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 202 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KARA VITA Moisturizing Sunscreen with DNArescueOXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATEKara Vita, Inc.2130e9ac-5946-4b00-94d0-a78fd1ccfd132025-07-25WarningsExact identifier
application number: M020
78 x 36 SPF 30 ActiveZINC OXIDEDermazone LLC96a8aacc-5c2f-410a-8fb4-8b3bc0f81e552025-07-25WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 01N LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L2ccf4e45-4cec-417d-9f4c-28f376025f1d2025-07-25WarningsExact identifier
application number: M020
celazome Moisturizing SPF 30 ActiveOXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATEDermazone LLC5ec1510d-1465-4849-9e23-f16e11ff0e652025-07-25WarningsExact identifier
application number: M020
Skinuva Scar plusZINC OXIDEMD Medical Designs, Inc.5fcad8c3-a268-4966-b0a9-6cd2c7afd3b72025-07-25WarningsExact identifier
application number: M020
celazome Moisturizing SPF 29 Active with DNArescueOXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATEDermazone LLC99fb90ca-6527-459b-8af2-627ea9abe11b2025-07-25WarningsExact identifier
application number: M020
The Men Pen TALLOW GUARD SPF 30 PREMIUM ZINC SUNSCREENZINC OXIDEGuangzhou Haishi Biological Technology Co., Ltd.3aa93f52-ec01-01c2-e063-6294a90a93472025-07-24WarningsExact identifier
application number: M020
Mineral Suscreen SPF 30ZINC OXIDE 19.0%Vivant Pharmaceuticals, LLC3aadb658-d12d-ae8d-e063-6394a90a64962025-07-24WarningsExact identifier
application number: M020
SunscreenTITANIUM DIOXIDE 6.8%Baxter of California, LLC146030bc-2bf4-25ea-e063-6294a90a46132025-07-24WarningsExact identifier
application number: M020
Leg and Body Makeup Broad Spectrum SPF 25OCTISALATE 3.2% OCTOCRYLENE 6%Baxter of California, LLC14adc826-6e9d-382a-e063-6294a90a5d792025-07-24WarningsExact identifier
application number: M020
Tiege Hanley AM Morning Facial Moisturizer with SPF 20AVOBENZENE, OCTINOXATE, OCTOCRYLENETIEGE HANLEY, Inc22086cd8-2126-120e-e063-6394a90a561e2025-07-24WarningsExact identifier
application number: M020
Tulip Dew SHIELD GLOWZINC OXIDEBloomeffects, Inc.150f9660-48ec-a189-e063-6294a90a6d492025-07-23WarningsExact identifier
application number: M020
Pelotan Sunscreen Broad Spectrum SPF 30AVOBENZONE, OCTINOXATE, OCTOCRYLENEPelotan LLC3a9f94eb-98b7-5a20-e063-6394a90a173b2025-07-23WarningsExact identifier
application number: M020
Basin Frosted Orange Cream SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a9fc050-f74f-a431-e063-6294a90ad4c22025-07-23WarningsExact identifier
application number: M020
Pelotan Sunscreen Broad Spectrum SPF 30AVOBENZONE, OCTINOXATE, OCTOCRYLENEPelotan LLC3aa0799b-0790-2476-e063-6294a90a8bcc2025-07-23WarningsExact identifier
application number: M020
The Men Pen TALLOW GUARD SPF 30 PREMIUM ZINC SUNSCREENZINC OXIDEGuangzhou Haishi Biological Technology Co., Ltd.3aa3c442-26a6-0ab0-e063-6294a90a93a52025-07-23WarningsExact identifier
application number: M020
Basin Italian Gelato SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a89106d-dbf0-e6ea-e063-6294a90a60f32025-07-22WarningsExact identifier
application number: M020
Basin American Mint Julep SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a898964-b4aa-e86d-e063-6394a90a34c62025-07-22WarningsExact identifier
application number: M020
No7 Future Renew Damage Reversal System KitAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS3512c120-b8ba-ba59-e063-6394a90ac1e22025-07-22WarningsExact identifier
application number: M020
Basin Lime Sugar SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a89d736-efef-088e-e063-6394a90a5e622025-07-22WarningsExact 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