Active Ingredient

Active Ingredient: Zinc Oxide - 15.7% (non-nanoparticle)

Purpose

Purpose Sunscreen

Uses

• 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.

Warnings

Warnings For external use only

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

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

Other information Protect this product from excessive heat and direct sun.

Questions or Comments?

Questions or comments?

1-866-326-5477

ECO

LIPS

ZINC

SPF 30

BROAD SPECTRUM SPF 30

SUNSCREEN LOTION

UNSCENTED

NON-GREASY

WATER RESISTANT

(80 MINUTES)

Moisturizer with Aloe,

Shea Butter, and Cocoa Butter.

OXYBENZONE FREE

MANUFACTURED FOR

ECO LIPS, INC.

CEDAR RAPIDS, IA 52402

ECOLIPS.COM

Tube

ECO LIPS ZINC SPF 30 BROAD SPECTRUM SUNSCREEN UNSCENTED
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75071-415
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	15.7 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:75071-415-07	118.3 mL in 1 TUBE; Type 0: Not a Combination Product	06/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	06/01/2023

Labeler - Eco Lips, Inc. (138732727)