FDA.reportPublic FDA data

Personalized Day Moisturizer with SPF 50

Manufacturer
Proven Skincare
Effective date
2021-11-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:27:57

Label at a glance#

ProductPersonalized Day Moisturizer with SPF 50
Active ingredientHOMOSALATE, OCTISALATE, ZINC OXIDE
Label structure8 sections

Indications and 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. 

Dosage and administration

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 ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 10%

Octisalate 5%

Zinc Oxide 16.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

  • For external use ony.

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin

Stop using and ask a doctor

OTC - STOP USE SECTION

  • if rash occurs.

When using this product

OTC - WHEN USING SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73572-00573572-005-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
C15-19 ALKANECI87N1IM01IACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
SORBITAN OLIVATEMDL271E3GRIACT
GLYCERINPDC6A3C0OXIACT
HYDROGENATED POLYBUTENE (1300 MW)7D1YQ9Y5EZIACT
DIMETHICONE92RU3N3Y1OIACT
POLYGLYCERYL-6 POLYRICINOLEATEYPM0ZOC2HRIACT
SODIUM CHLORIDE451W47IQ8XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
POLYGLYCERYL-2 ISOSTEARATE7B8OE71MQCIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
SACCHARIDE ISOMERATEW8K377W98IIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
XANTHAN GUMTTV12P4NEEIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
BETASIZOFIRAN2X51AD1X3TIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
PULLULAN8ZQ0AYU1TTIACT
COTTON FIBER70LDW53ROOIACT
SODIUM HYDROXIDE55X04QC32IIACT
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
09453cf7-4665-9f6c-e063-6394a90a6518bcaded26-d7d2-4b1c-a3da-0254f972b1c52023-11-03WarningsExact identifier
spl set id: bcaded26-d7d2-4b1c-a3da-0254f972b1c5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.