FDA.reportPublic FDA data

COOLA Classic Body Sunscreen SPF 70 - Peach Blossom

Manufacturer
COOLA LLC
Effective date
2023-12-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:05:09

Label at a glance#

ProductCOOLA Classic Body Sunscreen SPF 70 - Peach Blossom
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active Ingredients

Avobenzone 3.0%, Homosalate 5.0%, Octisalate 4.9%, Octocrylene 7.5%

OTC - PURPOSE SECTION

Purpose

Suncreen

INDICATIONS & USAGE SECTION

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 SECTION

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes.

Rinse with water to remove.

Do not use on damaged or broken skin

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.

DOSAGE & ADMINISTRATION SECTION

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 a broad
spection 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 INGREDIENT SECTION

Inactive Ingredients
1,2-Hexanediol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aloe Barbadensis Leaf Juice (ORGANIC), Benzyl Alcohol, Bisabolol (ORGANIC), Brassica Campestris (Rapeseed) Seed Oil, Butyloctyl Salicylate, Camelina Sativa Seed Oil, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes (ORGANIC), Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Citric Acid, Cocos Nucifera (Coconut) Oil*, Decanal*, Dimethyl Heptenal*, Ethyl Acetoacetate*, Ethyl Butyrate*, Ethyl Caproate*, Gamma-Nonalactone*, Gamma Undecalactone*, Gluconolactone, Glycerin (ORGANIC), Hexenyl Acetate*, Hexyl Acetate*, Hydroxyacetophenone, Isoamyl Acetate*, Limnanthes Alba (Meadowfoam) Seed Oil, Mauritia Flexuosa (Buriti) Fruit Oil, Opuntia Ficus-Indica Flower Extract, Pentylene Glycol, Polyacrylate Crosspolymer-6, Prunus Persica (Peach) Flower Extract, Raspberry Ketone*, Rubus Idaeus (Raspberry) Seed Oil, Sodium Benzoate, Sodium Hydroxide, Sodium Phytate, Triethyl Citrate*, Xanthan Gum

OTHER SAFETY INFORMATION

Other information

  • protect this product from excessive heat and direct sun

OTC - QUESTIONS SECTION

Questions or comments?
Call 760-940-2125

COOLA Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPF

70

70%+

Organic

COOLA​®

Classic

Body Sunscreen

Peach Blossom

Ultra Lightweight

Hydrates & Nourishes

+Plant Protection®

Broad Spectrum SPF 70

Water Resistant (80 Minutes)

5.0 FL OZ / 148 mL

©2021 COOLA. Distributed by: COOLA LLC, located in

Sunny & Cool San Diego, CA 92010.  All Rights Reserved.

Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free
*Plant-derived scent constituent. See coola.com for additional detail.

Carton

015-01 Box015-01 Box

Bottle

015-01 Btl015-01 Btl

res

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-015-01COOLA Classic Body Sunscreen SPF 70 - Peach Blossom1 in 1 CARTONCREAM12
79753-015-01COOLA Classic Body Sunscreen SPF 70 - Peach Blossom148 mL in 1 TUBECREAM1482

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-015COOLA CLASSIC BODY SUNSCREEN SPF 70 - PEACH BLOSSOM (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) CREAM [COOLA LLC]2Current NDC, Legacy NDC, 2 package rows20231221_6efa0d9f-0ff3-4b2f-9587-9630261bcbd1.zip

Products#

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

DailyMed product names page 1 of 2 · 45 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79753-01579753-015-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 43 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
1,2-HEXANEDIOLTR046Y3K1GIACT
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER7K68DGG29PIACT
ALOE VERA LEAFZY81Z83H0XIACT
BENZYL ALCOHOLLKG8494WBHIACT
LEVOMENOL24WE03BX2TIACT
BRASSICA RAPA SUBSP. OLEIFERA OILN4G8379626IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CAMELINA SATIVA SEED OIL12824X01L0IACT
CAPRYLYL GLYCOL00YIU5438UIACT
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES9S60Q72309IACT
SAFFLOWER OIL65UEH262ISIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCONUT OILQ9L0O73W7LIACT
DECANAL31Z90Q7KQJIACT
2,6-DIMETHYL-5-HEPTENALZ331YX9EL9IACT
ETHYL ACETOACETATEIZP61H3TB1IACT
ETHYL BUTYRATEUFD2LZ005DIACT
ETHYL CAPROATEFLO6YR1SHTIACT
.GAMMA.-NONALACTONEI1XGH66S8PIACT
.GAMMA.-UNDECALACTONEQB1T0AG2YLIACT
GLUCONOLACTONEWQ29KQ9POTIACT
GLYCERINPDC6A3C0OXIACT
HEXENYL ACETATE, (2Z)-PT792BQ57DIACT
HEXYL ACETATE7U7KU3MWT0IACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
ISOAMYL ACETATEZ135787824IACT
MEADOWFOAM SEED OIL412ZHA4T4YIACT
MAURITIA FLEXUOSA FRUIT OIL48H19MS04LIACT
OPUNTIA FICUS-INDICA LEAF5VM709H93VIACT
PENTYLENE GLYCOL50C1307PZGIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
PRUNUS PERSICA FLOWER19GWB0JENHIACT
4-(P-HYDROXYPHENYL)-2-BUTANONE7QY1MH15BGIACT
RASPBERRY SEED OIL9S8867952AIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM HYDROXIDE55X04QC32IIACT

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 Classic Body Sunscreen SPF 70 - Peach BlossomAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLC6efa0d9f-0ff3-4b2f-9587-9630261bcbd12023-12-20WarningsExact identifier
ndc (package): 79753-015-01
ndc (product): 79753-015
ndc11 (package): 79753001501
spl id: e013ac7e-9756-4d2c-8173-0ef7d53ad729
spl set id: 6efa0d9f-0ff3-4b2f-9587-9630261bcbd1

Reported adverse events (FAERS/openFDA)#

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