personalized day moisturizer with spf (50)

personalized day moisturizer with spf (50)
SPL v3
SPL
SPL Set ID f4d682bc-825f-494c-8528-3d328dc63994
Route
topical
Published
Effective Date 2020-01-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc cation (120 mg)
Inactive Ingredients
water alkyl (c12-15) benzoate butyloctyl salicylate isododecane polymethylsilsesquioxane (4.5 microns) octyldodecyl neopentanoate propanediol caprylyl trisiloxane dimethicone niacinamide trilaureth-4 phosphate allantoin levomenol tocopherol sodium chloride caprylyl glycol ethylhexylglycerin hexylene glycol phenoxyethanol tetrasodium glutamate diacetate polyethylene glycol 500 sodium hydroxide

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-03-01
Purpose

Sunscreen

Description

Zinc Oxide 12%

Medication Information

Warnings

For external use only.

Uses
  • Helps Prevent Sunburn. 
  • If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by sun. Directions
Purpose

Sunscreen

Directions
  • Apply liberally 15 minutes before sun exposure. Works best on moisturized skin. 
  • Reapply: 
  • After 40 minutes of swimming or sweating Immediately after towel drying. 
  • Children under 6 months of age: Ask a doctor.
  • 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

Other Information
  • Protect this product from excessive heat and direct sun.
Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Isododecane, Lauryl PEG-8 Dimethicone, Polymethylsilsesquioxane, Octyldodecyl Neopentanoate, Propanediol, Caprylyl Methicone, Dimethicone, Niacinamide, Dimethiconol/Propylsilsesquioxane/ Silicate Crosspolymer,Trilaureth-4 Phosphate, Allantoin, Bisabolol, Tocopherol, Sodium Chloride, Capryl Glycol, Ethylhexylglycerin, Hexylene Glycol, Phenoxyethanol, Tetrasodium Glutamate Diacetate, Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl Dimethicone, PEG-10, Sodium Hydroxide

Description

Zinc Oxide 12%

Do Not Use

on damaged or broken skin.

Package Labeling:

Active Ingredients

Zinc Oxide 12%

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

Warnings

For external use only.

Uses
  • Helps Prevent Sunburn. 
  • If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by sun. Directions
Purpose

Sunscreen

Directions
  • Apply liberally 15 minutes before sun exposure. Works best on moisturized skin. 
  • Reapply: 
  • After 40 minutes of swimming or sweating Immediately after towel drying. 
  • Children under 6 months of age: Ask a doctor.
  • 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

Other Information
  • Protect this product from excessive heat and direct sun.
Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Isododecane, Lauryl PEG-8 Dimethicone, Polymethylsilsesquioxane, Octyldodecyl Neopentanoate, Propanediol, Caprylyl Methicone, Dimethicone, Niacinamide, Dimethiconol/Propylsilsesquioxane/ Silicate Crosspolymer,Trilaureth-4 Phosphate, Allantoin, Bisabolol, Tocopherol, Sodium Chloride, Capryl Glycol, Ethylhexylglycerin, Hexylene Glycol, Phenoxyethanol, Tetrasodium Glutamate Diacetate, Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl Dimethicone, PEG-10, Sodium Hydroxide

Do Not Use (Do not use)

on damaged or broken skin.

Package Labeling:

Active Ingredients

Zinc Oxide 12%

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:19.871090 · Updated: 2026-03-14T23:01:48.065872