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 221 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEB SPF 50 Mangonada Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B3147ef18-9029-6d5b-e063-6394a90acee02025-03-26WarningsExact identifier
application number: M020
HEB SPF 50 Mexican Vanilla Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B31487bad-a756-9050-e063-6394a90acacc2025-03-26WarningsExact identifier
application number: M020
TRADER JOES DAILY FACIAL MINERAL SUNSCREEN SPF 40ZINC OXIDETrader Joe's Company3148c00f-21bb-c05f-e063-6394a90af0e82025-03-26WarningsExact identifier
application number: M020
HEB SPF 50 Chamomile and Lavender Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B314b8147-fe7a-0698-e063-6394a90a872c2025-03-26WarningsExact identifier
application number: M020
HEB SPF 50 Shine Sunscreen with Vitamin C Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B314bcf42-ca01-0fa5-e063-6294a90a5fc82025-03-26WarningsExact identifier
application number: M020
Superactive Moisturizer SPF 50 Hydrating SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMurad, LLC1e5d494b-dccf-4ba1-89de-0bb4ba5b8d382025-03-26WarningsExact identifier
application number: M020
Superactive Moisturizer SPF 50 Wrinkle Fighting SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEMurad, LLCac6163fb-dbc1-432f-a590-86d31c93b29b2025-03-26WarningsExact identifier
application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Deep FairLight Neutral Tan Rich Honey LightMedium and Neutral MediumTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCe17dc640-30e9-441b-a212-ef1508af79442025-03-25WarningsExact identifier
application number: M020
Lip Balm SPF15 VanillaLIP BALM SPF15 VANILLALS Promotions Inc312d0dc5-3933-ecfe-e063-6294a90a9b662025-03-25WarningsExact identifier
application number: M020
Lip Balm SPF15 Blueberry CobblerLIP BALM SPF15 BLUEBERRY COBBLERLS Promotions Inc312fb7b0-86a9-ca88-e063-6294a90a76c82025-03-25WarningsExact identifier
application number: M020
Lip Balm SPF15 PeppermintLIP BALM SPF15 PEPPERMINTLS Promotions Inc3130be1c-0167-2389-e063-6394a90aa61d2025-03-25WarningsExact identifier
application number: M020
Drs. pharmacy sunscreen SPF 30SUNSCREEN SPF 30OL PHARMA TECH LLC. (Drs. Pharmacy)052dea5d-a775-8dc2-e063-6294a90a4f192025-03-25WarningsExact identifier
application number: M020
Drs. pharmacy sunscreen SPF 50SUNSCREEN SPF 50OL PHARMA TECH LLC. (Drs. Pharmacy)0def5c19-b088-2ffb-e063-6394a90aa1092025-03-25WarningsExact identifier
application number: M020
Drs. pharmacy sunscreen SPF 70SUNSCREEN SPF 70OL PHARMA TECH LLC. (Drs. Pharmacy)0def6fa1-b028-fad5-e063-6394a90a19132025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF50 -84521ZINC OXIDEe.l.f. Cosmetics, Inc.31329426-d952-ee5d-e063-6294a90a55f42025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF50 -84520ZINC OXIDEe.l.f. Cosmetics, Inc.31328845-9a67-d237-e063-6294a90a2a7f2025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF50 -84519ZINC OXIDEe.l.f. Cosmetics, Inc.31327ea3-affd-ca13-e063-6294a90a72382025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF50 -84517ZINC OXIDEe.l.f. Cosmetics, Inc.3132641a-e593-a9e8-e063-6294a90acc802025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF50 -84518ZINC OXIDEe.l.f. Cosmetics, Inc.3132669c-e104-ae1e-e063-6294a90aee7f2025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF 50 84514ZINC OXIDEe.l.f. Cosmetics, Inc.31324410-3142-89e1-e063-6294a90a22ee2025-03-25WarningsExact 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