ZINC OXIDE stick ZINC OXIDE lotion

Zinc Oxide by

Drug Labeling and Warnings

Zinc Oxide by is a Otc medication manufactured, distributed, or labeled by Hello Bello, Unconditional Love. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Zinc Oxide - 20.0%

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

WARNING:

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

• Reapply: After 80 minutes of swimming or sweating + immediately after towel drying
• At least every 2 hours
• For children under 6 months of age: 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: limited time in the sun, especially from 10 am. - 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses.

INACTIVE INGREDIENTS:

Helianthus Annuus (Sunflower) Seed Oil, Cocos Nucifera (Coconut) Oil*, Euphorbia Cerifera (Candelilla) Wax, Ricinus Communis (Castor) Seed Oil, Rubus Idaeus (Red Raspberry) Seed Oil, Butyrospermum Parkii (Shea) Butter*, Prunus Armeniaca (Apricot) Kernel Oil, Argania Spinosa (Argan) Kernel Oil*, Copernicia Cerifera (Carnauba) Wax*, Rosa Canina (Rosehip) Fruit Oil, Tocopherol - *Certified Organic

Principal Display Panel - 29 g Box Label

hello
bello

Mineral
Sunscreen
Stick

30
SPF

1.0 fl oz (29 g) e

Principal Display Panel - 29 g Stick Label

hello
bello

Mineral
Sunscreen
Stick

30
SPF

1.0 fl oz (29 g) e

Reef
Friendly

Vegan

Principal Display Panel - 88.7 mL Carton Label

50+
SPF

Broad Spectrum UVA + UVB Protection

Non- Nano Zinc Oxide

hello
bello™

Dermatologist Tested

Clinically Tested Non-Greasy

Hypoallergenic

Safe & Effective for
Adults & Kids

Mineral
Sunscreen

3.0 fl. oz. (88.7 ml) e

Reef
Friendly

Water Resistant
(80 Minutes)

INGREDIENTS AND APPEARANCE

ZINC OXIDE 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73418-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	22 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Sunflower Oil (UNII: 3W1JG795YI)
Coconut Oil (UNII: Q9L0O73W7L)
Candelilla Wax (UNII: WL0328HX19)
Castor Oil (UNII: D5340Y2I9G)
Raspberry Seed Oil (UNII: 9S8867952A)
Apricot Kernel Oil (UNII: 54JB35T06A)
Argan Oil (UNII: 4V59G5UW9X)
Carnauba Wax (UNII: R12CBM0EIZ)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Tocopherol (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73418-020-01	1 in 1 BOX	02/01/2019
1		29 mL 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 final	part352	02/01/2019

ZINC OXIDE 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73418-021
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	20 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Sunflower Oil (UNII: 3W1JG795YI)
Coconut Oil (UNII: Q9L0O73W7L)
Candelilla Wax (UNII: WL0328HX19)
Castor Oil (UNII: D5340Y2I9G)
Raspberry Seed Oil (UNII: 9S8867952A)
Apricot Kernel Oil (UNII: 54JB35T06A)
Argan Oil (UNII: 4V59G5UW9X)
Carnauba Wax (UNII: R12CBM0EIZ)
Rosa Canina Fruit Oil (UNII: CR7307M3QZ)
Tocopherol (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73418-021-01	88.7 mL in 1 TUBE; Type 0: Not a Combination Product	02/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/01/2019

Labeler - Hello Bello (081135707)

Establishment
Name	Address	ID/FEI	Business Operations
Unconditional Love		081135707	MANUFACTURE(73418-020, 73418-021)