SPL v4
SPL
SPL Set ID 6aa6ad3f-2c52-4031-9e6c-7526c42de71d
Route
TOPICAL
Published
Effective Date 2023-12-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (0.38400 g) Zinc Oxide (0.19600 g)
Inactive Ingredients
Mica Polymethylsilsesquioxane (4.5 Microns) Squalane Water Silicon Dioxide Bismuth Oxychloride Stearic Acid Aluminum Hydroxide Ceramide 3 Cholesterol Phytosphingosine Phenoxyethanol Butylene Glycol Caprylyl Glycol Barium Sulfate Angelica Sinensis Root Hexamethylene Diisocyanate/trimethylol Hexyllactone Crosspolymer Potassium Sorbate Hexylene Glycol Tranexamic Acid Triethoxycaprylylsilane Trimyristin Hydrogenated Soybean Lecithin Honey Indian Frankincense Resveratrol Lecithin, Soybean Silver Ferric Oxide Red Ferric Oxide Yellow

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-04-19
Description

Titanium Dioxide 9.6% Zinc Oxide 4.9%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 9.6% Zinc Oxide 4.9%

Uses
  • Helps prevent sunburn

Warnings

For external use only

Directions
  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • 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 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: Ask a doctor

Do Not Use

on damaged or broken skin

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Mica, Polymetylsilsesquioxane, Squalane, Water, Silia, Bismuth Oxychloride, Stearic Acid, Aluminum Hydroxide, Ceramide 3, Cholesterol, Phytosphingosine, Phenoxyethanol, Butylene Glycol, Caprylyl Glycol, Barium Sulfate, Angelica Polymorpha Sinensis Root Extract, HDI/Trimethylol Hexyllactone Crosspolymer, Potassium Sorbate, Hexylene Glycol, Dimethylacrlamide/Acrylic Acid/Polystyrene Ethyl Methacrylate Copolymer, Tranexamic Acid, Triethoxycaprylylsilane, Peat Extract, Trimyristin, Hydrogenated Lecithin, Oligopeptide-10, Tetrapeptide-14, Honey Extrac, Boswellia Serrata Extract, Resveratrol Lecithin, Silver. May contain: Iron Oxides, Titanium Dioxide.

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor

if rash occurs

Drug Facts Active Ingredients

Titanium Dioxide 9.6%

Zinc Oxide 4.9%

Keep Out of Each of Children.

Keep out of reach of children.

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

Rodan + Fields Enhancements Light, Medium, Bronze Product Labels

escription for Change™

RODAN+FIELDS®

ENHANCEMENTS

Mineral Peptides

BROAD SPECTRUM SPF 20

RODAN+FIELDS®

DERMATOLOGISTS

4g/0.14 Oz.

Manufactured for Rodan and Fields, LLC 111 Maiden Lane, Suite 400 San Francisco CA 94108 Made in the USA Please Recycle

visit rodanand fields.com  QUESTIONS OR COMMENTS 1-888-995-5656

Light

ENPL004

08-03-0023

Medium

ENPM004

80-03-0024

Bronze

ENPB004

80-03-0025

res

Structured Label Content

Uses
  • Helps prevent sunburn

Purpose

Sunscreen

Warnings

For external use only

Directions
  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • 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 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: Ask a doctor

Do Not Use (Do not use)

on damaged or broken skin

Other Information (Other information)

Protect this product from excessive heat and direct sun.

Inactive Ingredients (Inactive ingredients)

Mica, Polymetylsilsesquioxane, Squalane, Water, Silia, Bismuth Oxychloride, Stearic Acid, Aluminum Hydroxide, Ceramide 3, Cholesterol, Phytosphingosine, Phenoxyethanol, Butylene Glycol, Caprylyl Glycol, Barium Sulfate, Angelica Polymorpha Sinensis Root Extract, HDI/Trimethylol Hexyllactone Crosspolymer, Potassium Sorbate, Hexylene Glycol, Dimethylacrlamide/Acrylic Acid/Polystyrene Ethyl Methacrylate Copolymer, Tranexamic Acid, Triethoxycaprylylsilane, Peat Extract, Trimyristin, Hydrogenated Lecithin, Oligopeptide-10, Tetrapeptide-14, Honey Extrac, Boswellia Serrata Extract, Resveratrol Lecithin, Silver. May contain: Iron Oxides, Titanium Dioxide.

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs

Drug Facts Active Ingredients (Drug Facts Active ingredients)

Titanium Dioxide 9.6%

Zinc Oxide 4.9%

Keep Out of Each of Children. (Keep out of each of children.)

Keep out of reach of children.

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

Rodan + Fields Enhancements Light, Medium, Bronze Product Labels (Rodan + Fields ENHANCEMENTS - Light, Medium, Bronze Product Labels)

escription for Change™

RODAN+FIELDS®

ENHANCEMENTS

Mineral Peptides

BROAD SPECTRUM SPF 20

RODAN+FIELDS®

DERMATOLOGISTS

4g/0.14 Oz.

Manufactured for Rodan and Fields, LLC 111 Maiden Lane, Suite 400 San Francisco CA 94108 Made in the USA Please Recycle

visit rodanand fields.com  QUESTIONS OR COMMENTS 1-888-995-5656

Light

ENPL004

08-03-0023

Medium

ENPM004

80-03-0024

Bronze

ENPB004

80-03-0025

res

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:32.725080 · Updated: 2026-03-14T23:02:09.430554