Label: ECO LIPS PLANTPOD SUNSCREEN LIP BALM SPORT SPF 30- avobenzone, octinoxate, octisalate, oxybenzone stick
- NDC Code(s): 75071-007-01, 75071-007-04
- Packager: Eco Lips. Inc.
- 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 June 7, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
- apply liberally 15 minutes before sun exposure
- reapply at least every 2 hours
- use a water-resistant sunscreen if swimming or sweating
- 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 value 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 of age: ask a doctor
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients
*Helianthus Annuus (Sunflower) Seed Oil, *Cera Flava (Beeswax), *†Theobroma Cacao (Cocoa) Seed Butter, *†Cocos Nucifera (Coconut) Oil, *Vanilla Flavor, *Aloe Barbadensis (Aloe Vera) Leaf Oil, Mixed Tocopherols (Vitamin E), *Rosmarinus Officinalis (Rosemary) Leaf Extract, *Calendula Officinalis (Calendula) Flower Extract.
* Certified Organic Ingredient † Fair Trade Certified™ by Fair Trade USA®. 20% of Product.
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- INDIVIDUAL TUBE LABEL
- BLISTER PACK CARTON PDP
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INGREDIENTS AND APPEARANCE
ECO LIPS PLANTPOD SUNSCREEN LIP BALM SPORT SPF 30
avobenzone, octinoxate, octisalate, oxybenzone stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75071-007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 4 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g Inactive Ingredients Ingredient Name Strength ROSEMARY OIL (UNII: 8LGU7VM393) ALOE VERA LEAF (UNII: ZY81Z83H0X) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) YELLOW WAX (UNII: 2ZA36H0S2V) SUNFLOWER OIL (UNII: 3W1JG795YI) COCOA BUTTER (UNII: 512OYT1CRR) TOCOPHEROL (UNII: R0ZB2556P8) COCONUT OIL (UNII: Q9L0O73W7L) Product Characteristics Color Score Shape Size Flavor VANILLA Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75071-007-04 4.25 g in 1 TUBE; Type 0: Not a Combination Product 03/01/2022 2 NDC:75071-007-01 1 in 1 BLISTER PACK 07/01/2022 2 4.25 g 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 M020 03/01/2022 Labeler - Eco Lips. Inc. (138732727) Establishment Name Address ID/FEI Business Operations Eco Lips, Inc. 138732727 manufacture(75071-007)
