RADIABLOCK- oxybenzone, octinoxate 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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094 RadiaBlock Sunblock & LipBalm

Active ingredient

Oxybenzone 3%

Padimate O 7%

Purpose

Sunscreen

Sunscreen

Uses

Helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only.

Do not use

on broken or damaged skin

Stop use and ask a doctor

if rash occurs

When using this product

keep out of eyes. Rinse with water to remove.

Keep out of reach of children.

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

Directions

Apply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reaaply at least every 2 hours

Children under 6 months: Ask a doctor

Inactive ingredients

Aloe Barbadensis (Aloe Vera) Leaf Extract, Copernicia Cerifera (Carnauba) Wax, Flavor, Mineral Oil, Paraffin, Petrolatum, Retinyl Palmitate, Simmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol (Vitamin E), Zea Mays (Corn) Oil (and) BHA (and) Propyl Gallate (and) Citric Acid

Other information

Questions or comments?

1-800-MEDLINE (633-5463)

Monday-Friday, 9AM-5PM CST

Principal Display Panel

SPF 15 Lip Balm

NDC 53329-094-83

Carrington

RadiaBlock

Sunscreen SPF 15

Net Wt: .015 oz/4.2g

C:\Documents and Settings\gateway1\Desktop\53329-094 - Medline - RadiaBlock Lip Sunscreen Principal Display Panel
RADIABLOCK 
oxybenzone, octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-094
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE30 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
COCOA BUTTER (UNII: 512OYT1CRR)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
CORN OIL (UNII: 8470G57WFM)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MINERAL OIL (UNII: T5L8T28FGP)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PETROLATUM (UNII: 4T6H12BN9U)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
JOJOBA OIL (UNII: 724GKU717M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-094-834.2 g in 1 TUBE; Type 0: Not a Combination Product03/01/201304/30/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/201304/30/2025
Labeler - Medline Industries, LP (025460908)
Registrant - Medline Industries, LP (025460908)

Revised: 8/2023
Document Id: 032211ad-1f6c-64a1-e063-6294a90a0954
Set id: a82dbb9c-a101-4045-89f6-5def8096546e
Version: 5
Effective Time: 20230817
 
Medline Industries, LP