MINERAL SUN DEFENSE MOISTURIZER BROAD SPECTRUM SUNSCREEN SPF 30- titanium dioxide, zinc oxide paste

Mineral Sun Defense Moisturizer Broad Spectrum Sunscreen SPF 30 by

Drug Labeling and Warnings

Mineral Sun Defense Moisturizer Broad Spectrum Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by June Jacobs Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Titanium Dioxide................4.31%

Zinc Oxide .......................19.27%

PURPOSE

Sunscreen

INDICATIONS & USAGE

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 cause by the sun.

WARNINGS

Warnings For external use only

DO NOT USE

Do not use on damaged or broken skin

WHEN USING

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 swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

Apply liberally 15 minutes before sun exposure

Reapply every 2 hours

Use a water resistant sunscreen if swimming or sweating

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 10 a.m.- 2 p.m.

wear long sleeved shirts, pants, hats and sunglasses

OTHER SAFETY INFORMATION

Other information Protect the product in this container from excessive heat and direct sun

INACTIVE INGREDIENT

Inactive ingredients

Ethyl Macadamiate, Caprylic/Capric Triglyceride, Saccharomyces Ferment, Coco-Caprylate/Caprate, Behenyl Behenate, Sorbitol/ Sebacic Acid Copolymer Behenate, Polyhydroxystearic Acid, Octyldodecyl Erucate, Euphorbia Cerifera (Candelilla) Wax, Fragrance/Parfum, Lauroyl Lysine, Iron Oxides, Stearic Acid, Alumina, Glyceryl Caprylate, Butyrospermum Parkii (Shea) Butter, Persea Gratissima (Avocado) Oil , Argania Spinosa Kernel Oil, Tocopheryl Acetate, Polyglyceryl-6 Polyricinoleate, Dilinoleic Acid/Butanediol Copolymer, Tocopherol, Glyceryl Undecylenate, Malic Acid, Castor Oil/IPDI Copolymer, Glycerin, Lycium Barbarum Fruit Extract , Punica Granatum Extract, Vitis Vinifera (Grape) Seed Extract, Aspalathus Linearis Leaf Extract , Leuconostoc/Radish Root Ferment Filtrate, Camellia Sinensis Leaf Extract, Limonene, Linalool, Citral.

QUESTIONS

Questions or comments? Call toll free 1-866-586-3522

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MINERAL SUN DEFENSE MOISTURIZER BROAD SPECTRUM SUNSCREEN SPF 30 
titanium dioxide, zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65278-619
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.169 g  in 50.28 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	9.693 g  in 50.28 g

Inactive Ingredients
Ingredient Name	Strength
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)
ORANGE OIL (UNII: AKN3KSD11B)
LAUROYL LYSINE (UNII: 113171Q70B)
ARGAN OIL (UNII: 4V59G5UW9X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)
AVOCADO OIL (UNII: 6VNO72PFC1)
TOCOPHEROL (UNII: R0ZB2556P8)
ALUMINUM OXIDE (UNII: LMI26O6933)
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)
OCTYLDODECYL ERUCATE (UNII: D4N66T98C2)
SUNFLOWER OIL (UNII: 3W1JG795YI)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
AMYRIS BALSAMIFERA OIL (UNII: I1BJ961J2E)
VETIVER OIL (UNII: 9M9P32M01L)
STEARIC ACID (UNII: 4ELV7Z65AP)
SHEA BUTTER (UNII: K49155WL9Y)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
MALIC ACID (UNII: 817L1N4CKP)
CASTOR OIL (UNII: D5340Y2I9G)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
GALBANUM (UNII: C690YC9N2Z)
DILINOLEIC ACID/BUTANEDIOL COPOLYMER (UNII: 1F2S8T535O)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
CANDELILLA WAX (UNII: WL0328HX19)
LAVANDIN OIL (UNII: 9RES347CKG)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)
CITRAL (UNII: T7EU0O9VPP)
LITSEA OIL (UNII: 2XIW34BN6O)
POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO)
GINGER OIL (UNII: SAS9Z1SVUK)
ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
BEHENYL BEHENATE (UNII: K8NU647RJ0)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
JUNIPER BERRY OIL (UNII: SZH16H44UY)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)

Product Characteristics
Color	brown (Nude/Beige)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65278-619-01	50.28 g in 1 TUBE; Type 0: Not a Combination Product	09/08/2021
2	NDC: 65278-619-02	50.28 g in 1 CARTON; Type 0: Not a Combination Product	09/08/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/08/2021

Labeler - June Jacobs Labs, LLC (082439410)