drug facts

drug facts
SPL v5
SPL
SPL Set ID c787e3b9-33b1-4c47-95bd-b14cf6558938
Route
topical
Published
Effective Date 2025-12-08
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 dimethicone crosspolymer calcium sodium borosilicate butyloctyl salicylate hydrogenated jojoba oil/jojoba oil, randomized (iodine value 64-70) dimethicone, unspecified glycerin sodium chloride hexyl laurate acrylic acid/dimethicone methacrylate/ethylhexyl acrylate copolymer propanediol water polyglyceryl-4 isostearate polyglyceryl-3 polydimethylsiloxyethyl dimethicone (4000 mpa.s) dimethicone peg-10 phosphate butylene glycol dimethicone/polyglycerin-3 crosspolymer triethoxysilylethyl polydimethylsiloxyethyl hexyl dimethicone stearic acid aluminum oxide zinc pidolate carnosine sclareolide silicon dioxide phenoxyethanol biosaccharide gum-4 ferric oxide red dipropylene glycol methyl carboxymethylphenyl aminocarboxypropylphosphonate sodium citrate, unspecified form cetyl peg/ppg-10/1 dimethicone (hlb 3) tocopherol isopropyl titanium triisostearate linalool, (+/-)- .alpha.-hexylcinnamaldehyde trimethylbenzenepropanol dimethyl benzyl carbinyl acetate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-11-14

Purpose

Sunscreen Sunscreen

Description

Titanium Dioxide 3.2% Zinc Oxide 7.7%


Medication Information

Warnings

For external use only.

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.
Purpose

Sunscreen

Sunscreen

Directions
  • After moisturizing, apply generously 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.
  • 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.
    • Children under 6 months of age: ask a doctor.
Other Information

Protect this product 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, Propanediol, Water/Aqua/Eau, Polyglyceryl-4 Isostearate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, PEG-10 Dimethicone, Fragrance/Parfum, Butylene Glycol, Dimethicone/ Polyglycerin-3 Crosspolymer, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Stearic Acid, Alumina, Zinc PCA, Carnosine, Sclareolide, Silica, Phenoxyethanol, Biosaccharide Gum-4, Iron Oxides (Cl 77491), Dipropylene Glycol, Methyl Carboxymethylphenyl Aminocarboxypropylphosphonate, Sodium Citrate, Cetyl PEG/PPG-10/1 Dimethicone, Tocopherol, Isopropyl Titanium Triisostearate, Linalool, Hexyl Cinnamal, Trimethylbenzenepropanol, Dimethyl Phenethyl Acetate.

Description

Titanium Dioxide 3.2% Zinc Oxide 7.7%

Questions?

1-888-995-5656

rodanandfields.com

Section 50565-1

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

Do Not Use
  • on damaged or broken skin
Active Ingredients

Titanium Dioxide 3.2%

Zinc Oxide 7.7%

When Using This Product
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If
  • rash occurs.
Principal Display Panel 40 Ml Carton Label

RODAN + FIELDS

RECHARGE

Protect + Blur

Broad Spectrum SPF 30 Sunscreen

3

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


Structured Label Content

Warnings

For external use only.

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.
Purpose

Sunscreen

Sunscreen

Directions
  • After moisturizing, apply generously 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.
  • 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.
    • Children under 6 months of age: ask a doctor.
Other Information

Protect this product 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, Propanediol, Water/Aqua/Eau, Polyglyceryl-4 Isostearate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, PEG-10 Dimethicone, Fragrance/Parfum, Butylene Glycol, Dimethicone/ Polyglycerin-3 Crosspolymer, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Stearic Acid, Alumina, Zinc PCA, Carnosine, Sclareolide, Silica, Phenoxyethanol, Biosaccharide Gum-4, Iron Oxides (Cl 77491), Dipropylene Glycol, Methyl Carboxymethylphenyl Aminocarboxypropylphosphonate, Sodium Citrate, Cetyl PEG/PPG-10/1 Dimethicone, Tocopherol, Isopropyl Titanium Triisostearate, Linalool, Hexyl Cinnamal, Trimethylbenzenepropanol, Dimethyl Phenethyl Acetate.

Questions?

1-888-995-5656

rodanandfields.com

Section 50565-1 (50565-1)

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

Do Not Use (Do not use)
  • on damaged or broken skin
Active Ingredients

Titanium Dioxide 3.2%

Zinc Oxide 7.7%

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rash occurs.
Principal Display Panel 40 Ml Carton Label (Principal Display Panel - 40 mL Carton Label)

RODAN + FIELDS

RECHARGE

Protect + Blur

Broad Spectrum SPF 30 Sunscreen

3

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


Advanced Ingredient Data


Raw Label Data

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