FDA.reportPublic FDA data

Serum Crema

Manufacturer
Pure on Purpose, LLC | Fragrance Manufacturing, Inc.
Effective date
2019-01-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:33:12

Label at a glance#

ProductSerum Crema Broad Spectrum SPF20 Sunscreen
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

• Apply liberally 15 minutes before sun exposure • 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 & other sun protection measures including: • limit time in the sun, especially from 10am–2pm • wear long-sleeved shi...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (non-nano uncoated) 13.5%

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 cancer and early skin aging caused by the sun.

WARNINGS

WARNINGS SECTION

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.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • 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 & other sun protection measures including:
    • limit time in the sun, especially from 10am–2pm
    • wear long-sleeved shirts, pants, hats & sunglasses
    • use a water-resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours

OTHER INFORMATION

OTHER SAFETY INFORMATION

Protect this product from excessive heat & direct sunlight.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Argania Spinosa Kernel Oil* (Argan), Camellia Sinensis (Green Tea) Seed Oil*, Carthamus Tinctorius (Safflower) Seed Oil*, Cera Alba (Beeswax)*, Glycerin*, Glycyrrhiza Glabra (Licorice) Root Extract, Haematococcus Pluvialis Extract (Astaxanthin derived from Plankton), Helianthus Annuus (Sunflower) Seed Oil*, Iron Oxides (CI 77491) & (CI 77492), Jojoba Esters, Persea Gratissima (Avocado) Oil*, Prunus Armeniaca (Apricot) Kernel Oil*, Rosmarinus Officinalis (Rosemary) Leaf Extract, Rubus Idaeus (Raspberry) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil*, Tocopherol (Vitamin E). *denotes certified organic

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VIVE SANA
ORGANIC SUNCARE

SERUM CREMA
PREPARE-DEEPLY NOURISHING ARGAN
PROTECT-NON-NANO UNCOATED ZINC
REBUILD-GREEN TEA & RED RASPBERRY
IMPROVE-PLANKTON & LICORICE ROOT
BROAD SPECTRUM
-SPF 20-
SHEER BRIGHTENING FINISH
100% NATURAL

NET WEIGHT 2 FL. OZ / 59 ML

image-01
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Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71556-200-012023-01-30C16284748780-1f386c649-f363-0266-e053-dadaa90a7c1aSerum Crema Broad Spectrum SPF20 Sunscreen

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71556-200SERUM CREMA BROAD SPECTRUM SPF20 SUNSCREEN (ZINC OXIDE) LOTION [PURE ON PURPOSE, LLC]2Legacy NDC20190125_f28f044a-8f26-4f10-91bf-79be9cc752a7.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71556-20071556-200-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
ARGAN OIL4V59G5UW9XIACT
CAMELLIA SINENSIS SEED OILO5R6DK2M9KIACT
SAFFLOWER OIL65UEH262ISIACT
GLYCERINPDC6A3C0OXIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
HAEMATOCOCCUS PLUVIALIS31T0FF0472IACT
SUNFLOWER OIL3W1JG795YIIACT
AVOCADO OIL6VNO72PFC1IACT
APRICOT KERNEL OIL54JB35T06AIACT
ROSEMARYIJ67X351P9IACT
RASPBERRY SEED OIL9S8867952AIACT
JOJOBA OIL724GKU717MIACT
TOCOPHEROLR0ZB2556P8IACT

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
4d772e5d-0ab3-92a3-e063-6294a90a59e7f28f044a-8f26-4f10-91bf-79be9cc752a72026-03-20WarningsExact identifier
spl set id: f28f044a-8f26-4f10-91bf-79be9cc752a7

Reported adverse events (FAERS/openFDA)#

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