FDA.reportPublic FDA data

Sun Guard

Product NDC
70983-024
11-digit product format
709830024
Labeler code
70983
Product ID
70983-024_4851c3b3-b351-8628-e063-6294a90ad4ba
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Saje Natural Business Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-05-09
Substance
ZINC OXIDE
Active strength
20 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Sun Guard
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
87ee593d-668c-f592-e053-2a95a90a17b1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70983-024-01Sun Guard100 mL in 1 TUBELOTION1005
70983-024-02Sun Guard180 mL in 1 TUBELOTION1805
70983-024-03Sun Guard50 mL in 1 TUBELOTION505
70983-024-03Sun Guard1 in 1 BOXLOTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70983-024SUN GUARD (ZINC OXIDE) LOTION [SAJE NATURAL BUSINESS INC]4Current NDC, Legacy NDC, 4 package rows20231006_87ee593d-668c-f592-e053-2a95a90a17b1.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 341 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bareMinerals Original Foundation Broad Spectrum SPF 15 Golden Fair 04TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLCe486915b-8097-451a-a018-3279213239b32023-10-04WarningsExact identifier
application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Deepest Deep 30ZINC OXIDEOrveon Global US LLC4054b48e-d8be-4542-9b43-4437c250579b2023-10-04WarningsExact identifier
application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Golden Deep 28TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLC5b51df09-40c3-4064-96d3-b7366fc838262023-10-04WarningsExact identifier
application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Fairly Medium 05TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLCf1714e23-030c-4bd9-b9e7-111c3813ed342023-10-04WarningsExact identifier
application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Medium Dark 23TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLC828fe263-f223-45c3-9710-fd8d59ad56b12023-10-04WarningsExact identifier
application number: M020
bareMinerals Multi-Tasking SPF 20 Concealer BisqueTITANIUM DIOXIDEOrveon Global US LLCd4c30bea-8c56-4ed8-8ec4-f1b1e0e456dd2023-10-04WarningsExact identifier
application number: M020
BareMinerals Mineral VeilTITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLC64b163dd-8a86-483f-8dab-80fa8740b12f2023-10-04WarningsExact identifier
application number: M020
Laura Mercier Pure Canvas Primer Protecting Broad Spectrum SPF 30 SunscreenOCTINOXATE, OCTOCRYLENE, AVOBENZONE, AND OXYBENZONELaura Mercier US Buyer LLCe7903f3d-9c59-f397-e053-2995a90a78952023-10-04WarningsExact identifier
application number: M020
Laura Mercier Tinted Moisturizer Light Revealer Natural Skin Illuminator Broad Spectrum SPF 25 Sunscreen 0N1 PetalAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENELaura Mercier US Buyer LLCe78e17bf-5606-1031-e053-2a95a90adb352023-10-04WarningsExact identifier
application number: M020
Laura Mercier Tinted Moisturizer Natural Skin Perfector Broad Spectrum SPF 30 Sunscreen 0N1 PetalAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONELaura Mercier US Buyer LLCe78f9689-2f8b-1524-e053-2995a90adc792023-10-04WarningsExact identifier
application number: M020
Laura Mercier Flawless Skin Repair Day Creme Broad Spectrum SPF 15 SunscreenAVOBENZONE, OCTINOXATE, AND OXYBENZONELaura Mercier US Buyer LLCe931d389-6b3d-5a7d-e053-2a95a90a7aa32023-10-04WarningsExact identifier
application number: M020
BANANA BOATZINC OXIDEEdgewell Personal Care Brands LLC05bbe530-df26-e598-e063-6394a90a0c592023-10-03WarningsExact identifier
application number: M020
Native Facial Care Brightening Facial Moisturizer Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Companyded27678-0df8-deda-e053-2a95a90a06582023-09-28WarningsExact identifier
application number: M020
CLEAR IMPROVEMENT PORE CLEARING MOISTURIZERSALICYLIC ACIDORIGINS NATURAL RESOURCES INC.6f9d87fb-2026-4226-b182-ff2a3c40460d2023-09-12WarningsExact identifier
application number: M020
DR ANDREW WEILS FOR ORIGINS MEGA-DEFENSE ADVANCED DAILY UV DEFENDER BROAD SPECTRUM SPF 45TITANIUM DIOXIDE AND ZINC OXIDEORIGINS NATURAL RESOURCES INC.11248cab-c3a5-4e16-8280-9f70bb863cf72023-09-11WarningsExact identifier
application number: M020
PLANTSCRIPTION SPF 25 POWER ANTI AGING BROAD SPECTRUM 25AVOBENZONE, HOMOSALATE, OCTISLATE, AND OCTOCRYLENEORIGINS NATURAL RESOURCES INC.c706fed8-f215-4c53-bfc5-2bd87b8f884e2023-09-11WarningsExact identifier
application number: M020
AnubisMedSPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSIONANUBIS COSMETICS SLe99d92c4-8768-9c0a-e053-2a95a90a609e2023-09-05WarningsExact identifier
application number: M020
Anubis Barcelona Protective LineETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENEANUBIS COSMETICS SLec83846f-11c0-8f59-e053-2995a90ab9d22023-09-01WarningsExact identifier
application number: M020
eos Natural SPF 15 Lip Balm Pineapple CoconutZINC OXIDEeos Products LLC039ca738-c2c1-41c8-e063-6394a90ab4c42023-08-23WarningsExact identifier
application number: M020
Safeguard SPF 40ZINC OXIDESkinsalvation Skincare, Inc.4730721b-6148-4a80-a749-13c4febf2e382023-07-14WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70983-024-0170983002401100 mL in 1 TUBE (70983-024-01) 100 ml2019-05-090000-00-00NoNoCurrent
70983-024-0270983002402180 mL in 1 TUBE (70983-024-02) 180 ml2019-05-090000-00-00NoNoCurrent
70983-024-03709830024031 TUBE in 1 BOX (70983-024-03) / 50 mL in 1 TUBE1 tube2019-06-250000-00-00NoNoCurrent