Personalized Day Moisturizer With Spf 50

Personalized Day Moisturizer With Spf 50
SPL v2
SPL
SPL Set ID bb921e91-9faf-4210-9091-ab511af9012a
Route
TOPICAL
Published
Effective Date 2022-02-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (120 mg)
Inactive Ingredients
Water Medium-chain Triglycerides Isoamyl Laurate Squalane Butyloctyl Salicylate Glycerin Methylpropanediol Cetyl Alcohol Glyceryl Monostearate Silicon Dioxide Polyglyceryl-2 Dipolyhydroxystearate Peg-75 Stearate Caprylyl Glycol Allantoin Apple Betasizofiran Phenylpropanol Pullulan Xanthan Gum Ceteth-20 Steareth-20 Aloe Vera Leaf Levomenol Tetrasodium Glutamate Diacetate Phenoxyethanol Ethylhexylglycerin Hexylene Glycol Tocopherol Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-01

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 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 • Use a water resistant sunscreen if swimming or sweating • Reapply at least every 2 hours • Children under 6 months of age: Ask a doctor

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 sleeved shirts, pants, hats, and sunglasses. Sun Protection Measures

Do Not Use
  • on damaged or broken skin
Other Information

• Protect the product in this container from excessive heat and direct sun.

Package Labeling:

Active Ingredients

Zinc Oxide 12%

Inactive Ingredients

• Water, Caprylic/Capric Triglyceride, Isoamyl Laurate, Squalane, Butyloctyl Salicylate, Jojoba Esters, Glycerin, Methylpropanediol, Cetyl Alcohol, Glyceryl Stearate, Silica, Polyglyceryl-2 Dipolyhydroxystearate, PEG-75 Stearate, Caprylyl Glycol, Allantoin, Fragrance, Pyrus Malus (Apple) Fruit Extract, Lysolecithin, Sclerotium Gum, Lecithin, Phenylpropanol, Pullulan, Xanthan Gum, Ceteth-20, Steareth-20, Aloe Barbadensis Leaf Juice Powder, Bisabolol, Tetrasodium Glutamate Diacetate, Phenoxyethanol, Ethylhexylglycerin, Hexylene Glycol, Tocopherol, Sodium Hydroxide

Questions Or Comments?

go to www.provenskincare.com Made in USA from local and imported materials Manufactured for PROVEN, Miami, FL, 33131



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 • Use a water resistant sunscreen if swimming or sweating • Reapply at least every 2 hours • Children under 6 months of age: Ask a doctor

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 sleeved shirts, pants, hats, and sunglasses. Sun Protection Measures

Do Not Use (Do not use)
  • on damaged or broken skin
Other Information

• Protect the product in this container from excessive heat and direct sun.

Package Labeling:

Active Ingredients

Zinc Oxide 12%

Inactive Ingredients

• Water, Caprylic/Capric Triglyceride, Isoamyl Laurate, Squalane, Butyloctyl Salicylate, Jojoba Esters, Glycerin, Methylpropanediol, Cetyl Alcohol, Glyceryl Stearate, Silica, Polyglyceryl-2 Dipolyhydroxystearate, PEG-75 Stearate, Caprylyl Glycol, Allantoin, Fragrance, Pyrus Malus (Apple) Fruit Extract, Lysolecithin, Sclerotium Gum, Lecithin, Phenylpropanol, Pullulan, Xanthan Gum, Ceteth-20, Steareth-20, Aloe Barbadensis Leaf Juice Powder, Bisabolol, Tetrasodium Glutamate Diacetate, Phenoxyethanol, Ethylhexylglycerin, Hexylene Glycol, Tocopherol, Sodium Hydroxide

Questions Or Comments? (Questions or Comments?)

go to www.provenskincare.com Made in USA from local and imported materials Manufactured for PROVEN, Miami, FL, 33131



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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