FDA.reportPublic FDA data

Fre Protect Me Lightweight Daily Moisturizer SPF 30

Manufacturer
Peer Pharm Ltd.
Effective date
2025-02-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:55:14

Label at a glance#

ProductFre Protect Me Lightweight Daily Moisturizer SPF 30
Active ingredientZINC 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 cancer and early skin aging caused by the sun.

Dosage and administration

• Shake well before use Apply liberally 15 minutes before sun exposure Reapply: After 40 minutes of swimming or sweating Immediately after towel drying At least every 2 hours 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 inclu...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 19.2%

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 cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

  • For external use only
  • Do not use on damaged or broken skin.
  • When using this product, Keep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctor if rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• Shake well before use

  • Apply liberally 15 minutes before sun exposure
  • Reapply:
  • After 40 minutes of swimming or sweating
  • Immediately after towel drying
  • At least every 2 hours
  • Sun Protection MeasuresSpending 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 10a.m. to 2p.m. 
  • Wear long-sleeve shirts, pants, hats, and sunglasses. 
  • Children under 6 months: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

Protect the product in this container from excessive heat and direct sun. Do not use if the seal is broken.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Coco-Caprylate, Glyceryl Oleate Citrate,Stearyl/Octyldodecyl Citrate Crosspolymer, Lauryl Glucoside,Xanthan Gum, Panthenol, Argania Spinosa Kernel Oil,Propanediol, Polyglyceryl-6 Laurate, Polyhydroxystearic Acid,Triethoxycaprylylsilane, Isomalt, Caprylic/Capric Triglyceride,Glycerin, Myristyl Glucoside, Caprylyl Glycol, Sodium Phytate,Lauroyl Lysine, Argania Spinosa Leaf Extract, Caprylhydroxamic Acid, Tocopherol, Citrus Aurantium Bergamia (Bergamot) FruitOil, Cymbopogon Flexuosus Oil, Lavandula Angustifolia(Lavender) Oil, Carnosine, Argania Spinosa Callus Culture Extract, Lecithin.

Questions or Comments

SPL UNCLASSIFIED SECTION

Call toll free 1-888-589-6243

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69435-1403-1Fre Protect Me Lightweight Daily Moisturizer SPF 301 in 1 CARTONCREAM13
69435-1403-1Fre Protect Me Lightweight Daily Moisturizer SPF 3050 mL in 1 TUBECREAM503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69435-1403FRE PROTECT ME LIGHTWEIGHT DAILY MOISTURIZER SPF 30 (ZINC OXIDE) CREAM [PEER PHARM LTD.]3Current NDC, 2 package rows20250215_8ee9f97b-9081-4e0c-aa7a-27a31cbee17a.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69435-140369435-1403-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
COCO-CAPRYLATE4828G836N6IACT
GLYCERYL MONOOLEATE CITRATENLE5KIG74KIACT
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMERPN88NW0KPKIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
XANTHAN GUMTTV12P4NEEIACT
PANTHENOLWV9CM0O67ZIACT
PROPANEDIOL5965N8W85TIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ISOMALTS870P55O2WIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERINPDC6A3C0OXIACT
MYRISTYL GLUCOSIDE6AK28695LFIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PHYTATE SODIUM88496G1ERLIACT
LAUROYL LYSINE113171Q70BIACT
ARGANIA SPINOSA LEAF51XV5WTF7EIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
TOCOPHEROLR0ZB2556P8IACT
BERGAMOT OIL39W1PKE3JIIACT
EAST INDIAN LEMONGRASS OILUP0M8M3VZWIACT
LAVENDER OILZBP1YXW0H8IACT
CARNOSINE8HO6PVN24WIACT
ARGAN OIL4V59G5UW9XIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
ZINC OXIDESOI2LOH54ZACTIB

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
Fre Protect Me Lightweight Daily Moisturizer SPF 30ZINC OXIDEPeer Pharm Ltd.8ee9f97b-9081-4e0c-aa7a-27a31cbee17a2025-02-13WarningsExact identifier
ndc (package): 69435-1403-1
ndc (product): 69435-1403
ndc11 (package): 69435140301
spl id: 2e02b978-09c4-de9b-e063-6294a90a45c3
spl set id: 8ee9f97b-9081-4e0c-aa7a-27a31cbee17a

Reported adverse events (FAERS/openFDA)#

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