Spf 50 Mineral Sunscreen Lip

Spf 50 Mineral Sunscreen Lip
SPL v3
SPL
SPL Set ID 1c6f0964-9bee-1c06-e063-6294a90ac2a4
Route
TOPICAL
Published
Effective Date 2024-07-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (4.85 mg) Titanium Dioxide (8 mg)
Inactive Ingredients
Water Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Sorbitan Sesquioleate Isopropyl Palmitate Silicon Dioxide Ethylhexyl Palmitate Trimethylsiloxysilicate (m/q 0.8-1.0) Disteardimonium Hectorite Dimethicone Butylene Glycol Triethoxycaprylylsilane Isohexadecane Glycerin Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Sodium Chloride Peg-30 Dipolyhydroxystearate Tribehenin Magnesium Stearate Phenoxyethanol Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-03

Description

Zinc Oxide 4.85% Titanium Dioxide 8%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Helps prevent sunburn.

if used as directed with other sun protection measures (see Directions)decreases the risk of skin cancer and early skin agingcaused by the sun.

Dosage and Administration

Directions

·Applyliberally15 minutes before sun exposure·Reapply:·after 80 minutes of swimming orsweating·after towel drying, swimming, or·at least every 2 hours ·children under 6 months of age: ask a doctor.

Description

Zinc Oxide 4.85% Titanium Dioxide 8%

Section 50565-1

Keep out of reach of children.lf swallowed, getmedical help or contact Posion Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50567-7

When using this product keep out of eyes.

Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin

Section 51727-6

Water,Dimethicone, lsohexadecane, EthylhexylPalmitate, Butylene Glycol, Glycerin, lsopropyl PalmitateSorbitan Sesquioleate, Cetyl Peg/Ppg-10/ Dimethicone.Silica, Disteardimonium Hectorite, Sodium Chloride,Trimethylsiloxysilicate, Peg-30 Dipolyhydroxystearate,

Tribehenin, Magnesium Stearate, Phenoxyethanol,Triethoxycaprylylsilane Ethylhexylglycerin, PentaerythrityTetra-Di-T-Buty Hydroxyhydrocinnamate

Section 51945-4

Section 53413-1

Please call:1-817-398-8817 or emus at [email protected].

Section 55105-1

Sunscreen

Section 55106-9

Zinc Oxide 4.85%

Titanium Dioxide 8%

Section 60561-8

.Protect this product from excessive heat and direct sun.Sun alert: Limiting sunexposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer,and other harmful effects ofthe sun.


Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn.

if used as directed with other sun protection measures (see Directions)decreases the risk of skin cancer and early skin agingcaused by the sun.

Dosage and Administration (34068-7)

Directions

·Applyliberally15 minutes before sun exposure·Reapply:·after 80 minutes of swimming orsweating·after towel drying, swimming, or·at least every 2 hours ·children under 6 months of age: ask a doctor.

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children.lf swallowed, getmedical help or contact Posion 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 of eyes.

Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 51727-6 (51727-6)

Water,Dimethicone, lsohexadecane, EthylhexylPalmitate, Butylene Glycol, Glycerin, lsopropyl PalmitateSorbitan Sesquioleate, Cetyl Peg/Ppg-10/ Dimethicone.Silica, Disteardimonium Hectorite, Sodium Chloride,Trimethylsiloxysilicate, Peg-30 Dipolyhydroxystearate,

Tribehenin, Magnesium Stearate, Phenoxyethanol,Triethoxycaprylylsilane Ethylhexylglycerin, PentaerythrityTetra-Di-T-Buty Hydroxyhydrocinnamate

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Please call:1-817-398-8817 or emus at [email protected].

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Zinc Oxide 4.85%

Titanium Dioxide 8%

Section 60561-8 (60561-8)

.Protect this product from excessive heat and direct sun.Sun alert: Limiting sunexposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer,and other harmful effects ofthe sun.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)