Australian Gold Botanical Sunscreen 70 Mineral Lotion

Manufacturer
Prime Enterprises Inc.
Effective date
2022-01-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:47:03

Key Label Information#

Active Ingredients And Purpose

Active Ingredients

Titanium Dioxide 4.4% Zinc Oxide 5%

Purpose

Sunscreen

Uses

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

Warnings

Warnings

For external use only

Directions And Dosage

Directions

apply liberally 15 minutes before sun exposure reapply after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours 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 broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses children under 6 months: Ask a doctor

Other Label Information

Inactive Ingredients

Alumina, Butyrospermum Parkii (Shea) Butter, C13-15 Alkane, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cyclopentasiloxane, Dimethicone Crosspolymer, Disodium EDTA, Disterdimonium Hectorite, Eucalyptus Globulus (Eucalyptus) Leaf Extract, Fragrance (Parfum), Glycerin, Hexyl Laurate, Isododecane, Isohexadecane, Panthenol, PEG-10 Dimethicone, Phenoxyethanol, Polyglyceryl-4 Isostearate, Polymethylsilsesquioxane, Porphyra Umbilicalis Extract, Silica, Squalane, Stearic Acid, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Tocopheryl Acetate, Water/Aqua/Eau

Questions or comments?

Call toll free 1-855-LIV-GOLD (548-4653)

Botanical Sunscreen 70 Broad Spectrum SPF 70 Mineral Lotion

Label Images#

label
label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58443-0508-42024-01-30C16284748780-11030e365-03b1-111a-e063-dadaa90a10e2Australian Gold Botanical Sunscreen 70 Mineral Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58443-0508-4Australian GoldBotanicals Sunscreen 70 Minerals147 mL in 1 TUBELOTION1471

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58443-0508AUSTRALIAN GOLD BOTANICALS SUNSCREEN 70 MINERALS (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PRIME ENTERPRISES INC.]1Legacy NDC, 1 package rows20220115_d58df976-b79a-cd8a-e053-2a95a90a8cf6.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-050858443-0508-4

Ingredients#

Complete SPL Sections#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 4.4% Zinc Oxide 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

For external use only

Directions

DOSAGE & ADMINISTRATION SECTION

apply liberally 15 minutes before sun exposure reapply after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours 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 broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses children under 6 months: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alumina, Butyrospermum Parkii (Shea) Butter, C13-15 Alkane, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cyclopentasiloxane, Dimethicone Crosspolymer, Disodium EDTA, Disterdimonium Hectorite, Eucalyptus Globulus (Eucalyptus) Leaf Extract, Fragrance (Parfum), Glycerin, Hexyl Laurate, Isododecane, Isohexadecane, Panthenol, PEG-10 Dimethicone, Phenoxyethanol, Polyglyceryl-4 Isostearate, Polymethylsilsesquioxane, Porphyra Umbilicalis Extract, Silica, Squalane, Stearic Acid, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Tocopheryl Acetate, Water/Aqua/Eau

Other information

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun May stain some fabrics or surfaces

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-855-LIV-GOLD (548-4653)

Botanical Sunscreen 70 Broad Spectrum SPF 70 Mineral Lotion

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML