84090-004-01.pure Sol Spf 37 Tinted Moisturizer- Liquid-30ml

84090-004-01.pure Sol Spf 37 Tinted Moisturizer- Liquid-30ml
SPL v1
SPL
SPL Set ID 4052c4e4-2105-80c0-e063-6294a90af41d
Route
TOPICAL
Published
Effective Date 2025-10-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (9.36 g) Zinc Oxide (3.84 g)
Inactive Ingredients
Ci 77492 Methacrylate/methoxy Peg-10 Maleate/styrene Copolymer Glycerin Butylene Glycol Dicaprylate/dicaprate Polyhydroxystearic Acid Stearate Stearic Acid Ci 77491 Cetyl Peg/ppg-10/1 Dimethicone (hlb 5) Water Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Disteardimonium Hectorite Cyclopentasiloxane Cetyl Ethylhexanoate Dimethicone Triethoxycaprylylsilane Ethylhexylglycerin Silica Sodium Chloride Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Polyhydroxystearic Acid (2300 Mw) Propylene Carbonate Ci 77499 Peg-10 Dimethicone (600 Cst) Phenoxyethanol Aluminum Hydroxide Isononyl Isononanoate

Identifiers & Packaging

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

Description

Zinc Oxide 3.84% TITANIUM DIOXIDE 9.36%


Medication Information

Warnings and Precautions

For external use only Do not use on damaged or broken skin.

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

Stop use and ask a doctor if rash occurs.

Keep out of reach of children.lf swallowed, get medical help or contacta Poison Control Center right away

Flammable. Do not spray near heat sparks, sources of ignition, or flames

Indications and Usage

Apply liberally 15 minutes before sun exposure

Reapply

After 40 minutes of swimming or sweating

Immediately after towel drying

At least every 2 hours

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 of 15 or higher and other sun protection measures including:

Limit time in the sun, especially from 10 a.m. - 2 p.m.

Dosage and Administration

Apply tiberally 15 minutes before sun exposure.

Reapoly. at least every 2 hours or after 40 minutes of swimming or sweating.

Description

Zinc Oxide 3.84% TITANIUM DIOXIDE 9.36%

Section 50565-1

Keep out of reach of children.lf swallowed, get medical help or contacta Poison Control Center right away

Section 51727-6

WATER

ALUMINUM HYDROXIDE

STEARIC ACID

CYCLOPENTASILOXANE

BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE

GLYCERIN

CETYL ETHYLHEXANOATE

DIMETHICONE

TRIETHOXYCAPRYLYLSILANE

CETYL PEG/PPG-10/1 DIMETHICONE

DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER

SILICA

PEG-10 DIMETHICONE

SODIUM CHLORIDE

PHENOXYETHANOL

ETHYLHEXYLGLYCERIN

CI 77492

ISONONYL ISONONANOATE

CETYL PEG/PPG-10/1 DIMETHICONE

POLYHYDROXYSTEARIC ACID

TRIETHOXYCAPRYLYLSILANE

DISTEARDIMONIUM HECTORITE

WATER

CI 77491

ISONONYL ISONONANOATE

DISTEARDIMONIUM HECTORITE

PROPYLENE CARBONATE

CI 77499

POLYHYDROXYSTEARIC ACID

STYRENE/BUTADIENE COPOLYMER

Section 51945-4

Section 55105-1

WATER /SWEATRESISTANT

TINTED SPFMOISTURIZER

Shields skin from UVA/UVBBlue Light & Infrared Rodiotion

Section 55106-9

Zinc Oxide 3.84%

TITANIUM DIOXIDE 9.36%


Structured Label Content

Indications and Usage (34067-9)

Apply liberally 15 minutes before sun exposure

Reapply

After 40 minutes of swimming or sweating

Immediately after towel drying

At least every 2 hours

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 of 15 or higher and other sun protection measures including:

Limit time in the sun, especially from 10 a.m. - 2 p.m.

Dosage and Administration (34068-7)

Apply tiberally 15 minutes before sun exposure.

Reapoly. at least every 2 hours or after 40 minutes of swimming or sweating.

Warnings and Precautions (34071-1)

For external use only Do not use on damaged or broken skin.

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

Stop use and ask a doctor if rash occurs.

Keep out of reach of children.lf swallowed, get medical help or contacta Poison Control Center right away

Flammable. Do not spray near heat sparks, sources of ignition, or flames

Section 50565-1 (50565-1)

Keep out of reach of children.lf swallowed, get medical help or contacta Poison Control Center right away

Section 51727-6 (51727-6)

WATER

ALUMINUM HYDROXIDE

STEARIC ACID

CYCLOPENTASILOXANE

BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE

GLYCERIN

CETYL ETHYLHEXANOATE

DIMETHICONE

TRIETHOXYCAPRYLYLSILANE

CETYL PEG/PPG-10/1 DIMETHICONE

DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER

SILICA

PEG-10 DIMETHICONE

SODIUM CHLORIDE

PHENOXYETHANOL

ETHYLHEXYLGLYCERIN

CI 77492

ISONONYL ISONONANOATE

CETYL PEG/PPG-10/1 DIMETHICONE

POLYHYDROXYSTEARIC ACID

TRIETHOXYCAPRYLYLSILANE

DISTEARDIMONIUM HECTORITE

WATER

CI 77491

ISONONYL ISONONANOATE

DISTEARDIMONIUM HECTORITE

PROPYLENE CARBONATE

CI 77499

POLYHYDROXYSTEARIC ACID

STYRENE/BUTADIENE COPOLYMER

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

WATER /SWEATRESISTANT

TINTED SPFMOISTURIZER

Shields skin from UVA/UVBBlue Light & Infrared Rodiotion

Section 55106-9 (55106-9)

Zinc Oxide 3.84%

TITANIUM DIOXIDE 9.36%


Advanced Ingredient Data


Raw Label Data

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