MINERAL DEFENSE SPORT CERAMIDE SPF-30- zinc oxide stick

MINERAL DEFENSE SPORT CERAMIDE by

Drug Labeling and Warnings

MINERAL DEFENSE SPORT CERAMIDE by is a Otc medication manufactured, distributed, or labeled by SOLARA SUNCARE, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Zinc Oxide 20%

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact Poison Control Center right away.

DIRECTIONS

keep out of direct heat or sunlight

apply generously and evenly 15 minutes before sun exposur

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 the risk, regularly use asunscreen 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-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

INACTIVE INGREDIENTS

Coco-Caprylate, Beeswax/Cera Alba, Jojoba Esters, Simmondsia Chinensis (Jojoba) Seed Oil, Helianthus Annus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Lauryl Laurate, Caprylic/Capric Triglyceride, Methyl Dihydroabietate, Stearyl/Octyldodecyl Citrate Crosspolymer, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Mangifera Indica (Mango) Seed Butter, Ceramide NG, Ceramide NP, Theobroma Cacao (Cocoa) Seed Butter, Glycine Soja (Soybean) Seed Extract, Silica, Glyceryl Caprylate, Glyceryl Undecylenate, Tocopherol

OTHER INFORMATION

• Protect this product from excessive heat and direct sun.

QUESTIONS OR COMMENTS

• 1-855-859-1600 (9am – 5pm ET)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MINERAL DEFENSE SPORT CERAMIDE  SPF-30
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73054-108
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: X323T6QO4M)
ISOSTEARIC ACID (UNII: X33R8U0062)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
CERAMIDE NG (UNII: C04977SRJ5)
CERAMIDE NP (UNII: 4370DF050B)
COCOA BUTTER (UNII: 512OYT1CRR)
SOYBEAN (UNII: L7HT8F1ZOD)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
TOCOPHEROL (UNII: R0ZB2556P8)
COCO-CAPRYLATE (UNII: 4828G836N6)
WHITE WAX (UNII: 7G1J5DA97F)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
CANDELILLA WAX (UNII: WL0328HX19)
LAURYL LAURATE (UNII: GPW77G0937)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73054-108-11	1 in 1 BOX	10/17/2021
1		28 g in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/17/2021

Labeler - SOLARA SUNCARE, INC. (040998319)