SPF 30 MINERAL SUNSCREEN- titanium dioxide, zinc oxide cream 
Malin and Goetz 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.

----------

(Malin+Goetz) SPF 30 mineral Sunscreen

Active Ingredient Purpose

Titanium Dioxide 3.71% Sunscreen

Zinc Oxide 2.71% Sunscreen

Uses

Keep out of reach of children

Stop use and ask a doctor

Warnings: For external use only

Do not use on damaged or broken skin

When using this product

Directions

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 your time in the sun, especially from 10a.m. – 2 p.m.

Inactive ingredients

Water/Aqua/Eau, Glycerin, Caprylic/Capric Triglyceride, Butyrospermum Parkii (Shea) Butter, Niacinamide, Coconut Alkanes, Alumina, Glycogen, Isohexadecane, Polysorbate 60, Sorbitan Isostearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sodium Hyaluronate, Diethylhexyl Syringlidenemalonate, Triethoxycaprylylsilane, Ursolic Acid, Stearic Acid, Polyhydroxystearic Acid, hydrogenated Lecithin, Benzyl Alcohol, Phenoxyethanol, Tocopheryl Acetate, Coco-Caprylate/Caprate, Aminomethyl Propanol, Xanthan Gum, Citric Acid.

(Malin+Goetz)

spf 30 mineral sunscreen

Broad Spectrum

Water-Resistant 40 minutes

1.7 fl.oz./50 ml

carton spf 30 mineral sunscreen

Tube spf 30 mineral

SPF 30 MINERAL SUNSCREEN 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53634-128
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.71 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.71 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SHEA BUTTER (UNII: K49155WL9Y)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
URSOLIC ACID (UNII: P3M2575F3F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
GLYCERIN (UNII: PDC6A3C0OX)  
COCONUT ALKANES (UNII: 1E5KJY107T)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
WATER (UNII: 059QF0KO0R)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
NIACINAMIDE (UNII: 25X51I8RD4)  
GLYCOGEN (UNII: 309GSC92U1)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53634-128-0150 mL in 1 TUBE; Type 0: Not a Combination Product12/15/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02012/15/2022
Labeler - Malin and Goetz Inc (138615930)

Revised: 2/2023
Document Id: f3d39df9-1619-7014-e053-2995a90af7bb
Set id: f3d39df9-1618-7014-e053-2995a90af7bb
Version: 1
Effective Time: 20230203
 
Malin and Goetz Inc