Medication Guide App

SUN DEFENSE SPF 30

Dosage form: lotion
Ingredients: AVOBENZONE 25mg in 1mL, OCTINOXATE 75mg in 1mL, OXYBENZONE 6mg in 1mL, TITANIUM DIOXIDE 20mg in 1mL
Labeler: Kamins Dermatologics Inc.
NDC Code: 63550-851

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.

SUN DEFENSE SPF30 CONSUMER LABELING

Active ingredients:

Avobenzone 2.5%

Octinoxate 7.5%

Oxybenzone 6%

Titanium dioxide 2%

Purpose: Sunscreen

Keep out of reach of children.

This oil and fragrance-free broad spectrum UVA/UVB sunscreen provides important protection against the sun’s harmful rays. Recommended for use on face and body, for everyday wear and outdoor activities. This cosmetically elegant formula is non-greasy, leaves a matte finish, and can be reapplied over makeup.

• fragrance-free • oil-free
• for face and body

Uses

■ Helps prevent sunburn.

■ Higher SPF gives more sunburn protection.

■ Provides high protection against sunburn.

Warnings

For external use only.

When using this product, keep out of eyes. If contact occurs, rinse abundantly with water to remove.

Stop use and ask a doctor if rash or irritation develops and lasts.

If swallowed, seek medical assistance or contact a Poison Control Center immediately.


Other information

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Store at room temperature 15-30°C (59-86°F).

Directions

■ Apply liberally and evenly to face and exposed areas 15-30 minutes before sun exposure.

■ Reapply every two hours or as needed.

■ Reapply after swimming, towel drying, washing or perspiring heavily.

Children under 6 months of age: ask a doctor.

Inactive ingredients: water, octyldodecyl neopentanoate, propylene glycol, acer saccharum, tocopheryl acetate, cetyl alcohol, stearic acid, DEA-cetyl phosphate, panthenol, dimethicone, xanthan gum, carbomer, sodium hydroxide, phenoxyethanol, chlorphenesin, BHT, iron oxides (CI 77491).

SUN DEFENSE SPF 30

120 mL / 4 fl. oz

DIN 02241810

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SUN DEFENSE SPF 30 
avobenzone octinoxate oxybenzone titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63550-851
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE25 mg  in 1 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE75 mg  in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE6 mg  in 1 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
OCTYLDODECYL NEOPENTANOATE 
PROPYLENE GLYCOL 
ACER SACCHARUM SAP 
.ALPHA.-TOCOPHEROL ACETATE, D- 
CETYL ALCOHOL 
STEARIC ACID 
DIETHANOLAMINE CETYL PHOSPHATE 
PANTHENOL 
DIMETHICONE 
XANTHAN GUM 
SODIUM HYDROXIDE 
PHENOXYETHANOL 
CHLORPHENESIN 
BUTYLATED HYDROXYTOLUENE 
FERRIC OXIDE RED 
Packaging
#Item CodePackage Description
1NDC:63550-851-10120 mL in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/02/2011
Labeler - Kamins Dermatologics Inc. (254050784)
Registrant - Kamins Dermatologics Inc. (254050784)
Establishment
NameAddressID/FEIOperations
Kamins Dermatologics Inc.254050784manufacture, pack, label

Revised: 09/2011
 
Kamins Dermatologics Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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