FDA.reportPublic FDA data

Back9ine Skincare Pure Invisible Sunscreen SPF 50

Product NDC
85536-585
11-digit product format
855360585
Labeler code
85536
Product ID
85536-585_335d5ea9-9bfc-ed5c-e063-6394a90aa169
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Dosage form
GEL
Route
TOPICAL
Labeler
Back 9ine Skincare, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-31
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30; 70; 50; 100 mg/mL; mg/mL; mg/mL; mg/mL
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
Back9ine Skincare Pure Invisible Sunscreen SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE70 mg/mL
OCTISALATE50 mg/mL
OCTOCRYLENE100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal 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
974ede40-cfb5-4612-b168-5d42dd137f63Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85536-585-00Back9ine Skincare Pure Invisible Sunscreen SPF 501 in 1 BOXGEL11
85536-585-00Back9ine Skincare Pure Invisible Sunscreen SPF 5050 mL in 1 BOTTLE, PUMPGEL501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85536-585BACK9INE SKINCARE PURE INVISIBLE SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) GEL [BACK 9INE SKINCARE, LLC]1Current NDC, 2 package rows20250424_974ede40-cfb5-4612-b168-5d42dd137f63.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 208 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Reef safe - Baby zinc sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED385f320c-9144-78b8-e063-6394a90a2e9d2025-06-25WarningsExact identifier
application number: M020
Reef safe - Zinc Sport sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED385ff227-1656-960a-e063-6294a90a913c2025-06-25WarningsExact identifier
application number: M020
Thermasun SPF50 Mineral Zinc facial sunscreenZINC OXIDE SUNSCREENVEGANIC SKN LIMITED386ecba0-2f7f-9178-e063-6394a90a44c42025-06-25WarningsExact identifier
application number: M020
Reefsun sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED386ec055-4ae7-9d2d-e063-6394a90a83c02025-06-25WarningsExact identifier
application number: M020
SR Active Sheer Zinc Face Stick SPF 5020.6% ZINC OXIDESkinresource.md, L.L.C.29928ab0-4467-57cb-e063-6394a90ac4d32025-06-25WarningsExact identifier
application number: M020
Sun Protection SPF 50AVOBENZONE 2.9%, HOMOSALATE 4.0%, OCTISALATE 4.9%, OCTOCRYLENE 9.5%Skinresource.md, L.L.C.2a0c3dd1-4bc0-6664-e063-6294a90af4b32025-06-25WarningsExact identifier
application number: M020
MELAO WHITENING SUNSCREENTITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd1aaf5942-ff13-ee07-e063-6394a90acd282025-06-25WarningsExact identifier
application number: M020
Blooskim BEEF TALLOW SUNSCREENNON-NANO ZINC OXIDEGuangzhou Haishi Biological Technology Co., Ltd.384903fa-e739-08b8-e063-6394a90a76532025-06-24WarningsExact identifier
application number: M020
Walgreens SPF 55 Sheer Face Mist SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf05b45e2-2fcd-631e-e053-2995a90ad3342025-06-24WarningsExact identifier
application number: M020
Walgreens SPF 50 Premium Moisturizing Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY0b2b1ed5-8e53-00f3-e063-6394a90a14f82025-06-24WarningsExact identifier
application number: M020
Walgreens Double Restorative Moisturizer Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY38569431-56b6-5f56-e063-6394a90ad24f2025-06-24WarningsExact identifier
application number: M020
Shade SPF30 Climate ControlOCTISALATE, OCTOCRYLENE, ZINC OXIDEMicro Current Technology, Inc.34080e9c-1637-cf25-e063-6394a90ace762025-06-24WarningsExact identifier
application number: M020
Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEAruba Aloe Balm NVcca65f6a-935f-48d4-a07d-831ab6027db02025-06-24WarningsExact identifier
application number: M020
Reef safe - Hydrating sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED385e8966-963d-0814-e063-6394a90a06e32025-06-24WarningsExact identifier
application number: M020
COLLAGEN GLOW MINERAL SUNSCREEN SPF 50ZINC OXIDENAKED SUNDAYS PTY LTDf76a4f0d-e3a6-4bd4-b1ab-09d690976d962025-06-23WarningsExact identifier
application number: M020
LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON ACIDO HIALURONICO FPS 20 SERUM FOUNDATION WITH HYALURONIC ACID SPF 20 CHAMPAGNE 170-NOCTINOXATE, ZINC OXIDEBEL STAR SAf459c27e-e607-47ba-e053-2a95a90a901f2025-06-22WarningsExact identifier
application number: M020
BISUTANG SunscreenBISUTANG SUNSCREENGuangdong Bisutang Biotechnology Co Ltd37fdb01b-929e-6a60-e063-6394a90a94e02025-06-20Exact identifier
application number: M020
AVON BEYOND GLOW SUN MILKAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENELG HOUSEHOLD & HEALTH CARE LTD.38045f75-42c0-7abb-e063-6294a90a8db62025-06-20WarningsExact identifier
application number: M020
Double Use Compact SPF 15 gold deluxe edition Claire 1-2-3OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBel Star S.A. (Colombia)b3747373-ef67-89ff-e053-2995a90afcde2025-06-20WarningsExact identifier
application number: M020
LBEL DIVINE Double Use compact SPF 15 gold deluxe edition Obscure 8-9ZINC OXIDE, TITANTIUM DIOXIDE, OCTINOXATEBel Star S.A. (Colombia)b5e47c63-7e82-34fc-e053-2a95a90a767c2025-06-20WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85536-585-00855360585001 BOTTLE, PUMP in 1 BOX (85536-585-00) / 50 mL in 1 BOTTLE, PUMP2025-01-31NoNoCurrent