PER SOLE BY BRITTO LIP BALM SUNSCREEN BROAD SPECTRUM SPF 30- avobenzone, homosalate, octinoxate, octocrylene lipstick

Per Sole by Britto Lip Balm Sunscreen Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Per Sole by Britto Lip Balm Sunscreen Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by MR2 USA Corporation, PHARMATURA-INDUSTRIA DE COSMETICOS LTDA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Principal Display Panel - Statement of identity

Lip Balm Sunscreen Broad Spectrum SPF 30

Drug Facts Panel - Active Ingredients

Avobenzone 3.0% ----- Sunscreen

Homosalate 8.2% ----- Sunscreen

Octinoxate 7.5% ------- Sunscreen

Octocrylene 7.0% ----- Sunscreen

Drug Facts Panel - Purpose

Purpose: sunscreen

Drug Facts Panel - Use

Helps prevent sunburn.

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

Drug Facts Panel - Warnings

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. If swallowed get medical help or contact a Poison Control Center right away.

Drug Facts Panel - Warnings - Do not use

Do not use on damaged or broken skin.

Drug Facts Panel - Warnings - When using this product

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

Drug Facts Panel - Warnings - Stop use

Stop use and ask a doctor if rash occurs.

Drug Facts Panel - Warnings - Keep out of reach of children,

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Drug Facts Panel - Directions

Apply liberally 15 minutes before sun exposure.

Reapply at least every 2 hours.

Use a water-resistant sunscreen if swimming or sweating.

Children under 6 months of age: ask a doctor.

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 time in the sun, especially from 10 a.m.-2 p.m.  wear long-sleeved shirts, pants, hats, and sunglasses.

Drug Facts Panel - Other information

Protect the product in this container from excessive heat and direct sun.

Drug Facts Panel - Inactive ingredients

Beeswax, Butylated Hydroxytoluene, C12-15 Alkyl Benzoate, Carnauba Wax, Fragrance, Hydrogenated Vegetable Glycerides, Isopropyl Palmitate, Mineral Oil, Ozokerite, Paraffin, Synthetic Candellila Wax, Theobroma Cacao (Cocoa) Seed Butter.

Questions or comments

Contact weekdays from 9AM to 5PM at 1-305-646-1169.

Package Label - Principal Display Panel

NDC: 77069-001-01

Level 1 - cylinder (stick)

NDC: 77069-001-01

Level 2 - blister (3 x stick)

INGREDIENTS AND APPEARANCE

PER SOLE BY BRITTO LIP BALM SUNSCREEN BROAD SPECTRUM SPF 30 
avobenzone, homosalate, octinoxate, octocrylene lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77069-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8.2 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)	3 g  in 100 g
COCOA BUTTER (UNII: 512OYT1CRR)	8 g  in 100 g
CERESIN (UNII: Q1LS2UJO3A)	2.8 g  in 100 g
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)	0.05 g  in 100 g
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)	10 g  in 100 g
MINERAL OIL (UNII: T5L8T28FGP)	7 g  in 100 g
WHITE WAX (UNII: 7G1J5DA97F)	3 g  in 100 g
CARNAUBA WAX (UNII: R12CBM0EIZ)	6 g  in 100 g
PARAFFIN (UNII: I9O0E3H2ZE)	6.2 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77069-001-01	3 in 1 BLISTER PACK	07/23/2020
1		3.5 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/23/2020

Labeler - MR2 USA Corporation (080950597)

Establishment
Name	Address	ID/FEI	Business Operations
PHARMATURA-INDUSTRIA DE COSMETICOS LTDA		903405397	manufacture(77069-001) , pack(77069-001) , label(77069-001)