PERSONALIZED DAY MOISTURIZER WITH SPF 50- zinc oxide cream

Personalized Day Moisturizer with SPF 50 by

Drug Labeling and Warnings

Personalized Day Moisturizer with SPF 50 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

Stop using and ask a doctor

• if rash occurs.

When using this product

• keep out of eyes. Rinse with water to remove.

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  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

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

Other Information

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

Questions or Comments?

go to www.provenskincare.comMade in USA from local and imported materialsManufactured for PROVEN, Miami, FL, 33131

Package Labeling:

INGREDIENTS AND APPEARANCE

PERSONALIZED DAY MOISTURIZER WITH SPF 50 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73572-007
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)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
SQUALANE (UNII: GW89575KF9)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
PEG-75 STEARATE (UNII: OT38R0N74H)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALLANTOIN (UNII: 344S277G0Z)
APPLE (UNII: B423VGH5S9)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
PHENYLPROPANOL (UNII: 0F897O3O4M)
PULLULAN (UNII: 8ZQ0AYU1TT)
XANTHAN GUM (UNII: TTV12P4NEE)
CETETH-20 (UNII: I835H2IHHX)
STEARETH-20 (UNII: L0Q8IK9E08)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LEVOMENOL (UNII: 24WE03BX2T)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73572-007-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/01/2022

Labeler - Proven Skincare (117370905)