TROPICAL OTTERS Glitter Sunscreen SPF-50 - Fragrance Free

Manufacturer
6174 INDUSTRIES, LLC
Effective date
2024-03-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:09:26

Label at a glance#

ProductTROPICAL OTTERS Glitter Sunscreen SPF-50 - Fragrance Free
Active ingredientHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE
Label structure8 sections

Indications and uses

Helps prevent sunburn.  Higher SPF gives more sunburn protection. Retains SPF after 80 minutes of swimming or sweating. 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 liberally15 minutes before sun exposure and as needed. Children under 6 months of age: ask a doctor. 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 othe...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 10.00%
Octisalate 5.00%
Octocrylene 5.00%
Zinc Oxide 4.00%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn. 
  • Higher SPF gives more sunburn protection.
  • Retains SPF after 80 minutes of swimming or sweating.
  • 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.

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 or irritation develops and lasts.

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.

If pregnant or breast-feeding, 

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • 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-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

Acrylates Copolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyloctyl Salicylate, Calendula Officinalis Extract, Camellia sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Oil, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Cocos Nucifera (Coconut) Oil, Cosmetic Glitter (Polyethylene Terephthalate, Polymethyl Methacrylate, Polyurethane 33), Daucus Carota Sativa (Carrot) Extract, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Lactobacillus Ferment, Phenoxyethanol, Polysorbate-20, Punica Granatum (Pomegranate) Extract, Rubus Idaeus (Rasberry) Extract, Sorbitan Olivate, Styrene/Acrylates Copolymer, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol, FD&C Blue #1, FD&C Yellow #5.

Questions?

OTC - QUESTIONS SECTION

1-980-202-1769

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

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
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84164-461-00TROPICAL OTTERS Glitter Sunscreen SPF-50 - Fragrance Free133 mL in 1 TUBECREAM1331

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84164-461TROPICAL OTTERS GLITTER SUNSCREEN SPF-50 - FRAGRANCE FREE (HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE) CREAM [6174 INDUSTRIES, LLC]1Current NDC, 1 package rows20240307_658b1b20-6540-4f3a-ac9a-170bc8fcba11.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84164-46184164-461-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 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
TROPICAL OTTERS Glitter Sunscreen SPF-50 - Fragrance FreeHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE6174 INDUSTRIES, LLC658b1b20-6540-4f3a-ac9a-170bc8fcba112024-03-06WarningsExact identifier
ndc (package): 84164-461-00
ndc (product): 84164-461
ndc11 (package): 84164046100
spl id: 12fad27d-d6ff-6872-e063-6294a90a9586
spl set id: 658b1b20-6540-4f3a-ac9a-170bc8fcba11

Reported adverse events (FAERS/openFDA)#

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