MINERAL TINTED SPF 30- titanium dioxide, zinc oxide lotion

MINERAL TINTED SPF 30 by

Drug Labeling and Warnings

MINERAL TINTED SPF 30 by is a Otc medication manufactured, distributed, or labeled by BOTANICAL SCIENCE, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

TITANIUM DIOXIDE 2.5%

ZINC OXIDE 6.0%

PURPOSE

SUNSCREEN

USES

HELPS PREVENT SUNBURN.

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 a doctor if rash occurs.

DIRECTIONS

APPLY GENEROUSLY 15 MINUTES BEFORE SUN EXPOSURE. REAPPLY AT LEAST EVERY 2 HOURS. IF SWIMMING OR SWEATING, USE A WATER-RESISTANT SUNSCREEN. FOR CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR.

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 VALUE OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING: LIMIT TIME IN THE SUN, ESPECIALLY FROM 10AM - 2PM, WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INACTIVE INGREDIENTS

AQUA, CAPRYLIC/CAPRIC TRIGLYCERIDE, CYCLOPENTASILOXANE, PROPANEDIOL, GLYCERIN, C12-15 ALKYL BENZOATE, DIMETHICONE, GLYCERYL STEARATE, PEG-100 STEARATE, CETYL ALCOHOL, SODIUM HYALURONATE, SODIUM PCA, PHYTIC ACID, CAMELLIA OLEIFERA LEAF EXTRACT, CHAMOMILLA RECUTITA FLOWER EXTRACT, CUCUMIS SATIVUS FRUIT EXTRACT, IRON OXIDES, CYCLOHEXASILOXANE, GLYCERYL CAPRYLATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, SUCROSE COCOATE, CITRIC ACID, GLYCERYL ISOSTEARATE, POLYHYDROXYSTEARIC ACID, SODIUM CITRATE, CAPRYLYL METHICONE, ALUMINA, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, CHLORPHENESIN, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, ALLANTOIN, XANTHAN GUM, GLYCERYL UNDECYLENATE, PANTHENOL, POLYSORBATE 60, SORBITAN ISOSTEARATE, PHENOXYETHANOL.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MINERAL TINTED SPF 30 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70712-104
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
CHAMOMILE (UNII: FGL3685T2X)
SUCROSE COCOATE (UNII: 3H18P0UK73)
POLYSORBATE 60 (UNII: CAL22UVI4M)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PHYTIC ACID (UNII: 7IGF0S7R8I)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINA (UNII: LMI26O6933)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
IRON OXIDES (UNII: 1K09F3G675)
CUCUMIS SATIVUS (CUCUMBER) FRUIT (UNII: YY7C30VXJT)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)
ALLANTOIN (UNII: 344S277G0Z)
PANTHENOL (UNII: WV9CM0O67Z)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
SODIUM PCA (UNII: 469OTG57A2)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETYL ALCOHOL (UNII: 936JST6JCN)
WATER (UNII: 059QF0KO0R)
PEG-100 STEARATE (UNII: YD01N1999R)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
CITRIC ACID (UNII: 2968PHW8QP)
PROPANEDIOL (UNII: 5965N8W85T)
CAPRYLYL METHICONE (UNII: Q95M2P1KJL)
CHLORPHENESIN (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70712-104-11	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/04/2025
2	NDC: 70712-104-12	472 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/04/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/04/2025

Labeler - BOTANICAL SCIENCE, INC. (783654275)