The Enriched Creme Broad Spectrum SPF 15

Manufacturer
Rationale Group Pty Ltd
Effective date
2023-11-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:19:20

Label at a glance#

ProductThe Enriched Creme Broad Spectrum SPF 15
Active ingredientZINC OXIDE
Label structure9 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 ageing caused by the sun. see Directions

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply  At least every 2 hours  Use a water resistant sunscreen if swimming or sweating. Spending time in the sun increases your risk of skin cancer and early skin ageing. 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, espec...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 12%

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure.
  • Reapply 
  • At least every 2 hours 
  • Use a water resistant sunscreen if swimming or sweating.
  • Spending time in the sun increases your risk of skin cancer and early skin ageing. 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 -2p.m.
  • Wear long sleeved shirts, pants, hats and sunglasses.
  • Children under 6 months of age: Ask a doctor. 

Other Information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua (Water), Dimethicone , Glycerin, Pentylene Glycol, PEG-10 Dimethicone, Tribehenin PEG-20 Esters, Ethylhexyl Methoxycrylene, Coco-Caprylate, Polyhydroxystearic Acid, Propanediol, Argania Spinosa Kernel Oil, Dimethicone Crosspolymer, Polyurethane-62, Tocopheryl Acetate, CI 77891 (Titanium Dioxide), Polyacrylamide, 1,2-Hexanediol, Silica, C13-14 Isoparaffin, Maltodextrin, Mica, Sodium Potassium Aluminum Silicate, Tocopherol, Butylene Glycol, Limonene, Tocotrienols, Laureth-7, Caprylhydroxamic Acid, Disodium EDTA, Hydrolyzed Keratin, Santalum Spicatum (Sandalwood) Seed Oil, Trideceth-10, Voandzeia Subterranea Seed Extract, Behenyl Alcohol, Bisabolol, Polyglyceryl-10 Pentastearate, Helianthus Annuus (Sunflower) Seed Oil, Citrus Aurantium Dulcis (Orange) Oil, Anigozanthos Flavidus Flower Extract, Davidsonia Jerseyana Fruit Extract, Syzygium Luehmannii Fruit Extract, Tin Oxide, Citric Acid, Ceteareth-25, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Grandis (Grapefruit) Peel Oil, Citrus Limon (Lemon) Peel Oil, Fructose, Litsea Cubeba Fruit Oil, Sodium Hydroxide, Urea, Citral, Citrus Aurantium Bergamia (Bergamot) Leaf Oil, Juniperus Mexicana Oil, Pelargonium Graveolens Oil, Citrus Aurantium Amara (Bitter Orange) Flower Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Sodium Stearyl Lactylate, CI 77491 (Iron Oxides), Ceramide NP, 7-Dehydrocholesterol, Cetyl Alcohol, Elaeis Guineensis (Palm) Oil, Melanin, Allantoin, Maltose, Sodium Chloride, Sodium Lactate, Sodium PCA, Trehalose, Magnesium Aspartate, Zinc Gluconate, Linalool, Behenic Acid, Ceramide AP, Cholesterol, Ceramide NG, Phytosphingosine, Ceramide NS Sodium Hyaluronate, Glycine, Acetyl Tetrapeptide-22, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Serine, Glutamic Acid, Ceramide EOP, Ceramide EOS, Copper Gluconate, Glucose, Aspartic Acid, Leucine, Caprooyl Phytosphingosine, Caprooyl Sphingosine, Alanine, Lysine, Ethylhexylglycerin, Arginine, Tyrosine, Phenylalanine, Proline, Threonine, Valine, Isoleucine, Histidine.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling:3ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SFC33SFC33

3ml5ml333ml5ml33

ml3ml3

Package Labeling:5ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SFC1SFC1

3ml5mlC3ml5mlC

ml5ml5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83108-000THE ENRICHED CREME BROAD SPECTRUM SPF 15 (ZINC OXIDE) EMULSION [RATIONALE GROUP PTY LTD]4Legacy NDC20231205_c1a6c10f-ec93-4126-ae43-199462db183e.zip

Products#

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

DailyMed product names page 1 of 3 · 96 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83108-00083108-000-00, 83108-000-03, 83108-000-05

Ingredients#

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

DailyMed ingredient rows page 1 of 3 · 94 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
37626d8c-a276-3824-e063-6394a90a1a72c1a6c10f-ec93-4126-ae43-199462db183e2025-06-12WarningsExact identifier
spl set id: c1a6c10f-ec93-4126-ae43-199462db183e

Reported adverse events (FAERS/openFDA)#

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