Label: MINT FUSION LIP BALM SPF 30 SUPERGOOP- octinoxate, octisalate, avobenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 75936-113-01, 75936-113-02 - Packager: TAYLOR JAMES, LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated November 12, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MINT FUSION LIP BALM SPF 30 SUPERGOOP
octinoxate, octisalate, avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-113 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.11 g in 15 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.74 g in 15 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.44 g in 15 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-113-02 1 in 1 CARTON 08/31/2012 1 NDC:75936-113-01 15 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/31/2012 Labeler - TAYLOR JAMES, LTD. (033381850) Registrant - TAYLOR JAMES, LTD. (033381850) Establishment Name Address ID/FEI Business Operations Cosway Company Inc 052400223 manufacture(75936-113)
