Label: ECO LIPS ZINC SPF 30 BROAD SPECTRUM SUNSCREEN UNSCENTED- zinc oxide lotion
- NDC Code(s): 75071-415-07
- 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 22, 2023
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- Active Ingredient
- Purpose
- Uses
- Warnings
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Directions
Directions
•Apply liberally 15 minutes before sun exposure.
• Reapply: • After 80 minutes of swimming or sweating. • Immediately after towel drying. • At least every 2 hours.
• Children under six months: Ask a doctor.
• 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 sun glasses. -
Inactive Ingredients
Inactive ingredients Aloe Barbadensis Leaf *, Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol*, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter*, Caprylhydroxamic Acid, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Coco-Glucoside, Cocos Nucifera (Coconut) Oil, Diheptyl Succinate, Glycerin, Microcrystalline Cellulose, Polyhydroxystearic Acid, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter*, Tocopherol, Water.
*Indicates Certified Organic
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INGREDIENTS AND APPEARANCE
ECO LIPS ZINC SPF 30 BROAD SPECTRUM SUNSCREEN UNSCENTED
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75071-415 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 15.7 g in 100 mL Inactive Ingredients Ingredient Name Strength COCONUT OIL (UNII: Q9L0O73W7L) GLYCERIN (UNII: PDC6A3C0OX) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) CETYL ALCOHOL (UNII: 936JST6JCN) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) SHEA BUTTER (UNII: K49155WL9Y) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) COCOA BUTTER (UNII: 512OYT1CRR) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) COCO GLUCOSIDE (UNII: ICS790225B) DIHEPTYL SUCCINATE (UNII: 057N7SS26Y) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) SODIUM GLUCONATE (UNII: R6Q3791S76) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TOCOPHEROL (UNII: R0ZB2556P8) WATER (UNII: 059QF0KO0R) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) DOCOSANOL (UNII: 9G1OE216XY) LEVOMENOL (UNII: 24WE03BX2T) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75071-415-07 118.3 mL in 1 TUBE; Type 0: Not a Combination Product 06/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 06/01/2023 Labeler - Eco Lips, Inc. (138732727)