FDA.reportPublic FDA data

Lifeguard

Product NDC
85527-111
11-digit product format
855270111
Labeler code
85527
Product ID
85527-111_33e0b240-26e5-0864-e063-6294a90a9e7f
Type
HUMAN OTC DRUG
Nonproprietary name
Sunscreen
Dosage form
CREAM
Route
TOPICAL
Labeler
SPHERE 8 INC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-01
Substance
OCTISALATE; ZINC OXIDE; OCTOCRYLENE
Active strength
4; 17.18; 5 g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Lifeguard
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE4 g/100mL
ZINC OXIDE17.18 g/100mL
OCTOCRYLENE5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
SOI2LOH54ZInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
32be4eb3-f106-182d-e063-6394a90aa484Available on FDA.report

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

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 216 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlgenistOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDESolazyme, Inc.4ece1847-1c94-4bf7-b936-109556a460a72025-04-22WarningsExact identifier
application number: M020
Sulwhasoo Perfecting Cushion NO.17N1 VanillaOCTINOXATE, TITANIUM DIOXIDE, AND HOMOSALATEAmorepacific Corporation3350f28e-22b4-904c-e063-6394a90a1c812025-04-21WarningsExact identifier
application number: M020
Neutrogena Sheer Zinc Kids Mineral Sunscreen Broad Spectrum SPF 50 PlusZINC OXIDEKenvue Brands LLCc914c4cd-99a2-4d9f-8f04-8af2ace3c3452025-04-18WarningsExact identifier
application number: M020
Charlis Neutral Tinted Face Moisturizer Mineral Sunscreen SPF 25ZINC OXIDECHARLIS LLC330f7470-0d53-7361-e063-6394a90a5d592025-04-18WarningsExact identifier
application number: M020
Chardonnay Lip OilAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEVacation Inc1318a429-d382-f5b8-e063-6394a90a3bd42025-04-18WarningsExact identifier
application number: M020
Shimmer OilAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEVacation Inc.131c63ba-57fc-9ce8-e063-6294a90acd922025-04-18WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC055431a6-e9e0-99b4-e063-6394a90acb112025-04-17WarningsExact identifier
application number: M020
SILKEN pore perfecting sunscreen broad spectrum SPF 35OCTISALATE, ZINC OXIDETATCHA INC.251566a1-0e21-4030-9d4e-52c4a8bd33302025-04-16WarningsExact identifier
application number: M020
Dermatone SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDermatone Labs LLC32e5bddf-a0b5-c511-e063-6294a90aaf662025-04-16WarningsExact identifier
application number: M020
Sunscreen Lip Balm SPF 30 Cool MintAVOBENZONE 3%, HOMOSALATE 7%, OCTISALATE 4.5%, OCTOCRYLENE 9%USRX3271ab14-3bf5-a24f-e063-6294a90a59bc2025-04-16WarningsExact identifier
application number: M020
goodal GREEN TANGERINE VITA C DARK SPOT UV DEFENSE SUNSCREEN SPF50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONECLIO COSMETICS Co., Ltd.77a0d190-f558-474b-89d2-c79b37c50c0d2025-04-16WarningsExact identifier
application number: M020
Brush On Block SPF 30 Mineral Powder Touch of Tan Zinc Only - REFILLZINC OXIDESPF Ventures, LLC32ccb93a-50cf-f436-e063-6294a90a24922025-04-15WarningsExact identifier
application number: M020
DECORTE SUN SHELTER MULTI PROTECTION Sunscreen SPF 50 Broad SpectrumAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATEKOS America, Inc.2b41c17d-1394-0c2f-e063-6394a90a0c492025-04-15WarningsExact identifier
application number: M020
Urban Antioxidant Sunscreen SPF 40HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXYIDE CREAMDr. Loretta, LLC930150a3-08bb-17fd-e053-2995a90a786b2025-04-15WarningsExact identifier
application number: M020
Cicapair Soothing Color Correcting Treatment Cica Complex Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEHave & Be Co., Ltd.32c1aba6-5e29-aba9-e063-6394a90a8e562025-04-14WarningsExact identifier
application number: M020
REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRYOCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC07701e11-8a7e-44c5-b46e-5b48264eacad2025-04-14WarningsExact identifier
application number: M020
Dr.Ceuracle HYDRA BARRIER SUNSCREENZINC OXIDELeegeehaam Cosmetics22c05215-4983-b32e-e063-6394a90a9f672025-04-13WarningsExact identifier
application number: M020
No7 Protect and Perfect Intense Advanced Day Cream SPF 30AVOBENZONE,OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS3285e28d-5716-b576-e063-6294a90a89052025-04-11WarningsExact identifier
application number: M020
No7 Protect and Perfect Intense Advanced Fragrance Free Day Cream SPF 30AVOBENZONE,OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS32876315-f81f-fdd2-e063-6394a90ad5f72025-04-11WarningsExact identifier
application number: M020
No7 Future Renew Damage Reversal Day Cream Sunscreen Broad Spectrum SPF 25AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS3287ae2e-759e-31c5-e063-6394a90a892f2025-04-11WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85527-111-1185527011111236 mL in 1 BOTTLE (85527-111-11) 236 ml2025-05-01NoNoCurrent