MEANINGFUL BEAUTY CINDY CRAWFORD ANTIOXIDANT SPF 20 UVA/UVB- avobenzone, octinoxate, octisalate, and oxybenzone cream

Meaningful Beauty Cindy Crawford Antioxidant by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

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 skin aging caused by the sun.

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.
• use a water resistant sunscreen if swimming or sweating.
• reapply at least every 2 hours.
• 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 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

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

Other information

• protect this product from excessive heat and direct sun

Questions or comments?

Call toll free within the US 1-800-927-0047

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Label

Meaningful Beauty®
Cindy Crawford

Antioxidant Day Crème
Broad Spectrum SPF 20

.5 FL OZ/15mL

INGREDIENTS AND APPEARANCE

MEANINGFUL BEAUTY CINDY CRAWFORD ANTIOXIDANT   SPF 20 UVA/UVB
avobenzone, octinoxate, octisalate, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70605-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 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
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
CHOLESTEROL (UNII: 97C5T2UQ7J)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
STEARETH-20 (UNII: L0Q8IK9E08)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CHLORPHENESIN (UNII: I670DAL4SZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZYL BENZOATE (UNII: N863NB338G)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70605-004-12	30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/30/2016
2	NDC: 70605-004-06	15 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/30/2016

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)

Establishment
Name	Address	ID/FEI	Business Operations
Apex International LLC		015226132	MANUFACTURE(70605-004)