SPL v1
SPL
SPL Set ID 3d510061-eeb6-990c-e063-6394a90a30a0
Route
TOPICAL
Published
Effective Date 2025-08-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (15 g)
Inactive Ingredients
Hydroxyacetophenone Gentiana Scabra Root Edetate Disodium Okra Peg-7 Glyceryl Cocoate 1,2-hexanediol Dipotassium Glycyrrhizate Calcium Sodium Borosilicate Stearic Acid Hydrogenated Jojoba Oil/jojoba Oil, Randomized (iodine Value 64-70) Butylene Glycol Peg-12 Dimethicone Butane Propylene Glycol Peg-100 Monostearate Sodium Hyaluronate Propane Glycerin Glyceryl Stearate Silver Isobutane Trolamine Cetostearyl Alcohol Water Palmitic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-27

Description

Zinc Oxide(nano) 15%


Medication Information

Warnings and Precautions

For extemal use onl,.

Do not use on damaged or broken skn,

When using this product keep out of cyes, Rinse withwater to remowe,

Siop use and ask a doctor if rash cccurs.Keep out of reach of children, lf product is swalkawed, getmedical help or contact a Potson Conirol Centre right away.Wlay stain some fabrics.

Indications and Usage

1.Avoid contact with eyes. lf it gets into eye accidentally, please rinse with clean water 2. This product is pressure pocked. Do not impact. Keep away from fire out of reach of children.3. Due to differences in human constitution, this product may have adheres reactions an a few people you feel uncontactable, please stop using

4. Do not puncture the product and empty cans or show then into fire.5. Please store in a dry and place below40℃, avoid high temperature and direct sunlight

Dosage and Administration

Directions: Apply liberaly 15 minues before sunexposure, e Reapply: After 80 minutes of swimming or seating,. lmmedabely after touel drying.. At leastevery 2 hours,

Description

Zinc Oxide(nano) 15%

Section 50565-1

keep out of children to use it

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

Apply liberaly 15 minues before sunexposure,

Reapply: After 80 minutes of swimming orsseating,

lmmedabely after touel drying.. At leastevery 2 hours,

Section 51727-6

Water (Aqua)

Butane

Isobutane

Propane

Glycerin

PEG-17 Dimethicone

Propylene Glycol

Stearic Acid

Palmitic Acid

Triethanolamine

Glyceryl Stearate

PEG-100 Stearate

PEG-7 Glyceryl Cocoate

Jojoba Wax PEG-120 Esters

Cetearyl Alcohol

Hydroxyacetophenone

1,2-Hexanediol

Butylene Glycol

Gentiana Scabra Root Extract

Dipotassium Glycyrrhizate

Calcium SodiumBorosilicate

Silver

Sodium Hyaluronate

Disodium EDTA

Hibiscus Esculentus Fruit Extract

Section 51945-4

Section 55105-1

Helps prevent sunbum, if used as directed withother sun protection measures (see Direciions), decreasesthe risk of skin cancer and eary aging caused by the sun

Section 55106-9

Zinc Oxide(nano) 15%


Structured Label Content

Indications and Usage (34067-9)

1.Avoid contact with eyes. lf it gets into eye accidentally, please rinse with clean water 2. This product is pressure pocked. Do not impact. Keep away from fire out of reach of children.3. Due to differences in human constitution, this product may have adheres reactions an a few people you feel uncontactable, please stop using

4. Do not puncture the product and empty cans or show then into fire.5. Please store in a dry and place below40℃, avoid high temperature and direct sunlight

Dosage and Administration (34068-7)

Directions: Apply liberaly 15 minues before sunexposure, e Reapply: After 80 minutes of swimming or seating,. lmmedabely after touel drying.. At leastevery 2 hours,

Warnings and Precautions (34071-1)

For extemal use onl,.

Do not use on damaged or broken skn,

When using this product keep out of cyes, Rinse withwater to remowe,

Siop use and ask a doctor if rash cccurs.Keep out of reach of children, lf product is swalkawed, getmedical help or contact a Potson Conirol Centre right away.Wlay stain some fabrics.

Section 50565-1 (50565-1)

keep out of children to use it

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

Apply liberaly 15 minues before sunexposure,

Reapply: After 80 minutes of swimming orsseating,

lmmedabely after touel drying.. At leastevery 2 hours,

Section 51727-6 (51727-6)

Water (Aqua)

Butane

Isobutane

Propane

Glycerin

PEG-17 Dimethicone

Propylene Glycol

Stearic Acid

Palmitic Acid

Triethanolamine

Glyceryl Stearate

PEG-100 Stearate

PEG-7 Glyceryl Cocoate

Jojoba Wax PEG-120 Esters

Cetearyl Alcohol

Hydroxyacetophenone

1,2-Hexanediol

Butylene Glycol

Gentiana Scabra Root Extract

Dipotassium Glycyrrhizate

Calcium SodiumBorosilicate

Silver

Sodium Hyaluronate

Disodium EDTA

Hibiscus Esculentus Fruit Extract

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Helps prevent sunbum, if used as directed withother sun protection measures (see Direciions), decreasesthe risk of skin cancer and eary aging caused by the sun

Section 55106-9 (55106-9)

Zinc Oxide(nano) 15%


Advanced Ingredient Data


Raw Label Data

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