FDA.reportPublic FDA data

Usana Celavive Daily Mineral Protective Cream Moisturizer with Sunscreen SPF 30

Manufacturer
USANA Health Sciences, Inc.
Effective date
2023-10-19
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:57:03

Label at a glance#

ProductUsana Celavive Daily Mineral Protective Cream Moisturizer with Sunscreen SPF 30
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

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

Dosage and administration

Apply to forehead, cheeks, nose, chin, and neck as the last step in your daytime skincare routine. Apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. limit time in the sun, especially from 10 a.m.–2 p.m.  wear long-sleeved shirts, pants, hats, and sunglasses  children under 6 months of age: ask a doctor. Spending time...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 18.2%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For External use only.

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Apply to forehead, cheeks, nose, chin, and neck as the last step in your daytime skincare routine.
  • Apply generously and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating.
  • limit time in the sun, especially from 10 a.m.–2 p.m. 
  • wear long-sleeved shirts, pants, hats, and sunglasses 
  • children under 6 months of age: ask a doctor.

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:  Sun Protection Measures:

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water, C13-15 Alkane, Propanediol, C15-19 Alkane, Caprylic/Capric Triglyceride, Pentylene Glycol, Polyhydroxystearic Acid, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Maltodextrin, Bis-Diglyceryl Polyacyladipate-2, Gluconolactone, Polyacrylate Crosspolymer-6, Inositol, Silica, Arachidyl Alcohol, Polyglycerin-3, Polyglyceryl-3 Lactate/Laurate, Sodium Benzoate, Tocopherol, Bisabolol, Cetearyl Alcohol, Coco- Glucoside, Glucose, Xanthan Gum, Behenyl Alcohol, Sodium Citrate, Sodium Dilauramidoglutamide Lysine, Sclerotium Gum, Fragrance, Arachidyl Glucoside, Citric Acid, Caesalpinia Spinosa Gum, Sodium Phytate, Physalis Alkekengi Calyx Extract, T-Butyl Alcohol, Calcium Gluconate, Helianthus Annuus Sprout Extract, Limonene, Beta-Carotene.

Other Information

SPL UNCLASSIFIED SECTION

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

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-888-950-9595

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

USANAUSANA

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51861-080-002023-02-17C16284748780-1f386c649-f3d0-0266-e053-dadaa90a7c1aUsana Celavive Daily Mineral Protective Cream Moisturizer with Sunscreen SPF 30
51861-080-002023-01-30C16284748780-1f386c649-f3d0-0266-e053-dadaa90a7c1aUsana Celavive Daily Mineral Protective Cream Moisturizer with Sunscreen SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51861-080-00Usana Celavive Daily Mineral Protective Cream Moisturizer with Sunscreen SPF 301 in 1 CARTONCREAM15
51861-080-00Usana Celavive Daily Mineral Protective Cream Moisturizer with Sunscreen SPF 3050 mL in 1 BOTTLE, PLASTICCREAM505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51861-080USANA CELAVIVE DAILY MINERAL PROTECTIVE CREAM MOISTURIZER WITH SUNSCREEN SPF 30 (ZINC OXIDE) CREAM [USANA HEALTH SCIENCES, INC.]5Current NDC, Legacy NDC, 2 package rows20231020_c10c188c-66e0-18ec-e053-2a95a90a5a7d.zip

Products#

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

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51861-08051861-080-00

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 41 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM DILAURAMIDOGLUTAMIDE LYSINEMNJ7VPT2R5IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
WATER059QF0KO0RIACT
C13-15 ALKANE114P5I43UJIACT
PROPANEDIOL5965N8W85TIACT
C15-19 ALKANECI87N1IM01IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
PENTYLENE GLYCOL50C1307PZGIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ISOSTEARIC ACIDX33R8U0062IACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
MALTODEXTRIN7CVR7L4A2DIACT
BIS-DIGLYCERYL POLYACYLADIPATE-26L246LAM9TIACT
GLUCONOLACTONEWQ29KQ9POTIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
INOSITOL4L6452S749IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
POLYGLYCERIN-34A0NCJ6RD6IACT
POLYGLYCERYL-3 LAURATEY9ZSR39D0EIACT
SODIUM BENZOATEOJ245FE5EUIACT
TOCOPHEROLR0ZB2556P8IACT
LEVOMENOL24WE03BX2TIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
COCO GLUCOSIDEICS790225BIACT
ANHYDROUS DEXTROSE5SL0G7R0OKIACT
XANTHAN GUMTTV12P4NEEIACT
DOCOSANOL9G1OE216XYIACT
SODIUM CITRATE1Q73Q2JULRIACT
BETASIZOFIRAN2X51AD1X3TIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CAESALPINIA SPINOSA RESINWL3883U2POIACT
PHYTATE SODIUM88496G1ERLIACT
PHYSALIS ALKEKENGI CALYXAL7F9NO9HRIACT
TERT-BUTYL ALCOHOLMD83SFE959IACT
CALCIUM GLUCONATESQE6VB453KIACT
HELIANTHUS ANNUUS SPROUT4P26HG1S5WIACT
LIMONENE, (+)-GFD7C86Q1WIACT
BETA CAROTENE01YAE03M7JIACT

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
Usana Celavive Daily Mineral Protective Cream Moisturizer with Sunscreen SPF 30ZINC OXIDEUSANA Health Sciences, Inc.c10c188c-66e0-18ec-e053-2a95a90a5a7d2023-10-19WarningsExact identifier
ndc (package): 51861-080-00
ndc (product): 51861-080
ndc11 (package): 51861008000
spl id: 08151a03-10b8-08ea-e063-6394a90a6eeb
spl set id: c10c188c-66e0-18ec-e053-2a95a90a5a7d

Reported adverse events (FAERS/openFDA)#

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