FDA.reportPublic FDA data

Coola Anti-Aging Hand Cream Sunscreen

Manufacturer
COOLA LLC | Goodier Cosmetics
Effective date
2025-08-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:10:54

Label at a glance#

ProductCoola Anti-Aging Hand Cream Sunscreen
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE
Label structure9 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 Reapply: At least every 2 hours Use a water resistant sunscreen if swimming or sweating 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 of 15 or higher and other sun protection measures including: Limit time in the sun, especially from:...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone, Octocrylene, Octisalate

Purpose

OTC - PURPOSE SECTION

Avobenzone 2.5%, Octocrylene 7.5%, Octisalate 4.0%..................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

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask doctor if skin rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is 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
  • 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 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

Aloe Barbadensis Leaf Juice (ORGANIC); Cetearyl Alcohol, Oryza Sativa (Rice) Bran Oil (ORGANIC); Caprylic/Capric Triglycderide (ORGANIC); Glycerin (ORGANIC); Stearic Acid, Butyloctyl Salicylate, Mangifera Indica (Mango) Seed Butter (ORGANIC); Sesamum Indicum (Sesame) Seed Oil (ORGANIC); Glyceryl Stearate; Jojoba Esters; Arnica Montana FLower Extract (ORGANIC); Water (Aqua); 1,2-Hexanediol; Glyceryl Stearates; Xanthan Gum; Caprylyl Glycol; Helianthus Annuus (Sunflower) Seed Wax; Sodium Stearoyl Glutamate; Hyroxyacetophenone; Rubus Idaeus (Raspberry) Seed Oil; Carthamus Tinctorius (Safflower) Oleosomes (ORGANIC); Tetrasodium Glutamate Diacetate; Polyglycerin-3; Tropolone; Butylene Glycol; Fragrance (Natural)

Other information

STORAGE AND HANDLING SECTION

  • Protect this product from excessive heat and direct sun
  • May stain fabrics

Questions or comments?

OTC - QUESTIONS SECTION

Call 760-940-2125

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COOLA

SPF 30

Anti-Aging

Hand Cream

Sunscreen

Featuring

Organic Arnica Extract +

Mango Seed Butter

Broad Spectrum SPF 30

2.0 FL OZ / 60 mL

11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-105-01Coola Anti-Aging Hand Cream Sunscreen60 mL in 1 TUBECREAM601

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
79753-10579753-105-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
TROPOLONE7L6DL16P1TIACT
CETEARYL ALCOHOL2DMT128M1SIACT
STEARIC ACID4ELV7Z65APIACT
AVOBENZONEG63QQF2NOXACTIB
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
ORYZA SATIVA (RICE) BRANR60QEP13ICIACT
GLYCERINPDC6A3C0OXIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
RUBUS IDAEUS (RASPBERRY) SEED OIL9S8867952AIACT
HYDROLYZED JOJOBA ESTERSUDR641JW8WIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
BUTYLENE GLYCOL3XUS85K0RAIACT
SESAMUM INDICUM (SESAME) SEED OILQX10HYY4QVIACT
XANTHAN GUMTTV12P4NEEIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
MANGIFERA INDICA (MANGO) SEED BUTTER4OXD9M35X2IACT
GLYCERYL STEARATE230OU9XXE4IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
POLYGLYCERIN-34A0NCJ6RD6IACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX42DG15CHXVIACT
WATER059QF0KO0RIACT
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES9S60Q72309IACT

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
Coola Anti-Aging Hand Cream SunscreenAVOBENZONE, OCTOCRYLENE, OCTISALATECOOLA LLC3c2fbf10-d68e-c601-e063-6294a90a09a32025-08-12WarningsExact identifier
ndc (package): 79753-105-01
ndc (product): 79753-105
ndc11 (package): 79753010501
spl id: 3c2fbf10-d68f-c601-e063-6294a90a09a3
spl set id: 3c2fbf10-d68e-c601-e063-6294a90a09a3

Reported adverse events (FAERS/openFDA)#

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