FDA.reportPublic FDA data

Caring mill Sunscreen Spray SPF 50

Manufacturer
FSA Store Inc.
Effective date
2024-01-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:07:36

Label at a glance#

ProductCaring mill Sunscreen SPF 50
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure7 sections

Indications and uses

helps prevent sunburn

Dosage and administration

Shake well before each use Spray liberally and spread evenly by hand 15 minutes before sun exposure  Hold container 4 to 6 inches from the skin to apply Do not spray directly into face. Spray on hands then apply to face. Do not apply in windy conditions  Use in a well-ventilated area Reapply  After 80 minutes of swimming or sweating immediately after towel drying  At least every 2 hours Sun Protection Measures. Sp...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 5%

Purpose 

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only
Flammable:Do not use near heat, flame, or while smoking

Do not use on

OTC - DO NOT USE SECTION

  • damaged or broken skin

When using this product

OTC - WHEN USING SECTION

  • keep away from face to avoid breathing it
  • keep out of eyes. Rinse with water to remove.
  • Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
  • Do not store at temperatures above 120°F.

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake well before each use
  • Spray liberally and spread evenly by hand 15 minutes before sun exposure 
  • Hold container 4 to 6 inches from the skin to apply
  • Do not spray directly into face. Spray on hands then apply to face.
  • Do not apply in windy conditions 
  • Use in a well-ventilated area
  • 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 Spectrum SPF value 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 information

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun. Store between 68°F to 77°F (20°C to 25°C). May stain or damage some fabrics or surfaces.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol(73.9%), Neopentyl Glycol Diheptanoate, Acrylates/Octylacrylamide Copolymer, Fragrance, Butylene Glycol Dicaprylate/Dicaprate, Ascorbyl Palmitate.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81522-952-01Caring mill Sunscreen SPF 50162 mL in 1 BOTTLELIQUID1621

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81522-952CARING MILL SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LIQUID [FSA STORE INC.]1Current NDC, 1 package rows20240120_0ec201dc-c262-cecd-e063-6394a90a3fd3.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81522-95281522-952-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE75D21FL1PIIACT
ASCORBYL PALMITATEQN83US2B0NIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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
Caring mill Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFSA Store Inc.0ec201dc-c262-cecd-e063-6394a90a3fd32024-01-12WarningsExact identifier
ndc (package): 81522-952-01
ndc (product): 81522-952
ndc11 (package): 81522095201
spl id: 0ec201dc-c263-cecd-e063-6394a90a3fd3
spl set id: 0ec201dc-c262-cecd-e063-6394a90a3fd3

Reported adverse events (FAERS/openFDA)#

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