MINERAL SPORT GOLDEN TINT 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 SPF 50 Mineral Sport Stick Golden Tint

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 thisproduct keep out of eyes. Rinse with water to remove.

Stop use and ask doctor if skin rash occurs

Warnings

Keep out of reach of choldren. 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:

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

children under 6 months: Ask a doctor

Inactive Ingredients

Beeswax (ORGANIC), Bisabolol, Butyrospermum Parkii (ORGANIC Shea Butter), Calophyllum Tacamahaca (ORGANIC Tamanu) Seed Oil, Cocos Nucifera (ORGANIC Coconut) Oil, Copernicia Cerifera (ORGANIC Carnauba) Wax, Flavor, Helianthus Annuus (ORGANIC Sunflower) Seed Oil, Helianthus Annuus (Sunflower) Seed Wax, Iron Oxides, Jojoba Esters, Laminaria Digitata Extract, Linum Usitatissimum (ORGANIC Linseed) Seed Oil, Octyldodecanol, Octyldodecyl Oleate, Ozokerite, Persea Gratissima (ORGANIC Avocado) Oil, Prunus Amygdalus Dulcis (ORGANIC Sweet Almond) Oil, Ricinus Communis (ORGANIC Castor) Seed Oil, Rubus Ideaus (ORGANIC Raspberry) Seed Oil. Salvia Officinalis Leaf Extract (ORGANIC), Sesamum Indicum (ORGANIC Sesame) Seed Oil, Simmondsia Chinensis (ORGANIC Jojoba) Seed Oil, Theobroma Cacao (ORGANIC Cocoa) Seed Butter, Tocopherol, Trihydroxystearin

Other information

Protect this product from excessive heat and direct sun

may stain fabrics

PDP

MINERAL SPORT GOLDEN TINT SPF 50 BROAD SPECTRUM
sunscreen stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76150-208
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
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ALMOND OIL (UNII: 66YXD4DKO9)
OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)
COCONUT OIL (UNII: Q9L0O73W7L)
AVOCADO OIL (UNII: 6VNO72PFC1)
SHEA BUTTER (UNII: K49155WL9Y)
LEVOMENOL (UNII: 24WE03BX2T)
JOJOBA OIL (UNII: 724GKU717M)
RASPBERRY SEED OIL (UNII: 9S8867952A)
YELLOW WAX (UNII: 2ZA36H0S2V)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
LAMINARIA HYPERBOREA (UNII: NXA595GQ1K)
SESAME OIL (UNII: QX10HYY4QV)
LINSEED OIL (UNII: 84XB4DV00W)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CALOPHYLLUM TACAMAHACA SEED OIL (UNII: 05G85L61OE)
CERESIN (UNII: Q1LS2UJO3A)
CARNAUBA WAX (UNII: R12CBM0EIZ)
OCTYLDODECANOL (UNII: 461N1O614Y)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CASTOR OIL (UNII: D5340Y2I9G)
COCOA BUTTER (UNII: 512OYT1CRR)
TOCOPHEROL (UNII: R0ZB2556P8)
SAGE (UNII: 065C5D077J)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76150-208-39	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: b8df9bad-ddce-6d41-e053-2a95a90ace4d

Set id: 5cc873cc-1732-7a5d-e053-2a91aa0a4e08

Version: 2

Effective Time: 20210114

Bell International Laboratories, Inc.