FDA.reportPublic FDA data

Replenishing Daily Protection Non-Tinted

Manufacturer
SOLUTIONS SKIN CARE LLC | Custom Analytics LLC | Fragrance Manufacturing Inc. | Fallien Cosmeceuticals Ltd.
Effective date
2025-12-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:22:33

Label at a glance#

ProductReplenishing Daily Protection Non-Tinted
Active ingredientZINC OXIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 16%

OTC - PURPOSE SECTION

Sunscreen

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 SECTION

For external use only. Do not use on broken or damaged 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Use a water-resistant product if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: 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 INGREDIENT SECTION

Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Hydrogen Dimethicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer

OTHER SAFETY INFORMATION

  • Reef Friendly
  • No Animal Testing
  • 100% Free of: Chemical Sunscreens, Dyes, Parabens, Fragrances
  • Non-comedogenic

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87149-226-15Replenishing Daily Protection Non-Tinted1.5 g in 1 PACKETCREAM1.52

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87149-22687149-226-15
58892-226

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
DIMETHICONE92RU3N3Y1OIACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
ZINC OXIDESOI2LOH54ZACTIB
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
CYCLOHEXASILOXANEXHK3U310BAIACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CERAMIDE 34370DF050BIACT
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER9NH1UDD2RRIACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Replenishing Daily Protection Non-TintedZINC OXIDESOLUTIONS SKIN CARE LLC40332cf3-e4e5-0c00-e063-6394a90a683d2025-12-12WarningsExact identifier
ndc (package): 87149-226-15
ndc (product): 87149-226
ndc11 (package): 87149022615
spl id: 45c35a03-f96e-437d-e063-6394a90a0d82
spl set id: 40332cf3-e4e5-0c00-e063-6394a90a683d
Replenishing Daily Protection Non-TintedZINC OXIDESOLUTIONS SKIN CARE LLC4032913b-4bc3-6920-e063-6294a90a6e2d2025-12-12WarningsExact identifier
ndc (product): 87149-226
Proceuticals Private Label by TiZO non-tinted replenishing daily protectionZINC OXIDEFallien Cosmeceuticals, Ltd2203ea22-d12a-99fe-e063-6394a90aca9f2024-09-13WarningsExact identifier
ndc (product): 58892-226

Reported adverse events (FAERS/openFDA)#

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