PERSONALIZED DAY MOISTURIZER WITH SPF- 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

Zinc Oxide 12%

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 40 minutes of swimming or sweating Immediately after towel drying. 
• Children under 6 months of age: Ask a doctor.

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, 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

Other Information

• Protect this product from excessive heat and direct sun.

Package Labeling:

INGREDIENTS AND APPEARANCE

PERSONALIZED DAY MOISTURIZER WITH SPF 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73572-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	120 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ISODODECANE (UNII: A8289P68Y2)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PROPANEDIOL (UNII: 5965N8W85T)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
DIMETHICONE (UNII: 92RU3N3Y1O)
NIACINAMIDE (UNII: 25X51I8RD4)
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)
ALLANTOIN (UNII: 344S277G0Z)
LEVOMENOL (UNII: 24WE03BX2T)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73572-003-30	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)