FDA.reportPublic FDA data

Sun Guard

Manufacturer
Saje Natural Business Inc
Effective date
2026-01-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:33:17

Label at a glance#

ProductSun Guard
Active ingredientZINC OXIDE
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20%

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

Helps protect against sunburn.

WARNINGS SECTION

For external use only.

Do not use if foil seal is broken or missing

OTC - DO NOT USE SECTION

Do not use • on damaged or broken skin • if you are pregnant or breastfeeding • if you are allergic to plants in the Asteraceae/Compositae/Daisy family

OTC - WHEN USING SECTION

When using this product, keep out of eyes. Rinse with water to remove

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION


Directions • Apply liberally and evenly 15 minutes before sun exposure • Children under 6 months of age: ask a doctor • Reapply as needed or after towel drying, swimming or sweating. • Reapply at least every 2 hours • Use water resistant sunscreen if swimming or sweating.

OTHER SAFETY INFORMATION

• Protect the product in this container from excessive heat and direct sun. • Sun alert: Limiting sun exposure, wearing protective clothing and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.

Questions? 1-877-275-7253

distributed by : saje natural wellness 22 east 5th ave vancouver, bc canada v5t 1g8 saje.com 1-877-ask-saje @sajewellness made by our friends in canada

INACTIVE INGREDIENT SECTION

Anthemis nobilis flower oil, beeswax (white), calendula officinalis flower, chamomilla recutita (matricaria) flower extract, daucus carota sativa (carrot) seed oil, hippophae rhamnoides fruit extract, olive oil, pelargonium graveolens oil, rosmarinus officinalis (rosemary) leaf extract , santalum album (sandalwood) oil, soybean oil, sunflower oil, vitamin e.

DESCRIPTION SECTION

SPF 30 Broad-Spectrum Sunscreen Lotion
3.4 fl. oz. | 100ml
6.1 fl. oz. | 180 ml

SUN GUARD - Outer label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

180 ml180 ml100 ml100 ml

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70983-02470983-024-02, 70983-024-01, 70983-024-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
HIPPOPHAE RHAMNOIDES FRUITAVL0R9111TIACT
OLIVE OIL6UYK2W1W1EIACT
PELARGONIUM GRAVEOLENS FLOWERING TOP1P36QZP48PIACT
ROSEMARYIJ67X351P9IACT
SOYBEAN OIL241ATL177AIACT
SUNFLOWER OIL3W1JG795YIIACT
CHAMAEMELUM NOBILE FLOWER OILUB27587839IACT
WHITE WAX7G1J5DA97FIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CARROT SEED OIL595AO13F11IACT
SANDALWOOD OILX7X01WMQ5FIACT
ALPHA-TOCOPHEROLH4N855PNZ1IACT
CHAMOMILEFGL3685T2XIACT
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun GuardZINC OXIDESaje Natural Business Inc87ee593d-668c-f592-e053-2a95a90a17b12026-01-13WarningsExact identifier
ndc (package): 70983-024-01
ndc (package): 70983-024-02
ndc (package): 70983-024-03
ndc (product): 70983-024
ndc11 (package): 70983002402
ndc11 (package): 70983002401
ndc11 (package): 70983002403
spl id: 4851c3b3-b351-8628-e063-6294a90ad4ba
spl set id: 87ee593d-668c-f592-e053-2a95a90a17b1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.