REMEDY LIP BALM- avobenzone, octinoxate, octisalate, octocrylene lipstick

Remedy Lip Balm by

Drug Labeling and Warnings

Remedy Lip Balm by is a Otc medication manufactured, distributed, or labeled by Medline Industries, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone (2.0%)

Octinoxate (6.5%)

Octisalate (5.0%)

Octocrylene (1.5%)

Purpose

Sunscreen

Uses

• helps prevent sunburn
• higher SPF gives more sunburn protection

Warnings

For external use only.

Do not use

on damaged or broken skin

Stop use and ask a doctor if

rash or irritation develops and lasts

Keep out of reach of children.

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

When using this product

• keep out of eyes. Rinse with water to remove.

Directions

• apply liberally 15 minutes before sun exposure and as needed
• use water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including limiting time in the sun, especially from 10am-2pm. Wear long sleeved shirts, pants, hats and sunglasses.

Inactive ingredients

aloe barbadensis leaf juice, arnica montana flower extract, beeswax*, butyrospermum parkii (shea) butter*, calendula officinalis flower extract*, citrus aurantifolia (lime) oil, citrus aurantium dulcis (orange) peel oil, citrus limon (lemon) peel oil, citris paradisi (grapefruit) peel oil, copernicia cerifera (carnauba) wax*, euphorbia cerifera (candelilla) wax, helianthus annuus (sunflower) seed oil, mangifera indica (mango) seed butter, persea gratissima (avocado) oil*, pisum sativum (pea) protein, prunus armeniaca (apricot) kernel oil*, ricinus communis (castor) seed oil*, rubus idaeus (raspberry) leaf extract*, salix alba (willow) bark extract, symphytum officinale leaf extract, tocopherol, vitis vinifera (grape) seed oil*, zingiber officinale (ginger) root oil*. *Certified Organic Ingredient - Contains No Animal Fats - Gluten Free

Other information

protect this product from excessive heat and direct sun

Package Label

INGREDIENTS AND APPEARANCE

REMEDY LIP BALM 
avobenzone, octinoxate, octisalate, octocrylene lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-997
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
COMFREY LEAF (UNII: DG4F8T839X)
TOCOPHEROL (UNII: R0ZB2556P8)
GRAPE SEED OIL (UNII: 930MLC8XGG)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
LIME OIL (UNII: UZH29XGA8G)
ORANGE OIL (UNII: AKN3KSD11B)
PEA PROTEIN (UNII: 7Q50F46595)
CASTOR OIL (UNII: D5340Y2I9G)
SALIX ALBA BARK (UNII: 205MXS71H7)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GINGER OIL (UNII: SAS9Z1SVUK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
YELLOW WAX (UNII: 2ZA36H0S2V)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
LEMON OIL (UNII: I9GRO824LL)
CANDELILLA WAX (UNII: WL0328HX19)
SUNFLOWER OIL (UNII: 3W1JG795YI)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
AVOCADO OIL (UNII: 6VNO72PFC1)
SHEA BUTTER (UNII: K49155WL9Y)
GRAPEFRUIT OIL (UNII: YR377U58W9)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
RUBUS IDAEUS LEAF (UNII: 8O2V33JG64)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-997-21	4.25 g in 1 CONTAINER; Type 0: Not a Combination Product	01/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/01/2020

Labeler - Medline Industries, Inc. (025460908)

Establishment
Name	Address	ID/FEI	Business Operations
Bentley Laboratories, LLC		068351753	manufacture(53329-997)