MEANINGFUL BEAUTY CINDY CRAWFORD MAINTENANCE 1 DAILY MOISTURE SPF 8- octinoxate and avobenzone lotion 
Guthy-Renker LLC

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.

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Meaningful Beauty® Cindy Crawford Maintenance 1 Daily Moisture SPF 8

Drug Facts

Active Ingredient

Octinoxate5.0%
Avobenzone3.0%

Uses

helps prevent sunburn. Sunscreen gives more sunburn protection.

Warnings

For external use only. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation develops or lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Sun alert

Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Directions

Use in the morning and before sun exposure. Smooth onto face after cleansing. Children under 6 months of age: ask a doctor.

Inactive Ingredients

Water (Aqua), Glycerin, Ascorbyl Methylsilanol Pectinate, Propylene Glycol, Glyceryl Stearate, Acacia Senegal Extract, Achillea Millefolium Extract, Arctostaphylos Uva Ursi Leaf Extract, Cucumis Melo (Melon) Fruit Extract, Magnesium Ascorbyl Phosphate, Dipotassium Glycyrrhizate, Cholesterol, Lecithin, Hydrogenated Vegetable Oil, Caprylic/Capric Triglyceride, Sorbitol, Glycol Stearate, PEG-6 Stearate, PEG-32 Stearate, PEG-75 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol Denat., Sodium Sulfite, Sodium Bisulfite, BHT, Sodium Hydroxide, Disodium EDTA, Tetrasodium EDTA, Fragrance (Parfum), Benzyl Benzoate, Benzyl Salicylate, Citronellol, Benzoic Acid, Butylparaben, Chlorphenesin, Ethylparaben, Isobutylparaben, Methylparaben, Phenoxyethanol, Potassium Sorbate, Propylparaben, Sodium Methylparaben

Distributed by:
Guthy-Renker® (UK) Ltd.
Covent Garden,
London WC2E 8AA
0800 320 504

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Box

Meaningful Beauty®
Cindy Crawford

Maintenance 1

Daily Moisture
SPF 8 UVA/UVB

.5 FL OZ/15mL e

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Box
MEANINGFUL BEAUTY CINDY CRAWFORD MAINTENANCE 1 DAILY MOISTURE SPF 8 
octinoxate and avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70605-019
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 mg  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SORBITOL (UNII: 506T60A25R)  
GLYCOL STEARATE (UNII: 0324G66D0E)  
ALCOHOL (UNII: 3K9958V90M)  
SODIUM SULFITE (UNII: VTK01UQK3G)  
SODIUM BISULFITE (UNII: TZX5469Z6I)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
EDETATE SODIUM (UNII: MP1J8420LU)  
BENZYL BENZOATE (UNII: N863NB338G)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
ETHYLPARABEN (UNII: 14255EXE39)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70605-019-0615 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/30/2016
2NDC:70605-019-461 in 1 BOX04/30/2016
215 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
3NDC:70605-019-1230 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/30/2016
4NDC:70605-019-721 in 1 BOX04/30/2016
430 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35204/30/2016
Labeler - Guthy-Renker LLC (948861877)

Revised: 9/2016
Document Id: 37a52869-ce9f-4364-b661-a4e96e223807
Set id: 4e71c272-e214-49b6-b804-e70c2f6f5806
Version: 1
Effective Time: 20160901
 
Guthy-Renker LLC