TRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMER cream

TRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMER by

Drug Labeling and Warnings

TRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMER by is a Otc medication manufactured, distributed, or labeled by MANA PRODUCTS, INC., MANA PRODUCTS, INC, MANA Products,INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Zinc Oxide 12.4%

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 damaged or broken skin. Stop use and ask doctor if rash occurs. When using, this product should be kept away from eye area. Rinse with water to remove.

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.

DIRECTIONS

Apply liberally 15 minutes before sun exposure. Use a water-resistant sunscreen if swimming or sweating. Reapply at least every 2 hours, Sun Protection Measures: Spending time in the sun increases risk of skin cancer and early 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 10:00 a.m. - 2:00 p.m. Wear long sleeved shirts, pants, hats and sunglasses. Children under 6 months: ask a doctor.

OTHER INFORMATION

PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN. MAY STAIN SOME FABRICS

INACTIVE INGREDIENTS

Water,C12-15 Alkyl Benzoate,Dimethicone,Argania Spinosa Kernel Oil,Tocopheryl Acetate,Cetearyl Alcohol,Propanediol,
Niacinamide,Polyhydroxystearic acid,Coco-Glucoside,Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer ,Glyceryl Stearate ,PEG-100 Stearate ,Silica ,Isohexadecane ,Pongamia Pinnata Seed Extract ,Xanthan Gum ,Bisabolol ,Citric Acid ,Hydroxyacetophenone ,Triethoxycaprylylsilane,Polysorbate 80,Polysilicone-11 ,Ethylhexylglycerin ,Trisodium Ethylenediamine Disuccinate ,Sodium Hydroxide ,Phenoxyethanol ,Yellow 5,Red 40

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMER 
traceless mineral broad spectrum spf sunscreen and primer cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59735-990
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	12.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
NIACINAMIDE (UNII: 25X51I8RD4)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
XANTHAN GUM (UNII: TTV12P4NEE)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
FD&C RED NO. 40 (UNII: WZB9127XOA)
DIMETHICONE 200 (UNII: RGS4T2AS00)
PROPANEDIOL (UNII: 5965N8W85T)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
COCO GLUCOSIDE (UNII: ICS790225B)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PEG-100 STEARATE (UNII: YD01N1999R)
ISOHEXADECANE (UNII: 918X1OUF1E)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
ARGAN OIL (UNII: 4V59G5UW9X)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59735-990-02	1 in 1 CARTON	06/12/2023
1	NDC: 59735-990-01	50 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 59735-990-04	1 in 1 CARTON	06/12/2023
2	NDC: 59735-990-03	50 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/12/2023

Labeler - MANA PRODUCTS, INC. (078870292)

Registrant - MANA PRODUCTS, INC (078870292)

Establishment
Name	Address	ID/FEI	Business Operations
MANA Products,INC		032870270	manufacture(59735-990)

Establishment
Name	Address	ID/FEI	Business Operations
MANA PRODUCTS, INC		078870292	manufacture(59735-990)