84090-001-01. Pure Sol Spf 50 Daily Moisturizer-liquid-50ml

84090-001-01. Pure Sol Spf 50 Daily Moisturizer-liquid-50ml
SPL v1
SPL
SPL Set ID 4051506c-fc13-cd22-e063-6394a90a977e
Route
TOPICAL
Published
Effective Date 2025-10-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (12.7 g)
Inactive Ingredients
Cetyl Ethylhexanoate Ethylhexylglycerin Triethoxycaprylylsilane .alpha.-tocopherol Acetate Peg-10 Dimethicone (600 Cst) Phenoxyethanol Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Water Sorbitan Isostearate Disteardimonium Hectorite Butylene Glycol Dicaprylate/dicaprate Cyclomethicone 5 Butylene Glycol Sodium Chloride

Identifiers & Packaging

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

Description

Zinc Oxide 12.5% Sunscreen


Medication Information

Warnings and Precautions

For external use only

Flammable: Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120F. Do not use in the presence of a flame or spark or while smoking.

Do not use on damaged or broken skin

When using this product, keep away from face to avoid breathing it. Keep out of eyes

Rinse with water to remove.

Indications and Usage

Stop use and ask a doctor if rash occurs

Dosage and Administration

spray generously and spread evenly by hand 15 minutes before sun exposure

hold container 4 to 6 inches from the skin to apply

do not spray directly into face. Spray on hands then apply to face

Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad-Spectrum SPF value of 15 or higher and other sun protection measures including:

• limit your time in the sun, especially from 10 a.m. – 2 p.m.

• wear long-sleeved shirts, pants, hats, and sunglasses

Description

Zinc Oxide 12.5% Sunscreen

Section 50565-1

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

Section 51727-6

WATER

CYCLOPENTASILOXANE

TRIETHOXYCAPRYLYLSILANE

BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE

CETYL ETHYLHEXANOATE

BUTYLENE GLYCOL

CETYL PEG/PPG-10/1 DIMETHICONE

PEG-10 DIMETHICONE

SORBITAN ISOSTEARATE

SODIUM CHLORIDE

PHENOXYETHANOL

ETHYLHEXYLGLYCERIN

DISTEARDIMONIUM HECTORITE

WATER

TOCOPHERYL ACETATE

Section 51945-4

Section 55105-1

Helps Prevent Sunburn

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Section 55106-9

Zinc Oxide 12.5% Sunscreen


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs

Dosage and Administration (34068-7)

spray generously and spread evenly by hand 15 minutes before sun exposure

hold container 4 to 6 inches from the skin to apply

do not spray directly into face. Spray on hands then apply to face

Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad-Spectrum SPF value of 15 or higher and other sun protection measures including:

• limit your time in the sun, especially from 10 a.m. – 2 p.m.

• wear long-sleeved shirts, pants, hats, and sunglasses

Warnings and Precautions (34071-1)

For external use only

Flammable: Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120F. Do not use in the presence of a flame or spark or while smoking.

Do not use on damaged or broken skin

When using this product, keep away from face to avoid breathing it. Keep out of eyes

Rinse with water to remove.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

WATER

CYCLOPENTASILOXANE

TRIETHOXYCAPRYLYLSILANE

BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE

CETYL ETHYLHEXANOATE

BUTYLENE GLYCOL

CETYL PEG/PPG-10/1 DIMETHICONE

PEG-10 DIMETHICONE

SORBITAN ISOSTEARATE

SODIUM CHLORIDE

PHENOXYETHANOL

ETHYLHEXYLGLYCERIN

DISTEARDIMONIUM HECTORITE

WATER

TOCOPHERYL ACETATE

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Helps Prevent Sunburn

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Section 55106-9 (55106-9)

Zinc Oxide 12.5% Sunscreen


Advanced Ingredient Data


Raw Label Data

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