sunscreen sprays

Manufacturer
Headblock LLC
Effective date
2021-07-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:41:14

Label at a glance#

Productsunscreen sprays
Active ingredientOCTINOXATE
Label structure9 sections

Dosage and administration

Shake well before use. Apply liberally 15 minutes before sun exposure and rub into skin. 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 well-ventilated area. Reapply: After 80 minutes of swimming or sweating, immediately after towel drying, or at least every 2 hours. Children under 6 months: Ask a doc...

Storage and handling

Uses: Helps prevent sunburn; if used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

sunscreen sprays

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

ETHYLHEXYL METHOXYCINNAMATE 5% w/w. Purpose: Sunscreen

Purpose

OTC - PURPOSE SECTION

Sunscreen, sunscreen sprays

Use

INDICATIONS & USAGE SECTION

Helps prevent sunburn.If used as directed with other sun protection measures,

decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

Spray away from face to avoid breathing it. Keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If swallowed,get medical help or contact a Poison Control Center right away. Caution: Flammable. Contents under pressure. Do not use near fire, heat or while smoking. Do not puncture or incinerate.Store at temperature below 120F (48℃). Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Directions

DOSAGE & ADMINISTRATION SECTION

Shake well before use. Apply liberally 15 minutes before sun exposure and rub into skin. 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 well-ventilated area. Reapply: After 80 minutes of swimming or sweating, immediately after towel drying, or at least every 2 hours. Children under 6 months: Ask a doctor. Other Information: protect this product from excessive heat and direct sun; may stain some fabrics.

Other information

STORAGE AND HANDLING SECTION

Uses: Helps prevent sunburn; if used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Butane,propane, isobutene, water, cyclopentasiloxane, isohexadecane, alcohol, zincoxide, silica, triethoxycaprylylsilane cyclopentasiloxane, peg/ppg-18/18 dimethicone, dimethicone, methylene bis-benzotriazolyl tetramethylbutylphenol, decyl glucoside, propylene glycol, xanthan gum, C12-15 alkyl benzoate, phenylbenzimidazole sulfonic acid, dioctyldodecyl lauroyl glutamate, polysilicone-15,sodium chloride, sodium hydroxide, cetyl peg/ppg -10/1 dimethicone, butylene glycol, centella asiatica extract, polygonum cuspidatum root extract, polygonum cuspidatum root extract,scutellaria baicalensis root extract,camellia sinensis leaf extract, glycyrrhiza glabra,(licorice) root extract, rosmarinus officinalis (rosemary) leaf extract, chamomilla recutita(matricaria) flower extract, 1,2-hexanediol, phenoxyethanol, citrus paradisi (grapefruit) peel oil, tocopherol,disodium edta

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82080-101-012022-07-29C16284748780-1e4f33bdf-a026-d8a0-e053-dadaa90a6e4esunscreen sprays

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82080-101-01sunscreen sprays141 g in 1 BOTTLESPRAY1411

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82080-101SUNSCREEN SPRAYS (ETHYLHEXYL METHOXYCINNAMATE) SPRAY [HEADBLOCK LLC]1Legacy NDC, 1 package rows20210703_c61c3a8f-eafd-3110-e053-2995a90a05c6.zip

Products#

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

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82080-10182080-101-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

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
c61c3a8f-eaef-3110-e053-2995a90a05c6c61c3a8f-eafd-3110-e053-2995a90a05c62021-07-01WarningsExact identifier
spl id: c61c3a8f-eaef-3110-e053-2995a90a05c6
spl set id: c61c3a8f-eafd-3110-e053-2995a90a05c6

Reported adverse events (FAERS/openFDA)#

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