Personalized Day Moisturizer With Spf (40)

Personalized Day Moisturizer With Spf (40)
SPL v2
SPL
SPL Set ID 3b6546ed-22ee-48e6-83cc-5cbadf567499
Route
TOPICAL
Published
Effective Date 2020-01-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (20 mg) Zinc Cation (10 mg)
Inactive Ingredients
Water Butyloctyl Salicylate Ethylhexyl Isononanoate Polyester-7 Glycerin Neopentyl Glycol Diheptanoate Cetyl Alcohol Glyceryl Monostearate Squalane Phenoxyethanol Peg-75 Stearate Apple Alkyl (c12-15) Benzoate Lysophosphatidylcholine, Soybean Betasizofiran Allantoin Ceteth-20 Steareth-20 Caprylyl Glycol Triceteareth-4 Phosphate Pullulan Xanthan Gum Hyaluronate Sodium Dimethiconol/propylsilsesquioxane/silicate Crosspolymer (450000000 Mw) Edetate Disodium Anhydrous Trilaureth-4 Phosphate Ethylhexylglycerin Hexylene Glycol Dicrateria Rotunda Oil Ruttnera Lamellosa Oil Silicon Dioxide Oat Green Tea Leaf Sodium Ascorbate Potassium Sorbate Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-03-01
Description

Titanium Dioxide 2% Zinc Oxide 1%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 2% Zinc Oxide 1%

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 sun.
Warnings

For external use only.

Directions
  • Apply liberally 15 minutes before sun exposure. Works best on moisturized skin. 
  • Reapply: 
  • After swimming or sweating Immediately after towel drying.
  • Children under 6 months of age: Ask a doctor. Use water resistant sunscreen if swimming or sweating.
  • Limit time in the sun, especially from 10 a.m. – 2 p.m.
  • Wear long sleeved shirts, pants, hats, and sunglasses.

Spending time in the sun increases your risk of skin cancer and early skin ageing. To decrease this risk, regularly use a sunscreen with a Broad- Spectrum SPF value of 15 or  higher and other sun protection measures including: Sun Protection Measures

Do Not Use

on damaged or broken skin.

Other Information
  • Protect this product from excessive heat and direct sun.
Package Labeling:

Active Ingredients

Titanium Dioxide 2%

Zinc Oxide 1%

Inactive Ingredients

Water (Aqua), Butyloctyl Salicylate, Octyldecyl Neopentanoate, Ethylhexyl Isononanoate, Polyester-7, Glycerin, Neopentyl Glycol Diheptanoate, Cetyl Alcohol, Glyceryl Stearate, Squalane, Phenoxyethanol, PEG-75 Stearate, Bisbolol, Hydrolyzed Sodium Hyaluronate, Pyrus Malus (Apple) Fruit Extract, C12-15 Alkyl Benzoate, Lysolecithin, Sclerotium Gum, Dimethiconol/Caprylylsilsesquioxane/ Silicate Crosspolymer, Allantoin, Ceteth-20, Steareth-20, Caprylyl Glycol, Triceteareth-4 Phosphate, Pullulan, Xanthan Gum, Sodium Hyaluronate,  Dimethiconol/Propylsilsesquioxane/Silicate Crosspolymer, Disodium EDTA, Trilaureth-4 Phosphate, Ethylhexylglycerin, Hexylene Glycol, Dicrateria Rotunda Oil, Ruttnera Lamellosa Oil, Lecithin, Silica, Avena Sativa (Oat) Kernel Extract, Camellia Sinensis Leaf Extract, Sodium  Ascorbate, Potassium Sorbate, Tocopherol.



When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Using and Ask A Doctor

if rash occurs.

Keep Out Of reach of Children.

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

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 sun.
Purpose

Sunscreen

Warnings

For external use only.

Directions
  • Apply liberally 15 minutes before sun exposure. Works best on moisturized skin. 
  • Reapply: 
  • After swimming or sweating Immediately after towel drying.
  • Children under 6 months of age: Ask a doctor. Use water resistant sunscreen if swimming or sweating.
  • Limit time in the sun, especially from 10 a.m. – 2 p.m.
  • Wear long sleeved shirts, pants, hats, and sunglasses.

Spending time in the sun increases your risk of skin cancer and early skin ageing. To decrease this risk, regularly use a sunscreen with a Broad- Spectrum SPF value of 15 or  higher and other sun protection measures including: Sun Protection Measures

Do Not Use (Do not use)

on damaged or broken skin.

Other Information
  • Protect this product from excessive heat and direct sun.
Package Labeling:

Active Ingredients

Titanium Dioxide 2%

Zinc Oxide 1%

Inactive Ingredients

Water (Aqua), Butyloctyl Salicylate, Octyldecyl Neopentanoate, Ethylhexyl Isononanoate, Polyester-7, Glycerin, Neopentyl Glycol Diheptanoate, Cetyl Alcohol, Glyceryl Stearate, Squalane, Phenoxyethanol, PEG-75 Stearate, Bisbolol, Hydrolyzed Sodium Hyaluronate, Pyrus Malus (Apple) Fruit Extract, C12-15 Alkyl Benzoate, Lysolecithin, Sclerotium Gum, Dimethiconol/Caprylylsilsesquioxane/ Silicate Crosspolymer, Allantoin, Ceteth-20, Steareth-20, Caprylyl Glycol, Triceteareth-4 Phosphate, Pullulan, Xanthan Gum, Sodium Hyaluronate,  Dimethiconol/Propylsilsesquioxane/Silicate Crosspolymer, Disodium EDTA, Trilaureth-4 Phosphate, Ethylhexylglycerin, Hexylene Glycol, Dicrateria Rotunda Oil, Ruttnera Lamellosa Oil, Lecithin, Silica, Avena Sativa (Oat) Kernel Extract, Camellia Sinensis Leaf Extract, Sodium  Ascorbate, Potassium Sorbate, Tocopherol.



When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Using and Ask A Doctor (Stop using and ask a doctor)

if rash occurs.

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.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:18.965398 · Updated: 2026-03-14T23:01:46.594887