MINERAL BABY SPF 50 BROAD SPECTRUM- sunscreen stick
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 SPF 50 Baby Sunscreen Stick

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

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 wtih a broad spectrum SPF of 15 or higher and other sun protection measures including:

limit 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

Beeswax (ORGANIC), Bisabolol, Butyrospermum Parkii (ORGANIC Shea Butter), Calophyllum Tacamahaca (ORGANIC Tamanu) Seed Oil, Chamomilla Recutita (ORGANIC Matricaria) Flower Extract, Cocos Nucifera (ORGANIC Coconut) Oil, Copernicia Cerifera (ORGANIC Carnauba) Wax, Helianthus Annuus (ORGANIC Sunflower) Seed Oil., Helianthus Annuus (ORGANIC Sunflower) Seed Wax, Jojoba Esters, Linum Usitatissimum (ORGANIC Linseed) Seed Oil, Ozokerite, Persea Gratissima (ORGANIC Avocado) Oil, Prunus Amygdalus Dulcis (ORGANIC Sweet Almond) Oil, Ricinus Communis (ORGANIC Castor) Seed Oil, Rubus Idaeus (ORGANIC Raspberry) Seed Oil, Sesamum Indicum (ORGANIC Sesame) Seed Oil, Simmondsia Chinensis (ORGANIC Jojoba) Seed Oil, Theobroma Cacao (ORGANIC Cocoa) Seed Butter, Tocopherol, Urtica Dioica (ORGANIC Nettle) Extract

Other information

protect this product from excessive heat and direct sun

may stain fabrics

PDP

MINERAL BABY SPF 50 BROAD SPECTRUM
sunscreen stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76150-210
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CERESIN (UNII: Q1LS2UJO3A)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SHEA BUTTER (UNII: K49155WL9Y)
URTICA DIOICA LEAF (UNII: X6M0DRN46Q)
COCONUT OIL (UNII: Q9L0O73W7L)
AVOCADO OIL (UNII: 6VNO72PFC1)
SESAME OIL (UNII: QX10HYY4QV)
RASPBERRY SEED OIL (UNII: 9S8867952A)
ALMOND OIL (UNII: 66YXD4DKO9)
CASTOR OIL (UNII: D5340Y2I9G)
JOJOBA OIL (UNII: 724GKU717M)
SUNFLOWER OIL (UNII: 3W1JG795YI)
YELLOW WAX (UNII: 2ZA36H0S2V)
COCOA BUTTER (UNII: 512OYT1CRR)
TOCOPHEROL (UNII: R0ZB2556P8)
CHAMOMILE (UNII: FGL3685T2X)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
CALOPHYLLUM TACAMAHACA SEED OIL (UNII: 05G85L61OE)
LINSEED OIL (UNII: 84XB4DV00W)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
LEVOMENOL (UNII: 24WE03BX2T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76150-210-39	29 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/01/2017	01/01/2021

Labeler - Bell International Laboratories, Inc. (967781555)

Revised: 1/2021

Document Id: b8dfa46c-ee66-effc-e053-2995a90a546e

Set id: 5d069775-9805-06e3-e053-2991aa0a7ee4

Version: 2

Effective Time: 20210114

Bell International Laboratories, Inc.