UVA/UVB SPF 15  RODAN AND FIELDS- octinoxate, zinc oxide lotion 
Rodan & Fields 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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UVA and UVB SPF 15 Sunscreen

Active Ingredients          Purpose

Octinoxate 7.5%            Sunscreen

Zinc Oxide 3.4%            Sunscreen


Uses

Helps prevent sunburn
Higher SPF gives more sun protection
Temporarily protects chapped or cracked skin.

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

when using this product keep out of eyes. Rinse with water to remove.

Directions

Apply a generous dime-sized amount evenly over entire face every morning

Children under 6 months of age: ask a doctor.

Reapply as needed or after towel drying, swimming, or sweating.

Water, Octyldodecanol, Hydrogenated polydecene, butylene glycol, dimethicone, sodium dihydroxycetyl phosphate, glyceryl stearate, PEG-100 stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, astrocaryum murumuru butter, Chamomilla recutita (matricaria) flower oil, Cucumis melo (melon) fruit extract, Persea Gratissima (avacado) oil, Cholesterol/Potassium sulfate, Acetyl glucosamine, squalene, Cholesterol, Linoleic acid, Bisabolol, Tocopheryl Acetate, Oleth-3 phosphate, propylene glycol dicaprylate ethylhexylglycerin, caprylyl glycol, triethoxycaprylylsilane, polysorbate 60, boron nitride, xanthan gum, tetrasodium EDTA, citric acid, potassium sorbate, phenoxyethanol



image of box label


Rodan and Fields

Soothe


UVA/UVB SPF 15 Sunscreen


50 mL/ 1.7 Fl. Oz.



image of bottle





UVA/UVB SPF 15   RODAN AND FIELDS
octinoxate, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14222-2022
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.4 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
CANTALOUPE (UNII: 8QF5D5H6UH)  
SQUALENE (UNII: 7QWM220FJH)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14222-2022-21 in 1 BOX
1NDC:14222-2022-150 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/03/2011
Labeler - Rodan & Fields LLC. (051659584)
Registrant - Cosmetic Enterprises Ltd. (017701475)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Enterprises Ltd.017701475manufacture

Revised: 1/2012
Document Id: 44be628e-fe1d-4061-a3b2-5f1b72fb383b
Set id: 016102bc-c0cd-485e-8cad-91c08a770fdb
Version: 3
Effective Time: 20120124
 
Rodan & Fields LLC.