84090-002-01.pure Sol Spf 30 Mineral Whipped Sunscreen(shimmer)- Spray 166ml

84090-002-01.pure Sol Spf 30 Mineral Whipped Sunscreen(shimmer)- Spray 166ml
SPL v1
SPL
SPL Set ID 4051ced5-85cf-6211-e063-6394a90a09fc
Route
TOPICAL
Published
Effective Date 2025-10-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-04

Description

Zinc Oxide-15%


Medication Information

Warnings and Precautions

For external use only

When using this product

avoid contact with the eyes. If contact

occurs rinse thoroughly with water.

Stop use and ask a doctor if

rash or irritation develops and lasts.

Indications and Usage

apply generously and evenly to all exposed areas before sun

exposure • reapply as needed or after towel drying, swimming,

perspiring or vigorous activity • children under 6 months of age:

ask a doctor

Dosage and Administration

Apply generously and evenly over whole body 20 minutes before sun exposure. Reapply frequently.

Description

Zinc Oxide-15%

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or

contact a Poison Control Center immediately.

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 sunburn • higher SPF gives more sunburn - protection • helps protect the skin against the harmful effects of - UVA and UVB rays

Section 55106-9

Zinc Oxide-15%


Structured Label Content

Indications and Usage (34067-9)

apply generously and evenly to all exposed areas before sun

exposure • reapply as needed or after towel drying, swimming,

perspiring or vigorous activity • children under 6 months of age:

ask a doctor

Dosage and Administration (34068-7)

Apply generously and evenly over whole body 20 minutes before sun exposure. Reapply frequently.

Warnings and Precautions (34071-1)

For external use only

When using this product

avoid contact with the eyes. If contact

occurs rinse thoroughly with water.

Stop use and ask a doctor if

rash or irritation develops and lasts.

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or

contact a Poison Control Center immediately.

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 sunburn • higher SPF gives more sunburn - protection • helps protect the skin against the harmful effects of - UVA and UVB rays

Section 55106-9 (55106-9)

Zinc Oxide-15%


Advanced Ingredient Data


Raw Label Data

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