FDA.reportPublic FDA data

Sea & Ski Reef-Friendly SPF 50 Lotion 1.5oz

Manufacturer
Cross Brands Contract Filling
Effective date
2021-02-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:38:19

Label at a glance#

ProductSea and Ski SPF 50
Active ingredientAVOBENZONE, HOMOSALATE, 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: after 80 minutes of swimming or sweting immediately after towl 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 ...

Storage and handling

protect this product from excessive heat and direct sun may stain some fabrics, wood, plastics, vinyl for use on skin only store between 20°-25°C (68°-77°F).

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredientsActive ingredients

Avobenzone 3.0%, Homsalate 15.0%, Octisalate 7.0%, Octocrylene 8.0%

Purpose

OTC - PURPOSE SECTION

Purpose SectionPurpose Section

Sunscreen

Uses

INDICATIONS & USAGE SECTION

useuse

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 AND PRECAUTIONS SECTION

WarningsWarnings

For External Use Only

Do Not Use

OTC - DO NOT USE SECTION

Do not useDo not use

on damaged or broken skin.

When Using this product

OTC - DO NOT USE SECTION

When usingWhen using

keep out of eyes. Rinse with water to remove

Stop Use and ask a doctor if

OTC - STOP USE SECTION

Stop useStop use

rash occurs

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of childrenKeep out of reach of children

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

Directions

DOSAGE & ADMINISTRATION SECTION

DirectionsDirections

apply liberally 15 minutes before sun exposure. reapply:

after 80 minutes of swimming or sweting

immediately after towl 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-sleeved shirts, pants, hats and sunglasses

Children under 6 months: Ask a doctor.

Other Information

STORAGE AND HANDLING SECTION

Other informationOther information

protect this product from excessive heat and direct sun

may stain some fabrics, wood, plastics, vinyl

for use on skin only

store between 20°-25°C (68°-77°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredientsInactive ingredients

acrylates copolymer, acrylates/c10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, butylene glycol, carbomer, dimethicone, disodium EDTA, ethylhexyl palmitate, ethylhexylglycerin, fragrance, glycerin, hydroxypropyl methylcellulose, neopentyl glycol diheptanoate, phenoxyethanol, simmondsia chinensis (jojoba) extract, sorbitan monooleate, styrene/ acrylates

Questions or comments?

OTC - QUESTIONS SECTION

Questions or CommentsQuestions or Comments

Call 855-sea-n-ski (855-732-6754) or visit www. seaNski.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Front LabelFront Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73440-2156-12023-01-30C16284748780-1f386c64a-148d-0266-e053-dadaa90a7c1aSea & Ski Reef-Friendly SPF 50 Lotion 1.5oz

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73440-2156-1Sea and Ski SPF 5042.5 g in 1 TUBELOTION42.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73440-2156SEA AND SKI SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [CROSS BRANDS CONTRACT FILLING]2Legacy NDC, 1 package rows20210220_b1a37f1f-1981-d1ce-e053-2995a90ac401.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73440-215673440-2156-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT

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
bbb36937-2b3e-aa2c-e053-2a95a90ac1ebb1a37f1f-1981-d1ce-e053-2995a90ac4012021-02-19WarningsExact identifier
spl id: bbb36937-2b3e-aa2c-e053-2a95a90ac1eb
spl set id: b1a37f1f-1981-d1ce-e053-2995a90ac401

Reported adverse events (FAERS/openFDA)#

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