SPF 30 MINERAL SUNSCREEN- titanium dioxide, zinc oxide cream

spf 30 mineral Sunscreen by

Drug Labeling and Warnings

spf 30 mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by Malin and Goetz Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient Purpose

Titanium Dioxide 3.71% Sunscreen

Zinc Oxide 2.71% Sunscreen

PURPOSE

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

INDICATIONS & USAGE

Stop use and ask a doctor

• if rash occurs

WARNINGS

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

DOSAGE & ADMINISTRATION

Directions

• Apply liberally and evenly 15 minutes before sun exposure
• 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 your time in the sun, especially from 10a.m. – 2 p.m.

• wear long-sleeved shirts, pants, hats, and sunglasses
• reapply after 40 minutes of swimming or sweating
• Immediately after towel drying
• At least every 2 hours

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

(Malin+Goetz)

spf 30 mineral sunscreen

Broad Spectrum

Water-Resistant 40 minutes

1.7 fl.oz./50 ml

INGREDIENTS AND APPEARANCE

SPF 30 MINERAL SUNSCREEN 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53634-128
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.71 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.71 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53634-128-01	50 mL in 1 TUBE; Type 0: Not a Combination Product	12/15/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	12/15/2022

Labeler - Malin and Goetz Inc (138615930)