Acaifusion Lip Balm Broad Spectrum SPF 30 Supergoop

Dosage form: ointment
Ingredients: AVOBENZONE 0.44g in 14.79mL, OCTINOXATE 1.11g in 14.79mL, OCTISALATE 0.74g in 14.79mL
Labeler: TAYLOR JAMES, LTD.
NDC Code: 75936-118

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.

Acaifusion Lip Balm Broad Spectrum SPF 30

Active Ingredients                                                    Purpose

Avobezone 3%, Octinoxate 7.5%, Octisalate 5%     Sunscreen

Uses

-Helps prevent and temporarily chafed,chapped, cracked, or windburned skin and/or lips.
-helps prevent sunburn
-If used as directed with other sun protection measures (see Directions),
decreases the risk of skin cancer and early skin aging caused by the sun

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

· Stop use and ask a doctor if rash occurs

Warnings

· For external use only
· Do not use on damaged or broken skin
· When using this product keep out of eyes. Rinse with water to remove.

Directions


- Apply liberally 15 minutes before sun exposure
- Reapply Liberally as often as necessary.
- 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 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
- Reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating

Inactive Ingredients-Petrolatum, Ozokerite, Beeswax, Polyester-7, Neopentyl Glycol Diheptanoate, Flavor, Sorbitan Oleate, Euphorbia Cerifera (Candelilla) Wax, Polysilicone-15, Glycine Soja (Soybean) Oil, Tocopherol, Butyrospermum Parkii (Shea) Butter, Honey, Ascorbyl Palmitate, Helianthus Annuus (Sunflower) Seed Oil, Aloe Barbadensis Leaf Extract, Ricinus Communis (Castor) Seed Oil, Red 27 Lake, Cocos Nucifera (Coconut) Fruit Extract

Doctor T's Supergoop

SPF 30

Acaifusion Lip Balm

with Shea butter

Broad Spectrum SPF 30

.50 fl. oz.

ACAIFUSION LIP BALM BROAD SPECTRUM SPF 30  SUPERGOOP
avobenzone, octinoxate, octisalate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-118
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE0.44 g  in 14.79 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE1.11 g  in 14.79 mL
OCTISALATE (OCTISALATE) OCTISALATE0.74 g  in 14.79 mL
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
CERESIN 
YELLOW WAX 
POLYESTER-7 
NEOPENTYL GLYCOL DIHEPTANOATE 
SORBITAN MONOOLEATE 
CANDELILLA WAX 
CARNAUBA WAX 
POLYSILICONE-15 
SOYBEAN OIL 
TOCOPHEROL 
SHEA BUTTER 
HONEY 
ASCORBYL PALMITATE 
SUNFLOWER OIL 
ALOE VERA LEAF 
CASTOR OIL 
D&C RED NO. 27 
COCONUT 
Packaging
#Item CodePackage Description
1NDC:75936-118-0114.79 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/28/2012
Labeler - TAYLOR JAMES, LTD. (033381850)
Registrant - TAYLOR JAMES, LTD. (033381850)
Establishment
NameAddressID/FEIOperations
Cosway Company Inc.620899877manufacture(75936-118)

Revised: 02/2014
 
TAYLOR JAMES, LTD.

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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