LIP BALM SPF30 CVS- avobenzone 2.00% homosalate 15.00% octisalate 5.00% octinoxate 7.50% stick
CVS

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 ingredients Purpose

Avobenzone - 2.00%                       Sunscreen
Homosalate - 15.00%                      Sunscreen
Octisalate - 5.00%                           Sunscreen
Octinoxate – 7.50%                         Sunscreen

Uses • Helps prevent sunburn

Warnings
For external use only

Do not use on damage or broken skin

When using this productkeep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of the children
If product is swallowed, get medical help or contact a Poison Control Center right away

Directions

• apply liberally 15 minutes before sun exposure
• reapply:
   - after 80 minutes of swimming or sweating
   - immediately after towel drying
   - at least every 2 hours
• 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 SPF of 15 or higher and other sun protection measures including:
   - limit time in the sun, especially from 10 a.m. – 2 p.m.
   - wear long sleeve shirts, pants, hats, and sunglasses
• children under 6 month: Ask a doctor

Inactive ingredients

Ascorbyl Palmitate, Beeswax, Benzyl Alcohol, BHT, Candelilla Wax, Ethylhexyl Palmitate, Flavor, Helianthus Annuus (Sunflower) Seed Oil,Persea Gratissima (Avocado) Oil, Polyester-8, Retinyl Palmitate, Ricinus Communis (Castor) Seed Oil, Saccharin, Simmondsia Chinensis , (Jojoba) Seed Oil, Tocopheryl Acetate

Other information

• protect this product from excessive heat and direct sun • may stain fabrics

image description

LIP BALM SPF30 CVS
avobenzone 2.00% homosalate 15.00% octisalate 5.00% octinoxate 7.50% stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-034
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	Avobenzone	2 g in 100 g
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	15 g in 100 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	5 g in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	7.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
Ascorbyl Palmitate (UNII: QN83US2B0N)
YELLOW WAX (UNII: 2ZA36H0S2V)
Benzyl Alcohol (UNII: LKG8494WBH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
Candelilla Wax (UNII: WL0328HX19)
Ethylhexyl Palmitate (UNII: 2865993309)
SUNFLOWER OIL (UNII: 3W1JG795YI)
AVOCADO OIL (UNII: 6VNO72PFC1)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CASTOR OIL (UNII: D5340Y2I9G)
JOJOBA OIL (UNII: 724GKU717M)
Saccharin (UNII: FST467XS7D)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69842-034-01	1 in 1 CARTON	04/02/2018
1		4 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	02/17/2014	04/02/2018

Labeler - CVS (062312574)

Registrant - Product Quest Mfg (927768135)

Name	Address	ID/FEI	Business Operations
Establishment
Product Quest Mfg		927768135	manufacture(69842-034) , label(69842-034)

Revised: 4/2018

Document Id: 93dc586b-00aa-4b58-ba06-6af90452205f

Set id: 1fe56320-37f4-46c3-8a8f-9fe3aaefe3b3

Version: 3

Effective Time: 20180426