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NDC 73572-0006-30 Personalized Day Moisturizer with SPF 30 90; 50; 100 mg/mL; mg/mL; mg/mL Details

Personalized Day Moisturizer with SPF 30 90; 50; 100 mg/mL; mg/mL; mg/mL

Personalized Day Moisturizer with SPF 30 is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Proven Skincare. The primary component is HOMOSALATE; OCTISALATE; ZINC OXIDE.

Product Information

NDC	73572-0006
Product ID	73572-006_d06d5a8f-df37-489b-e053-2995a90adb9a
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Personalized Day Moisturizer with SPF 30
Proprietary Name Suffix	n/a
Non-Proprietary Name	HOMOSALATE, OCTISALATE, ZINC OXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	90; 50; 100
Active Ingredient Units	mg/mL; mg/mL; mg/mL
Substance Name	HOMOSALATE; OCTISALATE; ZINC OXIDE
Labeler Name	Proven Skincare
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2022-12-31

Package

Package Images

NDC 73572-0006-30 (73572000630)

Pricing Information	N/A
NDC Package Code	73572-006-30
Billing NDC	73572000630
Package	30 mL in 1 BOTTLE (73572-006-30)
Marketing Start Date	2021-11-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 00e3968e-a81d-4546-8004-ac11f75186ba Details

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, Dimethicone, Euphorbia Cerifera (Candelilla) Wax, PEG-10 Dimethicone, Caprylic/Capric Triglyceride, Sodium Chloride, Phenoxyethanol, Polyhydroxystearic Acid, Triethoxycaprylylsilane, Saccharide Isomerate, Ethylhexylglycerin, Tocopheryl Acetate, Glycerin, Disodium EDTA,

Xanthan Gum, Gossypium Hirsutum (Cotton) Extract.

Other Information

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

Questions or Comments?

go to www.provenskincate.com

Package Labeling:

INGREDIENTS AND APPEARANCE

PERSONALIZED DAY MOISTURIZER WITH SPF 30

homosalate, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73572-006
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	90 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	100 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CANDELILLA WAX (UNII: WL0328HX19)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
XANTHAN GUM (UNII: TTV12P4NEE)
COTTON FIBER (UNII: 70LDW53ROO)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73572-006-30	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/15/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/15/2021

Labeler - Proven Skincare (117370905)

Revised: 11/2021

Document Id: d06d5a8f-df37-489b-e053-2995a90adb9a

Set id: 00e3968e-a81d-4546-8004-ac11f75186ba

Version: 1

Effective Time: 20211110