SPL v4
SPL
SPL Set ID 2b3b6b62-364f-4aba-8024-3a73752b4c56
Route
TOPICAL
Published
Effective Date 2018-01-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (0.21000 g) Zinc Oxide (1.42500 g)
Inactive Ingredients
Water Cyclomethicone 5 Isododecane Pentylene Glycol Cetostearyl Alcohol Peg-10 Dimethicone (600 Cst) Butylene Glycol Polysorbate 60 Dimethicone Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Peg-100 Stearate Glyceryl Monostearate Caprylyl Glycol Squalane Citric Acid Monohydrate Xanthan Gum 1,2-hexanediol Peg-60 Almond Glycerides Ceteth-10 Phosphate Oleanolic Acid Masoprocol Glycerin Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Chlorphenesin Dihexadecyl Phosphate Cholesterol Hexyl Laurate Polyglyceryl-4 Isostearate Potassium Sorbate Sodium Benzoate Tocopherol Edetate Sodium Tetrahexyldecyl Ascorbate Azelaic Acid Stearic Acid Egg Phospholipids Aluminum Oxide Sodium Chondroitin Sulfate (porcine; 5500 Mw) Boerhavia Diffusa Root Methylisothiazolinone Tropolone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-03-05

Description

Titanium Dioxide 0.7% Zinc Oxide 4.75%

Purpose

Sunscreens


Medication Information

Purpose

Sunscreens

Description

Titanium Dioxide 0.7% Zinc Oxide 4.75%

Uses:

Helps prevent sunburn.

Purpose:

Sunscreens

Warnings:

For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with warm water to remove.

Directions:

Apply a generous dime-sized amount evenly over the entire face every morning, 15 minutes before sun exposure, as the final step in the Regimen. Reapply every 2 hours when exposed to the sun. Avoid the eye area.

Active Ingredients:

Titanium Dioxide 0.7%

Zinc Oxide 4.75%

Inactive Ingredients:

Water, Cyclopentasiloxane, Isododecane, Pentylene Glycol, Cetearyl Alcohol, Polysilicone-11, PEG-10 Dimethicone, Butylene Glycol, Polysorbate 60, Dimethicone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, PEG-100 Stearate, Glyceryl Stearate, Caprylyl Glycol, Squalane, Citric Acid, Xanthan Gum, 1,2-Hexanediol, PEG-60 Almond Glycerides, Ceteth-10 Phosphate, Oleanolic Acid, Nordihydroguaiaretic Acid, Glycerin, Carbomer, Chlorphenesin, Dimethiconol, Dicetyl Phosphate, Cholesterol, Hexyl Laurate, Fragrance, Polyglyceryl-4 Isostearate, Potassium Sorbate, Sodium Benzoate, Tocopherol, Disodium EDTA, Tetrahexyldecyl Ascorbate, Azelaic Acid, Stearic Acid, Lecithin, Alumina, Sodium Chondroitin Sulfate, Atelocollagen, Boerhavia Diffusa Root Extract, Methylisothiazolinone, Tropolone

Keep Out of Reach of Children:

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

Rodan and Fields Unblemished Label

RODAN and FIELDS UNBLEMISHED

4 Oil Control Lotion

BROAD SPECTRUM SPF 20 SUNSCREEN

Manufactured for Rodan and Fields, LLC

San Francisco, CA 94105

Made in USA  UNSS030  85-07-0015

Please recycle

visit rodanandfields.com

QUESTIONS OR COMMENTS

1-888-995-5656

30mL/1 Fl. Oz.


Structured Label Content

Uses: (USES:)

Helps prevent sunburn.

Purpose: (PURPOSE:)

Sunscreens

Warnings: (WARNINGS:)

For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with warm water to remove.

Directions: (DIRECTIONS:)

Apply a generous dime-sized amount evenly over the entire face every morning, 15 minutes before sun exposure, as the final step in the Regimen. Reapply every 2 hours when exposed to the sun. Avoid the eye area.

Active Ingredients: (ACTIVE INGREDIENTS:)

Titanium Dioxide 0.7%

Zinc Oxide 4.75%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Water, Cyclopentasiloxane, Isododecane, Pentylene Glycol, Cetearyl Alcohol, Polysilicone-11, PEG-10 Dimethicone, Butylene Glycol, Polysorbate 60, Dimethicone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, PEG-100 Stearate, Glyceryl Stearate, Caprylyl Glycol, Squalane, Citric Acid, Xanthan Gum, 1,2-Hexanediol, PEG-60 Almond Glycerides, Ceteth-10 Phosphate, Oleanolic Acid, Nordihydroguaiaretic Acid, Glycerin, Carbomer, Chlorphenesin, Dimethiconol, Dicetyl Phosphate, Cholesterol, Hexyl Laurate, Fragrance, Polyglyceryl-4 Isostearate, Potassium Sorbate, Sodium Benzoate, Tocopherol, Disodium EDTA, Tetrahexyldecyl Ascorbate, Azelaic Acid, Stearic Acid, Lecithin, Alumina, Sodium Chondroitin Sulfate, Atelocollagen, Boerhavia Diffusa Root Extract, Methylisothiazolinone, Tropolone

Keep Out of Reach of Children: (KEEP OUT OF REACH OF CHILDREN:)

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

Rodan and Fields Unblemished Label (RODAN and FIELDS UNBLEMISHED Label)

RODAN and FIELDS UNBLEMISHED

4 Oil Control Lotion

BROAD SPECTRUM SPF 20 SUNSCREEN

Manufactured for Rodan and Fields, LLC

San Francisco, CA 94105

Made in USA  UNSS030  85-07-0015

Please recycle

visit rodanandfields.com

QUESTIONS OR COMMENTS

1-888-995-5656

30mL/1 Fl. Oz.


Advanced Ingredient Data


Raw Label Data

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