Protect and Prime Broad Spectrum SPF30

Manufacturer
Emma Hardie Ltd
Effective date
2023-11-10
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:59:56

Label at a glance#

ProductProtect and Prime Broad Spectrum SPF30
Active ingredientAVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE
Label structure7 sections

Dosage and administration

Apply generously 15 minutes before sun exposure Use a Water Resistant sunscreen if swimming or sweating Reapply at least every 2 hours 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. Limit time in the sun, especially...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Octinoxate 7.5%

Octocrylene 10%

Oxybenzone 6%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply generously 15 minutes before sun exposure
  • Use a Water Resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • 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.
  • Limit time in the sun, especially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses

Other information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), caprylic/capric triglyceride, Green Wattle (Acacia Decurrens)/Jojoba (Simmondsia Chinensis)/Sunflower (Helianthis Annus) Seed Wax/Polyglyceryl-3 Esters, HDI/Trimethylol Hexyllactone Crosspolymer, Tapioca Starch, Manketti (Schinziophyton Rautaneii) Kernel Oil, Shea Butter (Vitellaria Paradoxa), Stearic Acid, Glycerin, Butylene Glycol Stearate SE, Phenoxyethanol, Benzyl Alcohol, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Fragrance (Parfum), Polyhydroxystearic Acid, Geraniol, Limonene, Citronellol, Xanthan Gum, Linalool, Alumina, Aluminum Stearate, Disodium EDTA, Ethylhexylglycerin, Dehydroacetic Acid, Silica, Sodium Stearate, Polymethylsilsesquioxane, Disodium Rutinyl Disulfate, Barley (Hordeum Districhon) Extract, Lemon Balm (Melissa Officinalis) Leaf Extract, Sodium Benzoate, Citral, Citric Acid, Farnesol, Titanium Dioxide (CI 77891)

Package Labling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage LabelDrug Facts PanelDrug Facts Panel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70453-001-01Protect and Prime Broad Spectrum SPF301 in 1 BOXCREAM15
70453-001-01Protect and Prime Broad Spectrum SPF3050 mL in 1 BOTTLECREAM505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70453-001PROTECT AND PRIME BROAD SPECTRUM SPF30 (AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [EMMA HARDIE LTD]5Legacy NDC, 2 package rows20231111_cdd6ffe3-2ae6-44d8-a9b8-45bb134e928c.zip

Products#

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

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70453-00170453-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

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
09c78b92-8f3e-7c88-e063-6394a90a370ccdd6ffe3-2ae6-44d8-a9b8-45bb134e928c2023-11-10WarningsExact identifier
spl id: 09c78b92-8f3e-7c88-e063-6394a90a370c
spl set id: cdd6ffe3-2ae6-44d8-a9b8-45bb134e928c

Reported adverse events (FAERS/openFDA)#

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