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 228 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COOLA Classic Body SPF 50 Fragrance FreeAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCed207afe-0b10-74c7-e053-2a95a90a9b872025-02-17WarningsExact identifier
application number: M020
Avon Skin-So-Soft Bug Guard plus SPF 30 Sunscreen Gentle Breeze Insect Repellent SunscreenOCTINOXATE, OXYBENZONE, OCTISALATEThe Avon Company2e5d6c93-f091-5388-e063-6394a90ad5602025-02-17WarningsExact identifier
application number: M020
KEYS SOULCARE DAILY MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc31a98dc7-4b99-d845-e063-6394a90a26702025-02-17WarningsExact identifier
application number: M020
Ultra sheer mineral sunscreen PRO SPF30ZINC OXIDEEden Brands Inc.2ce06566-2eb0-9a00-e063-6394a90a9ba92025-02-14WarningsExact identifier
application number: M020
Cell Fusion C Laser UV Defense Sunscreen Broad Spectrum SPF 50HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDECMS LAB Inc.2dff0386-e151-089a-e063-6394a90a0f532025-02-14WarningsExact identifier
application number: M020
Cell Fusion C Airy Stick Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECMS LAB Inc.2dffc699-3b56-2c70-e063-6294a90ae2492025-02-14WarningsExact identifier
application number: M020
Sun Defense Minerals (Sheer)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e2082aa-5ae3-2c04-e063-6294a90a140b2025-02-14WarningsExact identifier
application number: M020
Coola SPF 30 Mineral Sunscreen Fragrance FreeZINC OXIDECOOLA, LLCedc6048e-0ea0-41c5-e053-2a95a90a96d92025-02-14WarningsExact identifier
application number: M020
COOLA Classic Body SPF 50 Guava MangoAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCed13afaa-35ec-8326-e053-2995a90adaf02025-02-14WarningsExact identifier
application number: M020
Sun Defense Minerals (Light)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e21f5bb-e7df-b43b-e063-6394a90a0f822025-02-14WarningsExact identifier
application number: M020
Sun Defense Minerals (Fair)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e2102c6-02ea-3a8f-e063-6394a90abf5e2025-02-14WarningsExact identifier
application number: M020
Sunscreen Broad Spectrum SPF 50 Vi AestheticsZINC OXIDE, OCTINOXATEVi Medical Products, INC73620765-c7c0-4bd7-82a9-00022773c9282025-02-14WarningsExact identifier
application number: M020
Sun Defense Minerals (Medium)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e2297d4-3649-a749-e063-6294a90ac2842025-02-14WarningsExact identifier
application number: M020
Sun Defense Minerals (Light)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e22cfde-10a1-3742-e063-6394a90ac0972025-02-14WarningsExact identifier
application number: M020
Cell Fusion C Derma UV Mineral Sunscreen Broad Spectrum SPF 50HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDECMS LAB Inc.2e5c2add-8ed0-a990-e063-6394a90a87ea2025-02-14WarningsExact identifier
application number: M020
Les Duets - Shield of Helios, sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED385f75a5-6a3b-a129-e063-6394a90a52a02025-02-14WarningsExact identifier
application number: M020
Le Mieux Naked Glow Bronzer SPF 50SUNSCREENYB CHEMIA LLC46465db7-c1f0-6980-e063-6294a90a3ed82025-02-14WarningsExact identifier
application number: M020
Sheer Tint Mineral SPF Serum - Light LightZINC OXIDEMineral Fusion brandsac6fdc35-82f8-4805-875e-2aa91aedec6f2025-02-14WarningsExact identifier
application number: M020
Fre Protect Me Lightweight Daily Moisturizer SPF 50ZINC OXIDEPeer Pharm Ltd.3989eebc-7262-4cda-84a1-ca30b638b7722025-02-13WarningsExact identifier
application number: M020
Fre Protect Me Lightweight Daily Moisturizer SPF 30ZINC OXIDEPeer Pharm Ltd.8ee9f97b-9081-4e0c-aa7a-27a31cbee17a2025-02-13WarningsExact 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