Home NDC 42851-053-01 ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION
Product NDC 42851-053
Requested package NDC 42851-053-01
11-digit product format 428510053
Labeler code 42851
Product ID 42851-053_a4491254-f344-5973-e053-2a95a90a5b49
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide
Dosage form LOTION
Route TOPICAL
Labeler ZO Skin Health, Inc.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2018-01-02
Marketing end 0000-00-00
Substance TITANIUM DIOXIDE
Active strength 82 mg/mL
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42851-053-01 ZO Skin Health ZO Favorites (Mothers Day GWP) 15 mL in 1 BOTTLE, PUMP LOTION 15 mL 82 mg in 1mL 2 42851-053-01 ZO SKIN HEALTH RENEW 15 mL in 1 BOTTLE, PUMP LOTION 15 mL 82 mg in 1mL 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TITANIUM DIOXIDE ACTIVE INGREDIENT 15FIX9V2JP ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 TITANIUM DIOXIDE ACTIVE MOIETY 15FIX9V2JP ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 ALUMINUM HYDROXIDE INACTIVE INGREDIENT 5QB0T2IUN0 ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 BEHENYL BEHENATE INACTIVE INGREDIENT K8NU647RJ0 ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) INACTIVE INGREDIENT 8INO2K35FA ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 CYCLOMETHICONE 5 INACTIVE INGREDIENT 0THT5PCI0R ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) INACTIVE INGREDIENT 9E4CO0W6C5 ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 DIMETHICONOL (40 CST) INACTIVE INGREDIENT 343C7U75XW ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 ETHYL FERULATE INACTIVE INGREDIENT 5B8915UELW ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 ETHYLHEXYLGLYCERIN INACTIVE INGREDIENT 147D247K3P ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 HEXYL LAURATE INACTIVE INGREDIENT 4CG9F9W01Q ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 MEDIUM-CHAIN TRIGLYCERIDES INACTIVE INGREDIENT C9H2L21V7U ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 MELAMINE INACTIVE INGREDIENT N3GP2YSD88 ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 METHYLISOTHIAZOLINONE INACTIVE INGREDIENT 229D0E1QFA ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 MYRISTOYL PENTAPEPTIDE-4 INACTIVE INGREDIENT PMA59A699X ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 PENTYLENE GLYCOL INACTIVE INGREDIENT 50C1307PZG ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 PHENYL TRIMETHICONE INACTIVE INGREDIENT DR0K5NOJ4R ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 POLY(METHYL METHACRYLATE; 450000 MW) INACTIVE INGREDIENT Z47NNT4J11 ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 POLYGLYCERYL-3 DIOLEATE INACTIVE INGREDIENT D08AL46IU2 ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 POLYGLYCERYL-4 ISOSTEARATE INACTIVE INGREDIENT 820DPX33S7 ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 ROSEMARY INACTIVE INGREDIENT IJ67X351P9 ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 SOYBEAN GERM INACTIVE INGREDIENT JBW2VHD14M ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 SQUALANE INACTIVE INGREDIENT GW89575KF9 ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 SUNFLOWER OIL INACTIVE INGREDIENT 3W1JG795YI ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 TOCOPHEROL INACTIVE INGREDIENT R0ZB2556P8 ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 TRIBEHENIN INACTIVE INGREDIENT 8OC9U7TQZ0 ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 TRIETHOXYCAPRYLYLSILANE INACTIVE INGREDIENT LDC331P08E ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 URIDINE MONOPHOSPHATE DISODIUM INACTIVE INGREDIENT KD8E20071T ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 VITAMIN A PALMITATE INACTIVE INGREDIENT 1D1K0N0VVC ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42851-053 ZO SKIN HEALTH RENEW (TITANIUM DIOXIDE) KIT [ZO SKIN HEALTH, INC.] 2 Legacy NDC 20200618_3da6948a-d424-40b4-85da-0df8783de580.zip 42851-053 ZO SKIN HEALTH ZO FAVORITES (MOTHERS DAY GWP) (TITANIUM DIOXIDE) KIT [ZO SKIN HEALTH, INC.] 2 Legacy NDC 20200618_f0511ded-4e60-4924-812b-c4f32c1065ab.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42851-053-01 42851005301 15 mL in 1 BOTTLE, PUMP (42851-053-01) 15 ml 2018-01-02 0000-00-00 No No Current