ARNIES MINERAL SUNSCREEN - BROAD SPECTRUM SPF 50 WITH ZINC OXIDE- zinc oxide cream

Arnies Mineral Sunscreen - Broad Spectrum SPF 50 with Zinc Oxide by

Drug Labeling and Warnings

Arnies Mineral Sunscreen - Broad Spectrum SPF 50 with Zinc Oxide by is a Otc medication manufactured, distributed, or labeled by Gimmie Botanicals LLC, Royal Labs Natural Cosmetics Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 25%

PURPOSE

Sunscreen

USE

• Helps prevent sunburn if used as directed with other sun protection measures. See Directions below.
• May decreases the risk of skincancer 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
• If swallowed, get medical help or contact a Poison Control Center immediately.
• Stop use and consult a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

DIRECTIONS

• Apply liberal / 15 minutes before sun exposure.
• Reapply at least every two hours and immediately after towel drying.
• Use a water-resistant sunscreen if swimming or sweating.
• Consult a doctor before using with children under 6 months of age.
• 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 broad spectrum SPF value 15 or higher and other skin protection measures. These include limiting time in sun, especially from 10 am to 2 pm, and wearing long-sleeved shirts and pants, hats and sunglasses.

INACTIVE INGREDIENTS

Water, Simmondsia Chinensis (Jojoba) Oil, Helianthus Annuus (Sunflower) Oil, Glycerin, Dimethicone, Cetearyl Alcohol, Caprylic Capric Triglyceride, Squalane, Ceramide NP, Cetearyl Glucoside, Hyaluronic Acid, Bisabolol, Organic Aloe Barbadensis Leaf Juice, Niacinamide, Tocopherol, Panthenol, Allantoin, Triethoxycaprylylsilane, Caprylyl Glycol, Xanthan Gum, Phenoxyethanol, CI 77491, CI 77492, and CI 77499 Iron Oxides.

Arnies Mineral Sunscreen - Broad Spectrum SPF 50 with Zinc Oxide

INGREDIENTS AND APPEARANCE

ARNIES MINERAL SUNSCREEN - BROAD SPECTRUM SPF 50 WITH ZINC OXIDE 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87237-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CI 77499 (UNII: XM0M87F357)
WATER (UNII: 059QF0KO0R)
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL (UNII: 724GKU717M)
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL (UNII: 3W1JG795YI)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
SQUALANE (UNII: GW89575KF9)
CERAMIDE NP (UNII: 4370DF050B)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
HYALURONIC ACID (UNII: S270N0TRQY)
BISABOLOL (UNII: 24WE03BX2T)
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)
NIACINAMIDE (UNII: 25X51I8RD4)
TOCOPHEROL (UNII: R0ZB2556P8)
PANTHENOL (UNII: WV9CM0O67Z)
ALLANTOIN (UNII: 344S277G0Z)
CI 77491 (UNII: 1K09F3G675)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CI 77492 (UNII: EX438O2MRT)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87237-001-01	88 g in 1 TUBE; Type 0: Not a Combination Product	11/15/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/15/2025

Labeler - Gimmie Botanicals LLC (108481377)

Establishment
Name	Address	ID/FEI	Business Operations
Royal Labs Natural Cosmetics Inc.		197478480	manufacture(87237-001)