RADIABLOCK- oxybenzone and octinoxate lipstick 
Medline Industries, Inc.

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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Drug Facts

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 damaged or broken 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

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 Type HUMAN OTC DRUG Item Code (Source) NDC:53329-094
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 30 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
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)  
COCOA BUTTER (UNII: 512OYT1CRR)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
CORN OIL (UNII: 8470G57WFM)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53329-094-83 4.2 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 03/01/2013
Labeler - Medline Industries, Inc. (025460908)

Revised: 3/2013
Document Id: a82dbb9c-a101-4045-89f6-5def8096546e
Set id: a82dbb9c-a101-4045-89f6-5def8096546e
Version: 1
Effective Time: 20130301
 
Medline Industries, Inc.