MINERAL BABY UNSCENTED SPF 50 BROAD SPECTRUM- sunscreen lotion

Mineral Baby Unscented by

Drug Labeling and Warnings

Mineral Baby Unscented by is a Otc medication manufactured, distributed, or labeled by Bell International Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Titanium Dioxide 7.3%

Zinc Oxide 4.3%

Purpose

Sunscreen

Uses

helps prevent sunburn

if used as idrected 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 doctor if skin rash occurs

Keep out of reach of children. If product is 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

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 of 15 or higher and other sun protection measures including:

• llimit time in the sun, especially from 10am-2pm
• wear long-sleeve shirts, pants, hats and sunglasses

Children under 6 monts: Ask a doctor

Inactive ingredients

Aloe Barbadensis Leaf Extract (ORGANIC), Beeswax (ORGANIC), Bisabolol, Butyrospermum Parkii (ORGANIC Shea Butter), Carthamus Tinctorius (Safflower) Oleosomes, Cocos Nucifera (ORGANIC Coconut) Oil, Copernicia Cerifera (ORGANIC Carnauba) Wax, Jojoba Esters, Oryzanol, Persea Gratissima (ORGANIC Avocado) Oil, Sesamum Indicum (ORGANIC Sesame) Seed Oil, Silica, Theobroma Cacao (ORGANIC Cocoa) Seed Butter, Tocopherol, Water

Other information

protect this product from excessive heat and direct sun

natural product dispenses best above 67 F/19 C

PDP

INGREDIENTS AND APPEARANCE

MINERAL BABY UNSCENTED  SPF 50 BROAD SPECTRUM
sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76150-122
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	7.3 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
COCONUT OIL (UNII: Q9L0O73W7L)
AVOCADO OIL (UNII: 6VNO72PFC1)
SESAME OIL (UNII: QX10HYY4QV)
SOYBEAN OIL (UNII: 241ATL177A)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
CARNAUBA WAX (UNII: R12CBM0EIZ)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
COCOA BUTTER (UNII: 512OYT1CRR)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
TOCOPHEROL (UNII: R0ZB2556P8)
LEVOMENOL (UNII: 24WE03BX2T)
GAMMA ORYZANOL (UNII: SST9XCL51M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76150-122-12	90 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2015

Labeler - Bell International Laboratories, Inc (967781555)