PROVEN PERSONALIZED DAY MOISTURIZER WITH SPF 50- zinc oxide cream

Proven Personalized Day Moisturizer With SPF 50 by

Drug Labeling and Warnings

Proven 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 15%

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 the sun.

Warnings

For external use only

Do not use

• on damaged or broken skin

Stop use 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 reapply: after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours children under 6 months: Ask a doctor  Use water resistant sunscreen if swimming or sweating.

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

Allantoin, Bisabolol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylyl Glycol, Cetyl Alcohol, Dimethiconol/Propylsilsesquioxane/Silicate Crosspolymer, Disodium EDTA, Ethylhexyl Isononanoate, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hexylene Glycol, Lysolecithin, Octyldodecyl Neopentanoate, PEG-75 Stearate, Phenoxyethanol, Pullulan, Pyrus Malus (Apple) Fruit Extract, Sclerotium Gum, Silica, Squalane, Trilaureth-4 Phosphate, Water, Xanthan Gum

Other Information

protect this product from excessive heat and direct sun.

Questions or comments?

Call (650) 427-0836

Package Labeling:

INGREDIENTS AND APPEARANCE

PROVEN PERSONALIZED DAY MOISTURIZER WITH SPF 50 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73572-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	150 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PEG-75 STEARATE (UNII: OT38R0N74H)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PULLULAN (UNII: 8ZQ0AYU1TT)
APPLE (UNII: B423VGH5S9)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SQUALANE (UNII: GW89575KF9)
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73572-004-30	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/14/2021

Labeler - Proven Skincare (117370905)