SUN AND SHINE MINERAL SUNSCREEN- zinc oxide cream

SUN and SHINE MINERAL SUNSCREEN by

Drug Labeling and Warnings

SUN and SHINE MINERAL SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Peer Pharm Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Zinc Oxide 24.5%

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.
• When using this product, Keep out of eyes. Rinse with water to remove.
• Stop use and ask a doctor if rash or irritation develops and lasts.

Keep out of reach of children.

If swallowed, call a poison control center or get medical help right  away.

Directions

Apply liberally 15 minutes before sun exposure
Reapply:
after 40 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours
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 of 15 or higher and other sun protection measures including:
limit time in the sun, especially from 10 am to 2 p.m.
wear long-sleeve shirts, pants, hats, and sunglasses
Children under 6 months: ask a doctor

Other information

protect this product from excessive heat and sun

Inactive Ingredients

aqua, coco-caprylate, styrene/acrylates copolymer, octyldodecyl citrate crosspolymer, cetearyl olivate, sorbitan olivate, caprylyl glycol, glycerin, polyhydroxystearic acid, aloe barbadensis leaf juice, panthenol, triethoxycaprylylsilane, cetearyl alcohol, tocopherol, butyrospermum parkii (shea) butter, silica, silica dimethyl silylate, xanthan gum, caprylhydroxamic acid, propanediol, sodium phytate, dipotassium glycyrrhizate, chamomilla recutita (matricaria) flower extract, calendula officinalis flower extract, citric acid

Questions or Comments

Call 951-297-7976 or visit www.kcare.co.il

Product label

INGREDIENTS AND APPEARANCE

SUN AND SHINE MINERAL SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69435-1505
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	24.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
HEXASODIUM PHYTATE (UNII: ZBX50UG81V)
CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SHEA BUTTER (UNII: K49155WL9Y)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
XANTHAN GUM (UNII: TTV12P4NEE)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
DIPOTASSIUM GLUCOSE-6-PHOSPHATE (UNII: ZZW95F4360)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
COCO-CAPRYLATE (UNII: 4828G836N6)
SODIUM ACRYLATE/STYRENE SULFONATE COPOLYMER (11000 MW) (UNII: N30934870L)
ISOBUTANE (UNII: BXR49TP611)
WATER (UNII: 059QF0KO0R)
1-(ETHYLTRISULFANYL)PROPANE (UNII: 4SOS6O9G2X)
TRIOCTYLDODECYL CITRATE (UNII: 35X8CT063R)
ACRYLATES CROSSPOLYMER-4 (UNII: GEV2EL4D9G)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SORBITAN OLIVATE (UNII: MDL271E3GR)
CASTOR OIL (UNII: D5340Y2I9G)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL 1-PHOSPHATE (UNII: 48G71659RB)
CHAMOMILE (UNII: FGL3685T2X)
PANTHENOL (UNII: WV9CM0O67Z)
ALOE (UNII: V5VD430YW9)
1,4-BUTANEDITHIOL (UNII: 7JD227IUMC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69435-1505-1	1 in 1 CARTON	05/19/2022
1		50 mL 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	05/19/2022

Labeler - Peer Pharm Ltd. (514678390)

Registrant - Peer Pharm Ltd. (514678390)

Establishment
Name	Address	ID/FEI	Business Operations
Peer Pharm Ltd.		514678390	manufacture(69435-1505)