PERFECT TRUTH CC BROAD SPECTRUM SPF 30 OLE HENRIKSEN- avobenzone, homosalate, octinoxate, octisalate, octocrylene cream

Perfect Truth cc Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Perfect Truth cc Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Ole Henriksen, Cosway Company, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients      Purpose

Avobenzone 2%       Sunscreen   
Homosalate  5%       Sunscreen

Octinoxate 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

Ole Henriksen

all skin types/anti-aging

perfect truth cc creme

broad spectrum SPF 30 sunscreen

youth defending complexion corrector with 5 sources of vitamin C and ferulic acid

1 fl. oz./30 mL

INGREDIENTS AND APPEARANCE

PERFECT TRUTH CC BROAD SPECTRUM SPF 30  OLE HENRIKSEN
avobenzone, homosalate, octinoxate, octisalate, octocrylene cream

Product 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)