Personalized Day Moisturizer with SPF 50

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]

PERSONALIZED DAY MOISTURIZER WITH SPF 50- homosalate, octisalate, zinc oxide cream 
Proven Skincare

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Personalized Day Moisturizer with SPF 50

Drug Facts

Active Ingredients

Homosalate 10%

Octisalate 5%

Zinc Oxide 16.5%

Purpose

Sunscreen

Uses

• Helps Prevent Sunburn.
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin caner and early skin aging caused by sun. 

Warnings

• For external use ony.

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

Sun Protection Measures 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.

Inactive Ingredients

Water, C15-19 Alkane, Octyldodecyl Neopentanoate, Sorbitan Olivate, Glycerin, Hydrogenated Polyisobutene, Dimethicone, Polyglyceryl-6 Polyricinoleate, Glyceryl Behenate, Sodium Chloride, Phenoxyethanol, Triethoxycaprylylsilane, Polyglyceryl-2 Isostearate, Polyhydroxystearic acid, Disteardimonium Hectorite, Saccharide Isomerate, Polysilicone-11, Xanthan Gum, Tocopheryl Acetate, Ethylhexylglycerin, Sclerotium Gum, Lecithin, Disodium EDTA, Pullulan, Gossypium Hirsutum (Cotton) Extract, Sodium Hydroxide.

Other Information

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

Questions or Comments?

go to www.provenskincate.com

Package Labeling:

PERSONALIZED DAY MOISTURIZER WITH SPF 50 
homosalate, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73572-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	165 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
WATER (UNII: 059QF0KO0R)
C15-19 ALKANE (UNII: CI87N1IM01)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
SORBITAN OLIVATE (UNII: MDL271E3GR)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYGLYCERYL-2 ISOSTEARATE (UNII: 7B8OE71MQC)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
XANTHAN GUM (UNII: TTV12P4NEE)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PULLULAN (UNII: 8ZQ0AYU1TT)
COTTON FIBER (UNII: 70LDW53ROO)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73572-005-30	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/15/2021	12/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/15/2021	12/31/2022

Labeler - Proven Skincare (117370905)

Revised: 11/2023

Document Id: 09453cf7-4665-9f6c-e063-6394a90a6518

34390-5

Set id: bcaded26-d7d2-4b1c-a3da-0254f972b1c5

Version: 2

Effective Time: 20231103