BIG MOOD SPF 30 MILKY LIP BALM- zinc oxide stick

Big Mood SPF 30 Milky Lip Balm by

Drug Labeling and Warnings

Big Mood SPF 30 Milky Lip Balm by is a Otc medication manufactured, distributed, or labeled by Everyday Group Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Zinc Oxide 8%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see ) decreases the risk of skin cancer and early skin aging caused by the sun Directions

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

Stop use and ask a doctor

if rash occurs

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
• Use a water resistant sunscreen if swimming or sweating
• Reapply at least every 2 hours
•  Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measures:
• Limit time in the sun, especially from 10 a.m to 2 p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses
• Children under 6 months of age: Ask a doctor

Inactive Ingredients

Prunus Amygdalus Dulcis (Sweet Almond) Oil, Cera Alba (Beeswax), Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea) Butter, Euphorbia Cerifera (Candelilla) Wax, Flavor, Argania Spinosa Kernal (Argan) Oil, Caprylic/capric Triglyceride, Tocopheryl Acetate, Copernicia Cerifera (Carnauba) Wax, Avena Sativa Kernel (Oat) Oil, Agave Tequilana Stem Extract, Bisabolol, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Stevia Rebaudiana Extract, Glycine Soja (Soybean) Oil, Glyceryl Caprylate, Polyhydroxystearic Acid, Polyglyceryl-3-Polyricinoleate, Isostearic Acid, Lecithin, Glyceryl Undecylenta

Other Information

Protect the product in this container from excessive heat and direct sun. Store below 86°F/30°C

Package Labeling:

INGREDIENTS AND APPEARANCE

BIG MOOD SPF 30 MILKY LIP BALM 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72098-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	80 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
TRICAPRYLIN (UNII: 6P92858988)
ARGAN OIL (UNII: 4V59G5UW9X)
YELLOW WAX (UNII: 2ZA36H0S2V)
ALMOND OIL (UNII: 66YXD4DKO9)
JOJOBA OIL (UNII: 724GKU717M)
SHEA BUTTER (UNII: K49155WL9Y)
CANDELILLA WAX (UNII: WL0328HX19)
METHYL SALICYLATE (UNII: LAV5U5022Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARNAUBA WAX (UNII: R12CBM0EIZ)
OAT (UNII: Z6J799EAJK)
LEVOMENOL (UNII: 24WE03BX2T)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TOCOPHEROL (UNII: R0ZB2556P8)
SOYBEAN OIL (UNII: 241ATL177A)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
ISOSTEARIC ACID (UNII: X33R8U0062)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72098-004-01	1 in 1 CARTON	12/01/2021
1		4.2 g in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/01/2021

Labeler - Everyday Group Limited (664624682)