MINT FUSION LIP BALM SPF 30 SUPERGOOP- octinoxate, octisalate and avobenzone cream 
TAYLOR JAMES, LTD.

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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Mint Fusion Lip Balm

Active Ingredients Purpose

Avobenzone 3.0% Sunscreen

Ocinoxate 7.5% Sunscreen

Octisalate 5.0% Sunscreen

Helps prevent and temporarily protect 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

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. If swallowed, get medical help or contact a poison control center right away. If condition worsens or does not improve within 7 days, consult a doctor.

Directions

· Apply liberally 15 minutes before sun exposure

-Reapply liberally as often as necessary

· Use a water resistant sunscreen if swimming or sweating

· Children under 6 months: Ask a doctor

Reapply 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
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.

Inactive Ingredients- Petrolatum, Ozokerite, Beeswax, Polyester-7, Neopentyl Glycol Diheptanoate, Flavor, Sorbitan Oleate, Euphorbia Cerifera (Candelilla) wax, Copernicia cerifera (carnauba) Wax, Polysiilicone-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

image description

image description

Supergoop SPF 30

Soothe

Protect

Hydrate

MintFusion Lip Balm with Shea Butter

.50 Fl Oz

MINT FUSION LIP BALM SPF 30  SUPERGOOP
octinoxate, octisalate, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-113
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.11 g  in 14.79 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.74 g  in 14.79 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.44 g  in 14.79 mL
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V)  
CERESIN (UNII: Q1LS2UJO3A)  
CANDELILLA WAX (UNII: WL0328HX19)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
HONEY (UNII: Y9H1V576FH)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
POLYSILICONE-15 (UNII: F8DRP5BB29)  
TOCOPHEROL (UNII: R0ZB2556P8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MENTHONE 1,2-GLYCEROL KETAL, (-)- (UNII: 7V7GIB547Y)  
MENTHOL (UNII: L7T10EIP3A)  
SPEARMINT OIL (UNII: C3M81465G5)  
COCONUT OIL (UNII: Q9L0O73W7L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75936-113-0114.8 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/31/2012
Labeler - TAYLOR JAMES, LTD. (033381850)
Registrant - TAYLOR JAMES, LTD. (033381850)
Establishment
NameAddressID/FEIBusiness Operations
Cosway Company Inc620899877manufacture(75936-113)

Revised: 2/2015
Document Id: e61a8ef3-09b4-424f-8a70-f1e9dc0f36ae
Set id: 25f0dd2a-0465-49fb-ba11-f3596df2d968
Version: 4
Effective Time: 20150218
 
TAYLOR JAMES, LTD.