MEANINGFUL BEAUTY CINDY CRAWFORD SKIN BRIGHTENING DECOLLETE AND NECK TREATMENT SPF 15- avobenzone, octinoxate, octisalate, and oxybenzone cream

Meaningful Beauty Cindy Crawford by

Drug Labeling and Warnings

Meaningful Beauty Cindy Crawford by is a Otc medication manufactured, distributed, or labeled by Guthy-Renker LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Fact Label

Active ingredient

Avobenzone 3.0%, Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 5.0%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early aging caused by the sun.

Warnings

For external use only.

Do not use on damage or broken skin.

When using this product 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.
• Use a water resistant sunscreen if swimming or sweating.
• Reapply at least every 2 hrs.
• children under 6 months, ask a doctor.
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer early aging. To 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

Inactive ingredients

Water, Neopentyl Glycol Diheptanoate, Dicaprylyl Carbonate, Cetearyl Alcohol, Butylene Glycol, Glycerin, PEG-40 Stearate, PEG-100 Stearate, Glyceryl Stearate, Dimethicone, Cucumis Melo (Melon) Fruit Extract, Arctostaphylos Uva Ursi Leaf Extract, Ascorbyl Methylsilanol Pectinate, Magnesium Ascorbyl Phosphate, Tetrapeptide-21, Biosaccharide Gum-1, Dipotassium Glycyrrhizate, Caprylyl Glycol, Hydrogenated Vegetable Oil, Alcohol, Hydrogenated Lecithin, Hydrogenated Phosphatidylcholine, Cholesterol, Ethylhexylglycerin, Polysorbate 60, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Steareth-20, Disodium EDTA, Potassium Sorbate, Sodium Hydroxide, Chlorphenesin, Phenoxyethanol, Fragrance.

Questions or comments?

Within US 1-800-927-0047

SPL UNCLASSIFIED SECTION

Distributed by: Meaningful Beauty®
100 N. Sepulveda Blvd., El Segundo, CA 90245

PRINCIPAL DISPLAY PANEL - 120 mL Tube Label

Meaningful Beauty® Cindy Crawford

Skin Brightening Décolleté and Neck Treatment Broad Spectrum Sunscreen SPF 15

120 mL/4 FL OZ

INGREDIENTS AND APPEARANCE

MEANINGFUL BEAUTY CINDY CRAWFORD   SKIN BRIGHTENING DECOLLETE AND NECK TREATMENT SPF 15
avobenzone, octinoxate, octisalate, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70605-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mg  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mg  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-40 STEARATE (UNII: ECU18C66Q7)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONE (UNII: 92RU3N3Y1O)
MUSKMELON (UNII: ZV095H5633)
ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
TETRAPEPTIDE-21 (UNII: 179JUC43HU)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALCOHOL (UNII: 3K9958V90M)
CHOLESTEROL (UNII: 97C5T2UQ7J)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYSORBATE 60 (UNII: CAL22UVI4M)
STEARETH-20 (UNII: L0Q8IK9E08)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CHLORPHENESIN (UNII: I670DAL4SZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70605-006-53	1 in 1 BOX	04/30/2016	02/28/2017
1		50 mL in 1 JAR; Type 0: Not a Combination Product
2	NDC: 70605-006-57	50 mL in 1 TUBE; Type 0: Not a Combination Product	04/30/2016
3	NDC: 70605-006-89	20 mL in 1 TUBE; Type 0: Not a Combination Product	04/30/2016
4	NDC: 70605-006-41	120 mL in 1 TUBE; Type 0: Not a Combination Product	03/03/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	04/30/2016

Labeler - Guthy-Renker LLC (948861877)