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

Description

Zinc Oxide 12%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 12%

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
Warnings

For external use only.

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

Do Not Use

on damaged or broken skin.

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

Active Ingredients

Zinc Oxide 12%

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

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 ), decreases the risk of skin cancer and early skin aging caused by sun. Directions
Purpose

Sunscreen

Warnings

For external use only.

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

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

Zinc Oxide 12%

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

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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