PERSONALIZED DAY MOISTURIZER WITH SPF- homosalate, octocrylene, zinc oxide cream

Personalized Day Moisturizer with SPF by

Drug Labeling and Warnings

Personalized Day Moisturizer with SPF by is a Otc medication manufactured, distributed, or labeled by Proven Skincare. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Homosalate 15%

Octocrylene 10%

Zinc Oxide 8%

Purpose

Sunscreen

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.

Do not use

on damaged or broken skin.

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.

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.

Sun Protection Measures 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:

• Limit time in the sun, especially from 10 a.m. – 2 p.m.
• Wear long sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients

Water, Avobenzone, Squalane, Cetearyl Alcohol, Ceteareth-20, C12-15 Alkyl Benzoate, CETEARETH-6 OLIVATE, Butyl Methoxydibenzoylmethane, Cyclopentasiloxane, Magnesium Ascorbyl Phosphate, Glycerin, Citrullus Lanatus (Watermelon) Fruit Extract (and) Citrulline (and) Glycerin (and) Aqua (and) Phenoxyethanol (and) Sodium Benzoate (and) Potassium Sorbate, Ceramide 3, Glutathione, Dimethicone, Hyaluronic acid, Pentylene Glycol, 1,3 Propanediol, Caprylyl Glycol, Ethlhexyl Glycerin, Panax Ginseng Extract, Calendula Officinalis Flower Extract, Ferulic acid, Xanthan Gum, Essential oils blend

Other Information

• Protect this product from excessive heat and direct sun.

Package Labeling:

INGREDIENTS AND APPEARANCE

PERSONALIZED DAY MOISTURIZER WITH SPF 
homosalate, octocrylene, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73572-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	80 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
AVOBENZONE (UNII: G63QQF2NOX)
SQUALANE (UNII: GW89575KF9)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETEARETH-6 OLIVATE (UNII: 8834VWF9MO)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
GLYCERIN (UNII: PDC6A3C0OX)
WATERMELON (UNII: 231473QB6R)
CITRULLINE (UNII: 29VT07BGDA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CERAMIDE 3 (UNII: 4370DF050B)
GLUTATHIONE (UNII: GAN16C9B8O)
DIMETHICONE (UNII: 92RU3N3Y1O)
HYALURONIC ACID (UNII: S270N0TRQY)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PROPANEDIOL (UNII: 5965N8W85T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
FERULIC ACID (UNII: AVM951ZWST)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73572-001-30	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/01/2020

Labeler - Proven Skincare (117370905)