Drug Facts

Active Ingredients

Zinc Oxide 12%

Purpose

Sunscreen

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.

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.

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

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:

Label4

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73572-003-30	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	03/01/2020

Labeler - Proven Skincare (117370905)

Personalized Day Moisturizer with SPF (50)