UVA/UVB SPF 15 RODAN AND FIELDS (OCTINOXATE, ZINC OXIDE) LOTION [RODAN & FIELDS LLC.]

UVA/UVB SPF 15 RODAN AND FIELDS (OCTINOXATE, ZINC OXIDE) LOTION [RODAN & FIELDS LLC.]
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NDC	14222-2022-1, 14222-2022-2
Set ID	016102bc-c0cd-485e-8cad-91c08a770fdb
Category	HUMAN OTC DRUG LABEL
Packager	Rodan & Fields LLC.
Generic Name
Product Class
Product Number
Application Number	PART352

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ACTIVE INGREDIENT

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
PRINCIPAL DISPLAY PANEL

Rodan and Fields

Soothe

UVA/UVB SPF 15 Sunscreen

50 mL/ 1.7 Fl. Oz.

INGREDIENTS AND APPEARANCE

UVA/UVB SPF 15 RODAN AND FIELDS
octinoxate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14222-2022
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mL in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3.4 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14222-2022-2	1 in 1 BOX
1	NDC:14222-2022-1	50 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	06/03/2011

Labeler - Rodan & Fields LLC. (051659584)

Registrant - Cosmetic Enterprises Ltd. (017701475)

Name	Address	ID/FEI	Business Operations
Establishment
Cosmetic Enterprises Ltd.		017701475	manufacture

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