FDA.reportPublic FDA data

Avobenzone, Homosalate, Octisalate, Octocrylene

Manufacturer
Retail Business Services, LLC | Nice-Pak Products, LLC
Effective date
2026-02-06
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:37:08

Label at a glance#

ProductAvobenzone, Homosalate, Octisalate, Octocrylene
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure12 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (See Directions ), decreases the rist of skin cancer and early skin aging caused by the sun

Dosage and administration

apply liberaly 15 minutes before sun exposure apply to all skin exposed to the sun 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 value of 15 or higher and other sun protection...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octisalate 4.5%

Octocrylene 8%

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 rist 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

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberaly 15 minutes before sun exposure
  • apply to all skin exposed to the sun
  • 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 value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especialy from 10  a.m. -2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses
  • children under 6 months of age: Ask a doctor

Other information

OTHER SAFETY INFORMATION

  • protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, aluminum starch octenylsuccinate, styrene/acrylates copolymer, behenyl alcohol, glyceryl stearate, benzyl alcohol, PEG-100 stearate, polyester-7, tocopherol, arachidyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, arachidyl glucoside, chlorphenesin, beeswax, silica, neopentyl glycol diheptanoate, potassium hydroxide, disodium EDTA

ADVERSE REACTION

ADVERSE REACTIONS SECTION

May stain or damage some fabrics or surfaces

Dist by Foodhold USA, LLC Landover, MD 20733  1877-846-9949

(c)2019 S&S Brands, LLC Quality guaranteed or your money back

*This product is not manufactured or distributed by Bayer, distributor of Coppertone Sunscreen Lotion Water Babies Pure & Simple Broad spectrum SPF 50

**Oxybenzone & Octinoxate free

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CareOne

Compare to Coppertone Sunscreen Lotion Water Babies SPF 50*

Baby

Sunscreen Lotion

SPF 50

UVA/UVB protection

Broad Spectrum SPF 50

  • Water resistant (80 minutes)

Reef friendly**

8 FL OZ (236 mL)

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72476-950-34Avobenzone, Homosalate, Octisalate, Octocrylene236 mL in 1 BOTTLE, PLASTICLOTION2366

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72476-95072476-950-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW)5Z4DPO246AIACT
DOCOSANOL9G1OE216XYIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
BENZYL ALCOHOLLKG8494WBHIACT
PEG-100 STEARATEYD01N1999RIACT
POLYESTER-70841698D2FIACT
TOCOPHEROLR0ZB2556P8IACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
CHLORPHENESINI670DAL4SZIACT
YELLOW WAX2ZA36H0S2VIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
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
Avobenzone, Homosalate, Octisalate, OctocryleneSUNSCREENRetail Business Services, LLC1dc325bb-d520-4897-b8f8-3f0ecba2274c2026-02-06Warnings, Adverse reactionsExact identifier
ndc (package): 72476-950-34
ndc (product): 72476-950
ndc11 (package): 72476095034
spl id: 4a2c81ab-5eae-7d10-e063-6394a90abd2f
spl set id: 1dc325bb-d520-4897-b8f8-3f0ecba2274c

Reported adverse events (FAERS/openFDA)#

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