foundation medium spectrum

foundation medium spectrum
SPL v1
SPL
SPL Set ID 273f4d65-b245-c27a-e063-6394a90ade07
Route
topical
Published
Effective Date 2024-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (5 g) octinoxate (7.5 g) titanium dioxide
Inactive Ingredients
cyclomethicone peg-10 dimethicone (900 cst) ci 77492 sodium chloride silica methacrylic acid water ethylcellulose, unspecified polyvinyl alcohol, unspecified isopropyl palmitate ci 77499 ci 77491 erythritol aloe vera leaf extract sorbitol glycerin phenoxyethanol c8-10 trialkylmethyl quaternary ammonium chlorides sorbitan sesquioleate magnesium stearate propylene glycol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-11-19

Description

Octyl Methoxycinnamate 7.5% Zinc Oxide 5% Titanium Dioxide 5%


Medication Information

Warnings and Precautions

For external use only

Active Ingredient

Octyl Methoxycinnamate 7.5%

Zinc Oxide 5%

Titanium Dioxide 5%

Indications and Usage

helps prevent sunbum

if used as directed with other sunprotection measures (see Directions)decreases the risk of skin cancer andearly skin aging caused by the sun

Dosage and Administration

Apply liberally and evenly 15 minutesbefore sun exposure

Reapply at least every two hours

Use a water-resistant sunscreen ifswimming or sweating

Sun Protection Measures. Spendingtime in the sun increases your risk ofskin cancer and early skin aging.Todecrease this risk, regularly use asunscreen with a Broad Spectrum SPFvalue of 15 or higher and other sunprotection measures including:- Limit time in the sun, especially from10 a.m.- 2 p.m.-Wear long-sleeved shirts, pants, hatsand sunglasses

children under 6 months of age:Ask a doctor

Description

Octyl Methoxycinnamate 7.5% Zinc Oxide 5% Titanium Dioxide 5%

Section 50565-1

Keep out of reach of children.

lf swallowed, contact a physician orpoison control center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

When using this product keep out ofeyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin

Section 51727-6

Quaternary ammonium compounds

ISOPROPYL PALMITATE

Dimethyl cyclosiloxane

SILICA

PEG-10 Dimethicone

SORBITAN SESQUIOLEATE

MAGNESIUM STEARATE

Methacrylic acid

WATER

GLYCERIN

Propylene glycol

sodium chloride

Erythritol

CI 77492

CI 77491

CI 77499

Sorbitol powder

Aloe Vera Extract

2-phenoxyethanol

Poly(vinyl alcohol)

Ethyl cellulose

Section 51945-4

Section 55105-1

Sunscreen


Structured Label Content

Warnings and Precautions (34071-1)

For external use only

Active Ingredient (55106-9)

Octyl Methoxycinnamate 7.5%

Zinc Oxide 5%

Titanium Dioxide 5%

Indications and Usage (34067-9)

helps prevent sunbum

if used as directed with other sunprotection measures (see Directions)decreases the risk of skin cancer andearly skin aging caused by the sun

Dosage and Administration (34068-7)

Apply liberally and evenly 15 minutesbefore sun exposure

Reapply at least every two hours

Use a water-resistant sunscreen ifswimming or sweating

Sun Protection Measures. Spendingtime in the sun increases your risk ofskin cancer and early skin aging.Todecrease this risk, regularly use asunscreen with a Broad Spectrum SPFvalue of 15 or higher and other sunprotection measures including:- Limit time in the sun, especially from10 a.m.- 2 p.m.-Wear long-sleeved shirts, pants, hatsand sunglasses

children under 6 months of age:Ask a doctor

Section 50565-1 (50565-1)

Keep out of reach of children.

lf swallowed, contact a physician orpoison control center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

When using this product keep out ofeyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 51727-6 (51727-6)

Quaternary ammonium compounds

ISOPROPYL PALMITATE

Dimethyl cyclosiloxane

SILICA

PEG-10 Dimethicone

SORBITAN SESQUIOLEATE

MAGNESIUM STEARATE

Methacrylic acid

WATER

GLYCERIN

Propylene glycol

sodium chloride

Erythritol

CI 77492

CI 77491

CI 77499

Sorbitol powder

Aloe Vera Extract

2-phenoxyethanol

Poly(vinyl alcohol)

Ethyl cellulose

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)