FDA.reportPublic FDA data

Care One 769.000/769AA Ultra Sunscreen Lotion SPF 30

Manufacturer
American Sales Company | Nice-Pak Products, LLC
Effective date
2026-02-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:37:17

Label at a glance#

ProductSunscreen
Active ingredientOCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATE
Label structure13 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protections 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: 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...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 10%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protections 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 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 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 Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especiallyu 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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, ethylhexyl palmitate, sorbitol, polyamide-8, benzyl alcohol, tocopherol, caprylic/capric triglyceride, triethanolamine, fragrance, acrylates/C10-30 alkyl acrylate crosspolymer, chlorphenesin, sodium ascorbyl phosphate, olethe-3, disodium EDTA

ADVERSE REACTION

ADVERSE REACTIONS SECTION

Distributed by Foodhold USA, LLC

Landover, MD 20785

1-877-849-9949

(C) 2019 S&S Brands, LLC

Quality guaranteed your your money back.

May stain or damage some fabrics or surfaces.

*This product is not manufacured or distribued by Bayer, distributor of Coppertone Ultra Guard Sunscreen Lotion Broad Spectrum SPF 30.

**Oxybenzone & Octinoxate free

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Care One

Compare to Coppertone Ultra Guard Sunscreen Lotion SPF 30*

Sunscreen

Lotion

SPF 30 UVA/UVB Protection

BROAD SPECTRUM SPF 30

  • Water resistant (80 minutes)
  • Enriched with moisturizers
  • Hypoallergenic

REEF FRIENDLY**

8 FL OZ (236 mL)

image descriptionimage description

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-769-34Sunscreen236 mL in 1 BOTTLE, PLASTICLOTION2365

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41520-76941520-769-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
ETHYLHEXYL PALMITATE2865993309IACT
SORBITOL506T60A25RIACT
POLYAMIDE-8 (4500 MW)77723GV81AIACT
BENZYL ALCOHOLLKG8494WBHIACT
TOCOPHEROLR0ZB2556P8IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
TROLAMINE9O3K93S3TKIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
CHLORPHENESINI670DAL4SZIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
OLETH-3BQZ26235UCIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB

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
SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAmerican Sales Company79dff6ec-d958-4bba-999b-da4aa67519f52026-02-06Warnings, Adverse reactionsExact identifier
ndc (package): 41520-769-34
ndc (product): 41520-769
ndc11 (package): 41520076934
spl id: 4a2bed31-4ba3-4427-e063-6294a90ad1cc
spl set id: 79dff6ec-d958-4bba-999b-da4aa67519f5

Reported adverse events (FAERS/openFDA)#

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