FDA.reportPublic FDA data

SUNSCREEN

Manufacturer
220 Laboratories Inc
Effective date
2010-05-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:24:33

Label at a glance#

ProductSUNSCREEN WATER RESISTANT
Active ingredientHOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE
Label structure10 sections

Storage and handling

Flammable Do not use near heat, open flame or while smoking. Do not puncture or incinerate. Contents under pressure. Do not store at temperature about 120°F (49°C). Avoid long term storage about 104°F (40°C).

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients                                              Purpose

Butyl Methoxydibenzoylmethane 3.0%................................Sunscreen

Homosalate 15.0%............................................................Sunscreen

Benzophenone-3 5.0%.......................................................Sunscreen

Octocrylene 2.0%..............................................................Sunscreen

Ethylhexyl Salicylate 5.0%.................................................Sunscreen

OTC - WHEN USING SECTION

When Using this product

  • Keep out of reach of children
  • Keep out of eyes. Rinse with water to remove.
  • Do not use if allergic to any ingredient.
  • If swallowed, get medical help or contact Poison Control Center immediately.

WARNINGS SECTION

Warnings

  • For external use only
  • Do not spray directly into face
  • Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

OTC - ASK DOCTOR SECTION

Stop use and ask doctor if
  • Rash or irritation develops.

STORAGE AND HANDLING SECTION

Flammable

  • Do not use near heat, open flame or while smoking.
  • Do not puncture or incinerate. Contents under pressure.
  • Do not store at temperature about 120°F (49°C).
  • Avoid long term storage about 104°F (40°C).

DOSAGE & ADMINISTRATION SECTION

Directions

  • Apply generously and evenly to all areas 15 minutes before sun exposure.
  • Spray on hands and apply to face.
  • Use in well-ventilated area.
  • Reapply to dry skin as needed.
  • Ask doctor before use on children under six months of age.

GENERAL PRECAUTIONS SECTION

Other Information

Sun Alert: Limiting sun exposure, wearing protective clothing and using sunscreens may reduce the risk of skin aging, skin cancer and other harmful effects of the sun.

INACTIVE INGREDIENT SECTION

Other Ingredients

Butane, Alcohol Denat., Taploca Starch, Zinc Oxide, Retinyl Palmitate, Zea Mays (Corn) oil, Cholecalciferol, Tocopheryl Acetate, Panthenol, Tetrahexyldecyl Ascorbate, Ascorbyl Palmitate, Acrylates/Octylacylamide Copolymer, Fragrance (Parfum)

OTC - PURPOSE SECTION

Active Ingredients                                               Purpose

Butyl Methoxydibenzoylmethane 3.0%................................Sunscreen

Homosalate 15.0%............................................................Sunscreen

Benzophenone-3 5.0%.......................................................Sunscreen

Octocrylene 2.0%..............................................................Sunscreen

Ethylhexyl Salicylate 5.0%.................................................Sunscreen

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Zinka Clear continuous sunscreen spray
Mega mist water resistant
Broad spectrum
UVA/UVB Protection
Non-greasy, no slip grip
Fast and even application
SPF 30 Spray Artwork
SPF 30 Spray Artwork


DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57367-029-052019-10-21C16284748780-1956f9ecf-c08a-621f-e053-dbdaa90a74adSPF-30 Artwork

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57367-029-05SUNSCREENWATER RESISTANT106 g in 1 CANAEROSOL, SPRAY1062

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57367-029SUNSCREEN WATER RESISTANT (HOMOSALATE OXYBENZONE OCTISALATE AVOBENZONE OCTYLCRYLENE) AEROSOL, SPRAY [220 LABORATORIES INC]2Legacy NDC, 1 package rows20100518_6ff3b386-8a20-47de-992c-3d7b5556f5bb.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX2
HOMOSALATEACTIVE INGREDIENTV06SV4M95S2
OCTISALATEACTIVE INGREDIENT4X49Y0596W2
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM2
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y2
AVOBENZONEACTIVE MOIETYG63QQF2NOX2
HOMOSALATEACTIVE MOIETYV06SV4M95S2
OCTISALATEACTIVE MOIETY4X49Y0596W2
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM2
OXYBENZONEACTIVE MOIETY95OOS7VE0Y2
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW82
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0N2
BENZYL BENZOATEINACTIVE INGREDIENTN863NB338G2
BENZYL SALICYLATEINACTIVE INGREDIENTWAO5MNK9TU2
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF412
CORN OILINACTIVE INGREDIENT8470G57WFM2
COUMARININACTIVE INGREDIENTA4VZ22K1WT2
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z2
STARCH, TAPIOCAINACTIVE INGREDIENT24SC3U704I2
TETRAHEXYLDECYL ASCORBATEINACTIVE INGREDIENT9LBV3F07AZ2
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVC2
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54Z2

