FDA.reportPublic FDA data

Lifeguard

Manufacturer
SPHERE 8 INC | HK Kolmar USA LLC
Effective date
2025-04-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:00:04

Label at a glance#

ProductLifeguard
Active ingredientOCTISALATE, ZINC OXIDE, OCTOCRYLENE
Label structure10 sections

Dosage and administration

Shake well prior to use • Apply liberally to dry skin 15 minutes before sun exposure • For topical use only .Keep out of reach of children. For children under 6 months, ask doctor Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the nsk, regularly use a suns een with a Broad-Spectrum SPF value of 15 or higher and other sun protection measures in...

Storage and handling

Protect from excessive heat.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Octisalate 4% Sunscreen

Octocrylene 5% Sunscreen

Zinc Oxide 17.18% Sunscreen

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION


Helps prevent sunburn and photo damage by UV/UVB exposure Higher SPF gives more sunburn protection. 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 SECTION

  • When using this product keep out of eyes. Rinse with water to remove Stop use and ask doctor if rash or irritation occurs Do not use on damaged or broken skin or if allergic to any ingredient If swallowed, get medical help or contact a Poison Control Center

OTC - WHEN USING SECTION

Rinse with water to remove Stop use and ask doctor if rash or irritation occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake well prior to use • Apply liberally to dry skin 15 minutes before sun exposure • For topical use only .Keep out of reach of children. For children under 6 months, ask doctor
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the nsk, regularly use a suns een with a Broad-Spectrum SPF value of 15 or higher and other sun protection measures including: Limit bane in sun, especially from 10am - 2pm
  • Wear long-sleeved stilts, pants, hats, and sunglasses, Reapply to dry skin at least every 2 hours. Use water resistant sunscreen if swimming or sweating.

Other information

STORAGE AND HANDLING SECTION

Protect from excessive heat.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water(Aqua), Boyle* Glycol DicaorylateXicarxete, C12-15 Alkyl Benzoate, Propanedi01, Elutyloctyi Salicylat, CvryliciCapric Triglyteride, Glycerin, Lally PEG-10 Tris(Trimethylsilm) ilyiettyil Dimethiccne, C15-19 Mane, Niaciriamide, Polyglycenii-2 Triisosbearate, Magnesium Stitata-Heolatrydraie, Meleafied Soy can Oil GlycenflOctyklooecanol Polymer, Propylheptyl Caprylata, Silica, Dlabserdirnohlurn Hed01149, Dirnerlipme, Triethoxycaorytylsilane, 1,2-Hexanaciol, Pentlienol, Polyglycerk3 PolydlmeNsfoxyethyl Dinethicone, Propylene Carbonate, Aloe Berbadensis Leaf Juice, DirnethiconelPEG-1015 Crosspolymer, Cactityl Gycol, Glycerii Capritare, Ethyl Ferulate, Tocopherol, tsostearic Acid, Dipropylene Gird, Sodium Citrate

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPF LabelSPF Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85527-111-11Lifeguard236 mL in 1 BOTTLECREAM2364

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85527-111LIFEGUARD (SUNSCREEN) CREAM [SPHERE 8 INC]4Current NDC, 1 package rows20250501_32be4eb3-f106-182d-e063-6394a90aa484.zip

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85527-11185527-111-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
ETHYL FERULATE5B8915UELWIACT
TOCOPHEROLR0ZB2556P8IACT
GLYCERINPDC6A3C0OXIACT
OCTISALATE4X49Y0596WACTIB
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ISOSTEARIC ACIDX33R8U0062IACT
MAGNESIUM SULFATE HEPTAHYDRATESK47B8698TIACT
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)RLA2U05Z4QIACT
SOYBEAN OIL241ATL177AIACT
PROPYLHEPTYL CAPRYLATE991Z19V2ODIACT
DIMETHICONE92RU3N3Y1OIACT
ISODODECANEA8289P68Y2IACT
ZINC OXIDESOI2LOH54ZACTIB
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE75D21FL1PIIACT
PROPANEDIOL5965N8W85TIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
C15-19 ALKANECI87N1IM01IACT
NIACINAMIDE25X51I8RD4IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
PANTHENOLWV9CM0O67ZIACT
PROPYLENE CARBONATE8D08K3S51EIACT
CAPRYLYL GLYCOL00YIU5438UIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
DIPROPYLENE GLYCOLE107L85C40IACT
ALOE VERA LEAF JUICERUE8E6T4NBIACT
CETYL DIGLYCERYL TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE (3500 MM2/S)KB7T6C99UPIACT
POLYGLYCERYL-2 TRIISOSTEARATE68DUY2D39AIACT
SILICAETJ7Z6XBU4IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
DIMETHICONE/PEG-10/15 CROSSPOLYMER21AS8B1BSSIACT
SODIUM CITRATE1Q73Q2JULRIACT

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
LifeguardSUNSCREENSPHERE 8 INC32be4eb3-f106-182d-e063-6394a90aa4842025-04-28WarningsExact identifier
ndc (package): 85527-111-11
ndc (product): 85527-111
ndc11 (package): 85527011111
spl id: 33e0b240-26e5-0864-e063-6294a90a9e7f
spl set id: 32be4eb3-f106-182d-e063-6394a90aa484

Reported adverse events (FAERS/openFDA)#

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