MINERAL BABY UNSCENTED SPF 50 BROAD SPECTRUM- sunscreen lotion 
Bell International Laboratories, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Coola Mineral Baby SPF 50 Unscented Sunscreen Lotion

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

PDP

MINERAL BABY UNSCENTED  SPF 50 BROAD SPECTRUM
sunscreen lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76150-122
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7.3 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76150-122-1290 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2015
Labeler - Bell International Laboratories, Inc (967781555)

Revised: 10/2017
 
Bell International Laboratories, Inc