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
57367-02957367-029-05

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
HOMOSALATEV06SV4M95SACTIB
STARCH, TAPIOCA24SC3U704IIACT
OXYBENZONE95OOS7VE0YACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ZINC OXIDESOI2LOH54ZIACT
COUMARINA4VZ22K1WTIACT
BENZYL SALICYLATEWAO5MNK9TUIACT
PANTHENOLWV9CM0O67ZIACT
BENZYL BENZOATEN863NB338GIACT
ASCORBYL PALMITATEQN83US2B0NIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
CORN OIL8470G57WFMIACT
CHOLECALCIFEROL1C6V77QF41IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 31 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CORN OILCORN OIL8470G57WFMTABLET, CHEWABLE / ORALNAExact identifier — unii candidate
11 equally ranked IID candidates
STARCH, TAPIOCASTARCH, TAPIOCA24SC3U704ICAPSULE / ORAL100 mgExact identifier — unii candidate
2 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZSOLUTION / INTRAVENOUS3.11 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
ASCORBYL PALMITATEASCORBYL PALMITATEQN83US2B0NTABLET / ORAL7.14 mgExact identifier — unii candidate
6 equally ranked IID candidates
ASCORBYL PALMITATEASCORBYL PALMITATEQN83US2B0NSUPPOSITORY / RECTAL16 mgExact identifier — unii candidate
6 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE, DL-.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8OINTMENT / TOPICALNAExact identifier — unii candidate
2 equally ranked IID candidates
ASCORBYL PALMITATEASCORBYL PALMITATEQN83US2B0NSYSTEM / TOPICAL0.04 mgExact identifier — unii candidate
6 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMTABLET, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
11 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMINJECTION / INTRAMUSCULARNAExact identifier — unii candidate
11 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMCAPSULE / ORAL918 mgExact identifier — unii candidate
11 equally ranked IID candidates
BENZYL BENZOATEBENZYL BENZOATEN863NB338GINJECTION, SOLUTION / INTRAMUSCULAR750 mgExact identifier — unii candidate
4 equally ranked IID candidates
STARCH, TAPIOCASTARCH, TAPIOCA24SC3U704ITABLET / ORAL5 mgExact identifier — unii candidate
2 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMTABLET, COATED / ORAL10 mgExact identifier — unii candidate
11 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZLOTION / TOPICAL16 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
BENZYL BENZOATEBENZYL BENZOATEN863NB338GSOLUTION / INTRAMUSCULAR447 mgExact identifier — unii candidate
4 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMTABLET / SUBLINGUAL1.7 mgExact identifier — unii candidate
11 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMTABLET / ORAL20 mgExact identifier — unii candidate
11 equally ranked IID candidates
BENZYL BENZOATEBENZYL BENZOATEN863NB338GINJECTION / INTRAMUSCULAR1500 mgExact identifier — unii candidate
4 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE, DL-.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8AEROSOL, FOAM / TOPICALNAExact identifier — unii candidate
2 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZINJECTION / SUBCUTANEOUS0.02 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMSUSPENSION / ORAL2.5 ml/5mlExact identifier — unii candidate
11 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMTABLET, DELAYED RELEASE / ORAL0.03 mgExact identifier — unii candidate
11 equally ranked IID candidates
ASCORBYL PALMITATEASCORBYL PALMITATEQN83US2B0NSOLUTION / TOPICALNAExact identifier — unii candidate
6 equally ranked IID candidates
ASCORBYL PALMITATEASCORBYL PALMITATEQN83US2B0NCREAM / TOPICAL0.02 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
BENZYL BENZOATEBENZYL BENZOATEN863NB338GCAPSULE / ORALNAExact identifier — unii candidate
4 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZSUPPOSITORY / RECTAL375 mgExact identifier — unii candidate
6 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMCREAM / TOPICALNAExact identifier — unii candidate
11 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMSUSPENSION, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
11 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZSOLUTION / RESPIRATORY (INHALATION)3.11 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZINJECTION, SUSPENSION / SUBCUTANEOUSNAExact identifier — unii candidate
6 equally ranked IID candidates
ASCORBYL PALMITATEASCORBYL PALMITATEQN83US2B0NCAPSULE / ORAL12 mgExact identifier — unii candidate
6 equally ranked IID candidates

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
b0602558-795b-4916-b143-74d0e6e6a84c6ff3b386-8a20-47de-992c-3d7b5556f5bb2010-05-17WarningsExact identifier
spl id: b0602558-795b-4916-b143-74d0e6e6a84c
spl set id: 6ff3b386-8a20-47de-992c-3d7b5556f5bb

Reported adverse events (FAERS/openFDA)#

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