OTC Medication Information: UVA/UVB SPF 15 Rodan and Fields

UVA/UVB SPF 15 RODAN AND FIELDS- octinoxate and 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.

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

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Rodan and Fields

Soothe


50 mL/ 1.7 Fl. Oz.
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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 mL in 100 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 3.4 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
OCTYLDODECANOL
HYDROGENATED POLYDECENE (550 MW)
BUTYLENE GLYCOL
DIMETHICONE
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
ASTROCARYUM MURUMURU SEED BUTTER
CHAMOMILE FLOWER OIL
CANTALOUPE
SQUALENE
CHOLESTEROL
OLETH-3 PHOSPHATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:14222-2022-2 1 BOTTLE (BOTTLE) in 1 BOX contains a BOTTLE (14222-2022-1)
1 NDC:14222-2022-1 50 mL in 1 BOTTLE This package is contained within the BOX (14222-2022-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 06/03/2011
Labeler — Rodan & Fields LLC. (051659584)
Registrant — Cosmetic Enterprises Ltd. (017701475)
Establishment
Name Address ID/FEI Operations
Cosmetic Enterprises Ltd. 017701475 manufacture

Revised: 01/2012 Rodan & Fields LLC.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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