Label: ECO SPF30 SUN STICK- spf30 broad spectrum sun stick stick
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Contains inactivated NDC Code(s)
NDC Code(s): 58418-274-05 - Packager: Tropical Enterprises International, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 February 3, 2020
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INSTRUCTIONS FOR USE
Directions
- apply liberally 15 minutes before sun exposure.
- reapply:
- after 40 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 with a 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-sleeved shirts; pants, hats and sunglasses
- children under 6 months: Ask a doctor.
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INACTIVE INGREDIENT
Inactive Ingredients
*Aloe Barbadenis (Aloe Vera) Leaf Oil, *Cera Flava (Beeswax), *Calendula Officinalis (Calendula) Flower Extract, *Cocos Nucifera (Cocounut) Oil, "Hellanthus Annuus (Sunflower) Seed Oil, *Rosmarinus Officinalis (Rosemary) Leaf Extract, *Theeobroma Cacao (Cocoa) Seed Butter, Mixed Tocopherols (Vitamin E).
*Organic Ingredients
- OTHER SAFETY INFORMATION
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ECO SPF30 SUN STICK
spf30 broad spectrum sun stick stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58418-274 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 4 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L) SUNFLOWER OIL (UNII: 3W1JG795YI) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) COCONUT OIL (UNII: Q9L0O73W7L) APIS CERANA WORKER SECRETION (UNII: PRG8653U8K) COCOA BUTTER (UNII: 512OYT1CRR) TOCOPHEROL (UNII: R0ZB2556P8) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58418-274-05 15 mL in 1 CANISTER; Type 0: Not a Combination Product 08/27/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/01/2014 Labeler - Tropical Enterprises International, Inc (091986179) Registrant - Tropical Enterprises International, Inc. (091986179) Establishment Name Address ID/FEI Business Operations Tropical Enterprises International, Inc. 091986179 label(58418-274)
