REMEDY LIP BALM- avobenzone, octinoxate, octisalate, octocrylene lipstick 
Medline Industries, LP

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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997 Remedy Lip Balm

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

Label

REMEDY LIP BALM 
avobenzone, octinoxate, octisalate, octocrylene lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-997
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.5 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
LIME OIL (UNII: UZH29XGA8G)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
ORANGE OIL (UNII: AKN3KSD11B)  
PEA PROTEIN (UNII: 7Q50F46595)  
CASTOR OIL (UNII: D5340Y2I9G)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
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)  
COMFREY LEAF (UNII: DG4F8T839X)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-997-214.25 g in 1 CONTAINER; Type 0: Not a Combination Product01/01/202006/30/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02001/01/202006/30/2023
Labeler - Medline Industries, LP (025460908)
Registrant - Medline Industries, LP (025460908)

Revised: 8/2023
 
Medline Industries, LP