Label: PERFECT TRUTH CC BROAD SPECTRUM SPF 30 OLE HENRIKSEN- avobenzone, homosalate, octinoxate, octisalate, octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51770-111-01, 51770-111-02 - Packager: Ole Henriksen
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 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% SunscreenOctinoxate 7.5% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 1.86% Sunscreen
Uses
Helps prevent sunburn.
Keep out of reach of children. If 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.
Directions
■Apply liberally and evenly 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 a Broad
Spectrum SPF value of 15 or higher and other sun protection measures including:
■ Limit time in the sun, especially from 10a.m.- 2 p.m.
■ Wear long-sleeved shirts, pants, hats, and sunglasses.
■ Reapply at least every 2 hours.
■ Use a water resistant sunscreen if swimming or sweating.
■ Children under 6 months of age: ask doctor.
Inactive ingredients
Water (Aqua/Eau), Titanium Dioxide, C12-15 Alkyl Benzoate, Steareth-21, Glycerin, Glyceryl Stearate, Propanediol, Caprylic/Capric Triglyceride, Polymethylsilsesquioxane, Dimethicone, Lauryl Phenylpropyl Methicone, Caprylyl Methicone, Cetearyl Alcohol, PPG-12/SMDI Copolymer, Iron Oxides, Triheptanoin, Mica, Fragrance, PEG-100 Stearate, Phenoxyethanol, Glycine Soja (Soybean) Seed Extract, Limonene, Cyclopentasiloxane, Caprylyl Glycol, Diethylhexyl Syringylidenemalonate, Aminomethyl Propanol, Vaccinium Myrtillus Fruit Extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Dimethicone Copolymer, Ethylhexylglycerin, Trisodium Ethylenediamine Disuccinate, Ferulic Acid, Laminaria Ochroleuca Extract, Tocopheryl Acetate, Saccharum Officinarum (Sugar Cane) Extract, Hexylene Glycol, Triethoxycaprylylsilane, Tin Oxide, Flavor, Sodium Citrate, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Medica Limonum (Lemon) Fruit Extract, Citrus Aurantium Dulcis (Orange) Flower Extract, Rosa Canina Seed Extract, Hydrolyzed Viola Tricolor Extract, Citrus Grandis (Grapefruit) Fruit Extract, Linalool, Acer Saccharum (Sugar Maple) Extract, Sodium Hyaluronate, Ceramide 2, Citral, Butylene Glycol, Benzyl Benzoate, Palmitoyl Tripeptide-5, Benzyl Alcohol, 3-O-Ethyl Ascorbic Acid, Tetrahexyldecyl Ascorbate, Camellia Sinensis Leaf Extract.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PERFECT TRUTH CC BROAD SPECTRUM SPF 30 OLE HENRIKSEN
avobenzone, homosalate, octinoxate, octisalate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51770-111 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 OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 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) C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ) STEARETH-21 (UNII: 53J3F32P58) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PROPANEDIOL (UNII: 5965N8W85T) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) DIMETHICONE (UNII: 92RU3N3Y1O) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TRIHEPTANOIN (UNII: 2P6O7CFW5K) MICA (UNII: V8A1AW0880) PEG-100 STEARATE (UNII: YD01N1999R) PHENOXYETHANOL (UNII: HIE492ZZ3T) SOYBEAN (UNII: L7HT8F1ZOD) LIMONENE, (+)- (UNII: GFD7C86Q1W) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CAPRYLYL GLYCOL (UNII: 00YIU5438U) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ) BILBERRY (UNII: 9P2U39H18W) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) FERULIC ACID (UNII: AVM951ZWST) LAMINARIA OCHROLEUCA (UNII: 4R2124HE76) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SUGARCANE (UNII: 81H2R5AOH3) HEXYLENE GLYCOL (UNII: KEH0A3F75J) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) STANNIC OXIDE (UNII: KM7N50LOS6) SODIUM CITRATE (UNII: 1Q73Q2JULR) ORANGE (UNII: 5EVU04N5QU) LEMON (UNII: 24RS0A988O) CITRUS SINENSIS FLOWER (UNII: H02N5LQ5F6) ROSA CANINA SEED (UNII: 4503R1M9UT) PUMMELO (UNII: ET1TN5W71X) LINALOOL, (+)- (UNII: F4VNO44C09) ACER SACCHARUM BARK/SAP (UNII: Z120VL0KAC) HYALURONATE SODIUM (UNII: YSE9PPT4TH) CERAMIDE 2 (UNII: C04977SRJ5) CITRAL (UNII: T7EU0O9VPP) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) BENZYL BENZOATE (UNII: N863NB338G) PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO) BENZYL ALCOHOL (UNII: LKG8494WBH) 3-O-ETHYL ASCORBIC ACID (UNII: 6MW60CB71P) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) GREEN TEA LEAF (UNII: W2ZU1RY8B0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51770-111-02 1 in 1 CARTON 1 NDC:51770-111-01 30 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(51770-111)
