Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID b7401ff8-ca47-4c74-813c-99c5f28c0b6d
Route
TOPICAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (0.032 g) Zinc Oxide (0.077 g)
Inactive Ingredients
Isododecane Cyclomethicone 5 Borosilicate Glass Butyloctyl Salicylate Hydrogenated Jojoba Oil/jojoba Oil, Randomized (iodine Value 64-70) Dimethicone Glycerin Water Hexyl Laurate Propanediol Polyglyceryl-4 Isostearate Butylene Glycol Stearic Acid Aluminum Oxide Zinc Pidolate Sclareolide Carnosine Silicon Dioxide Lowbush Blueberry Phenoxyethanol Linalool, (+/-)- Biosaccharide Gum-4 Ferric Oxide Red Dipropylene Glycol .alpha.-hexylcinnamaldehyde Limonene, (+)- Sodium Citrate, Unspecified Form Cetyl Peg/ppg-10/1 Dimethicone (hlb 3) Tocopherol Isopropyl Titanium Triisostearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2019-09-20 Until 2028-06-29

Description

Titanium Dioxide 3.2% Zinc Oxide 7.7%

Purpose

Sunscreen Sunscreen


Medication Information

Purpose

Sunscreen

Sunscreen

Description

Titanium Dioxide 3.2% Zinc Oxide 7.7%

Uses
  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.
Section 50566-9
  • Stop use and ask a doctor if rash occurs.
Section 50567-7
  • When using this product keep out of eyes. Rinse with water to remove.
Section 50570-1
  • Do not use on damaged or broken skin.
Warnings
  • For external use only
Questions

1-888-995-5656

Directions
  • After moisturizing, apply generously at least 15 minutes before sun exposure using fingertips. Smooth and blend evenly over entire face in an outward direction.
  • Wear alone or under makeup to prime skin.
  • Reapply at least every 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating.
  • Children under 6 months of age: ask a doctor.
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10 a.m.-2 p.m.
    • Wear long-sleeve shirts, pants, hats and sunglasses.
Active Ingredient

Titanium Dioxide 3.2%

Zinc Oxide 7.7%

Other Information

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Isododecane, Cyclopentasiloxane, Dimethicone Crosspolymer, Calcium Sodium Borosilicate, Butyloctyl Salicylate, Jojoba Esters, Dimethicone, Glycerin, Sea Water/Maris Aqua/Eau De Mer, Hexyl Laurate, Acrylates/Dimethicone Copolymer, Water, Vaccinium Angustifolium (Blueberry) Fruit Extract, Carnosine, Sclareolide, Zinc PCA, Fragrance/Parfum, Silica, Dimethicone/Polyglycerin-3 Crosspolymer, Polyglyceryl-4 Isostearate, PEG-10 Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Stearic Acid, Biosaccharide Gum-4, Methyl Carboxymethylphenyl Aminocarboxypropylphosphonate, Isopropyl Titanium Triisostearate, Tocopherol, Sodium Citrate, Butylene Glycol, Propanediol, Dipropylene Glycol, Phenoxyethanol, Hexyl Cinnamal, Limonene, Linalool, Alumina, Iron Oxides (Cl 77499).

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Principal Display Panel Carton Label

RODAN + FIELDS

RECHARGE

Regimen for Balancing, Boosting and Defending

Healthy-Looking Skin

Based on Multi-Med Therapy, RECHARGE is a multitasking skincare system that acts like a nutrient-rich super vitamin to balance and boost skin's defenses — visibly improving skin with the first use. Each step is clinically tested so they work together to defend against premature aging and repair skin's moisture barrier.

This 3-step Regimen was developed by Stanford-trained Dermatologists Dr. Katie Rodan and Dr. Kathy Fields.

RDDAN + FIELDS

3-in-1 Super Cleanser

125 mL / 4.2 Fl. Oz. U.S.

Ultra Boost

Moisturizing Treatment

50 mL / 1.7 FI. Oz. U.S.

Protect + Blur

Broad Spectrum SPF 30 Sunscreen

40 mL / 1.35 FI. Oz. U.S.


Structured Label Content

Uses
  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.
Section 50566-9 (50566-9)
  • Stop use and ask a doctor if rash occurs.
Section 50567-7 (50567-7)
  • When using this product keep out of eyes. Rinse with water to remove.
Section 50570-1 (50570-1)
  • Do not use on damaged or broken skin.
Purpose

Sunscreen

Sunscreen

Warnings
  • For external use only
Questions

1-888-995-5656

Directions
  • After moisturizing, apply generously at least 15 minutes before sun exposure using fingertips. Smooth and blend evenly over entire face in an outward direction.
  • Wear alone or under makeup to prime skin.
  • Reapply at least every 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating.
  • Children under 6 months of age: ask a doctor.
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10 a.m.-2 p.m.
    • Wear long-sleeve shirts, pants, hats and sunglasses.
Active Ingredient

Titanium Dioxide 3.2%

Zinc Oxide 7.7%

Other Information

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Isododecane, Cyclopentasiloxane, Dimethicone Crosspolymer, Calcium Sodium Borosilicate, Butyloctyl Salicylate, Jojoba Esters, Dimethicone, Glycerin, Sea Water/Maris Aqua/Eau De Mer, Hexyl Laurate, Acrylates/Dimethicone Copolymer, Water, Vaccinium Angustifolium (Blueberry) Fruit Extract, Carnosine, Sclareolide, Zinc PCA, Fragrance/Parfum, Silica, Dimethicone/Polyglycerin-3 Crosspolymer, Polyglyceryl-4 Isostearate, PEG-10 Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Stearic Acid, Biosaccharide Gum-4, Methyl Carboxymethylphenyl Aminocarboxypropylphosphonate, Isopropyl Titanium Triisostearate, Tocopherol, Sodium Citrate, Butylene Glycol, Propanediol, Dipropylene Glycol, Phenoxyethanol, Hexyl Cinnamal, Limonene, Linalool, Alumina, Iron Oxides (Cl 77499).

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.

Principal Display Panel Carton Label (Principal Display Panel - Carton Label)

RODAN + FIELDS

RECHARGE

Regimen for Balancing, Boosting and Defending

Healthy-Looking Skin

Based on Multi-Med Therapy, RECHARGE is a multitasking skincare system that acts like a nutrient-rich super vitamin to balance and boost skin's defenses — visibly improving skin with the first use. Each step is clinically tested so they work together to defend against premature aging and repair skin's moisture barrier.

This 3-step Regimen was developed by Stanford-trained Dermatologists Dr. Katie Rodan and Dr. Kathy Fields.

RDDAN + FIELDS

3-in-1 Super Cleanser

125 mL / 4.2 Fl. Oz. U.S.

Ultra Boost

Moisturizing Treatment

50 mL / 1.7 FI. Oz. U.S.

Protect + Blur

Broad Spectrum SPF 30 Sunscreen

40 mL / 1.35 FI. Oz. U.S.


Advanced Ingredient Data


Raw Label Data

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