer and early skin aging. To decrease this risk, regularly use a sunscreen
with 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
Reapply at least every 2 hours
Use a water resistant sunscreen if swimming or sweating
Children under 6 months: Ask a doctorWater (Aqua/Eau), Titanium Dioxide, Caprylic/Capric Triglyceride, Propanediol, Cocoglycerides, Glyceryl Stearate, PEG-40 Stearate, Jojoba Esters, Glycerin, Isostearyl, Neopentanoate, Mica, Butyrospermum Parkii (Shea) Butter, Dimethicone, Phenethyl Benzoate, Beeswax, Dimethicone/Vinyl Dimethicone Crosspolymer, Iron Oxides, Cyclopentasiloxane, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Cetyl Phosphate, Isostearyl Hydroxystearate, Stearyl Alcohol, Phenoxyethanol, Cetearyl Alcohol, Tocopheryl Acetate, Acrylates/Dimethicone Copolymer, Imperata Cylindrica Root Extract, Caprylyl Glycol, Chlorphenesin, Silica.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PERFECT TRUTH CC EYE BROAD SPECTRUM SPF 15 OLEHENRIKSEN
avobenzone, homosalate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51770-110 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1.86 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PROPANEDIOL (UNII: 5965N8W85T) COCO-GLYCERIDES (UNII: ISE9I7DNUG) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-40 STEARATE (UNII: ECU18C66Q7) GLYCERIN (UNII: PDC6A3C0OX) ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q) MICA (UNII: V8A1AW0880) SHEA BUTTER (UNII: K49155WL9Y) DIMETHICONE (UNII: 92RU3N3Y1O) PHENETHYL BENZOATE (UNII: 0C143929GK) YELLOW WAX (UNII: 2ZA36H0S2V) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) CETYL PHOSPHATE (UNII: VT07D6X67O) ISOSTEARYL HYDROXYSTEARATE (UNII: F7540880P0) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) PHENOXYETHANOL (UNII: HIE492ZZ3T) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51770-110-02 1 in 1 CARTON 1 NDC:51770-110-01 7 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/27/2013 Labeler - Ole Henriksen (133369058) Registrant - Ole Henriksen (133369058) Establishment Name Address ID/FEI Business Operations Cosway Company, Inc. 620899877 manufacture(51770-110)