Label: ACAIFUSION LIP BALM BROAD SPECTRUM SPF 30 SUPERGOOP- avobenzone, octinoxate, octisalate ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 75936-118-01, 75936-118-02 - Packager: SUPERGOOP LLC
- 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 March 25, 2022
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ACTIVE INGREDIENT
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 sweatingInactive 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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACAIFUSION LIP BALM BROAD SPECTRUM SPF 30 SUPERGOOP
avobenzone, octinoxate, octisalate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-118 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.44 g in 15 mL 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 Inactive Ingredients Ingredient Name Strength ASCORBYL PALMITATE (UNII: QN83US2B0N) SUNFLOWER OIL (UNII: 3W1JG795YI) ALOE VERA LEAF (UNII: ZY81Z83H0X) CASTOR OIL (UNII: D5340Y2I9G) D&C RED NO. 27 (UNII: 2LRS185U6K) COCONUT (UNII: 3RT3536DHY) PETROLATUM (UNII: 4T6H12BN9U) CERESIN (UNII: Q1LS2UJO3A) YELLOW WAX (UNII: 2ZA36H0S2V) POLYESTER-7 (UNII: 0841698D2F) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) CANDELILLA WAX (UNII: WL0328HX19) CARNAUBA WAX (UNII: R12CBM0EIZ) POLYSILICONE-15 (UNII: F8DRP5BB29) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) SHEA BUTTER (UNII: K49155WL9Y) HONEY (UNII: Y9H1V576FH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-118-02 1 in 1 BOX 06/28/2012 1 NDC:75936-118-01 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 06/28/2012 Labeler - SUPERGOOP LLC (117061743)
