TINTED MINERAL SUNSCREEN SPF-30- titanium dioxide, zinc oxide lotion

TINTED MINERAL SUNSCREEN by

Drug Labeling and Warnings

TINTED MINERAL SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Buttah Enterprises, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

TITANIUM DIOXIDE 2.5%

ZINC OXIDE 6%

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 DAMAGE OR BROKEN SKIN.

WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

STOP USE AND ASK A DOCTOR IF RASH OCCURS.

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

• APPLY LIBERALLY AND EVENLY 15 MINUTES BEFORE SUN EXPOSURE
• REAPPLY AT LEAST EVERY 2 HOURS.
• USE A WATER-RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.
• 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 10 AM TO 2 PM.
•      WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.
•      CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.

INACTIVE INGREDIENTS

Water (Aqua), Caprylic/Capric Triglyceride, Cyclopentasiloxane, Propanediol, Dimethicone, Glycerin, C12-15 Alkyl Benzoate, PEG-100 Stearate, Glyceryl STearate, Cetyl Alcohol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glyceryl Caprylate, Cyclohexasiloxane, Sucrose Cocoate, Citric Acid, Sodium Citrate, Sodium PCA, Glyceryl Isostearate, Alumina, Caprylyl Methicone, Polyhydroxystearic Acid, Triethoxysilylethyl Polydimethylsiloxyethyl Dimethicone, Chlorphenesin, Iron Oxides, Allantoin, Xanthan Gum, Camellia Oleifera Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Glyceryl Undecylenate, Panthenol, Phytic Acid, Sodium Hyaluronate.

STORAGE AND HANDLING

CALL TOLL FREE:  1-800-428-8824

QUESTIONS OR COMMENTS

• call toll free:  1-833-428-8824

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TINTED MINERAL SUNSCREEN  SPF-30
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82069-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	6 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PROPANEDIOL (UNII: 5965N8W85T)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETYL ALCOHOL (UNII: 936JST6JCN)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
SUCROSE COCOATE (UNII: 3H18P0UK73)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ALUMINUM OXIDE (UNII: LMI26O6933)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
DIMETHICONE 100 (UNII: RO266O364U)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ALLANTOIN (UNII: 344S277G0Z)
XANTHAN GUM (UNII: TTV12P4NEE)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MATRICARIA RECUTITA FLOWERING TOP (UNII: 3VNC7T6Z02)
CUCUMBER (UNII: YY7C30VXJT)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
PANTHENOL (UNII: WV9CM0O67Z)
FYTIC ACID (UNII: 7IGF0S7R8I)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82069-101-12	60 mL in 1 TUBE; Type 0: Not a Combination Product	07/14/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/13/2021

Labeler - Buttah Enterprises, LLC. (117683150)