MINERAL SUNSCREEN LIP BALM SPF 15- titanium dioxide, zinc oxide lipstick

Mineral Sunscreen Lip Balm SPF 15 by

Drug Labeling and Warnings

Mineral Sunscreen Lip Balm SPF 15 by is a Otc medication manufactured, distributed, or labeled by Aruba Aloe Balm NV. 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 Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

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 generously 15 minutes before sun exposure.
• reapply
• after 80 minutes of swimming or sweating.
• immediately after towel drying.
• at least every 2 hours.
• 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.

Other Information

• protect the product in this container from excessive heat and direct sun.

Inactive ingredients

Petrolatum, Theobroma Cacoa (Cocoa) Seed Butter, Euphorbia Cerifera (Candelilla) Wax, Beeswax, Cocos Nucifera (Coconut) Oil, Sorbitan Oleate, Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Tocopheryl Acetate (Vitamin E Acetate).

Package Labeling:

INGREDIENTS AND APPEARANCE

MINERAL SUNSCREEN LIP BALM SPF 15 
titanium dioxide, zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53675-184
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
PETROLATUM (UNII: 4T6H12BN9U)
COCOA (UNII: D9108TZ9KG)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
COCONUT (UNII: 3RT3536DHY)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53675-184-17	4.8 g in 1 APPLICATOR; Type 0: Not a Combination Product	01/05/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/05/2019

Labeler - Aruba Aloe Balm NV (855442273)