SPF30 SHEER TOUCH TINTED SUNSCREEN LIGHT - MEDIUM- zinc oxide lotion SPF30 SHEER TOUCH TINTED SUNSCREEN MEDIUM - DARK- zinc oxide lotion

SPF30 SHEER TOUCH TINTED SUNSCREEN by

Drug Labeling and Warnings

SPF30 SHEER TOUCH TINTED SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Andalou naturals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active ingredient

Zinc Oxide (21.5%)

Purpose

Sunscreen

Uses

Helps prevent sunburn

• if used as directed with other sun protection measures (see Directions) decreases the risk of early skin ageing caused by the sun.

Warnings

For external use only

• Do not use on damaged or broken skin
• Keep out of eyes. Rinse with water to remove

• Stop use and ask a doctor if a rash occurs

• Keep out of reach of children. If swallowed, get medical help or contact a poison control centre right away.

Directions

Apply liberally 15minutes before sun exposure

• reapply:
  • after swimming, sweating,
  • immediately after towel drying
  • every 2 hours
• Sun protection measures: Spending time in the sun increases your risk of skin cancer and early skin ageing. To decrease this risk regularly use a sunscreen with broad spectrum protection value of SPF15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10am to 2pm
  • wear long sleeved shirts, pants, hat and sunglasses.
  • children under 6 months of age ask a doctor.

Other information

Protect this product from excessive heat and direct sun

• may stain some fabrics.

Inactive ingredients

Aqua/Water/Eau, Isoamyl Laurate, Caprylic/Capric Triglyceride, Sorbitan Stearate, Cetearyl Alcohol, Hydroxypropyl Starch Phosphate, Phenethyl Alcohol, Caprylyl Glycol, Glyceryl Isostearate, Xanthan Gum, Polyhydroxystearic Acid, Cetearyl Glucoside, Sucrose Cocoate, Rosa Canina Fruit Oil, Carthamus Tinctorius (Safflower) Seed Oil, Glycerin, Cucumis Sativus (Cucumber) Fruit Extract, Camellia Sinensis Leaf Extract, Potassium Sorbate, Fragrance (Parfum), CI 77492, CI 77491, CI 77499.

Questions?

Call: AUS: 1300 858 898 CANADA: 1-888-464-6775

PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton - LIGHT - MEDIUM

sukin®
AUSTRALIAN NATURAL

SUNCARE

REEF SAFE
REEF SAFE

SPF30

SHEER TOUCH
TINTED
SUNSCREEN

UVA & UVB
BROAD SPECTRUM

LIGHT - MEDIUM

NO OXYBENZONE

60mL/2.03 fl oz

PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton - MEDIUM - DARK

sukin®
AUSTRALIAN NATURAL

SUNCARE

REEF SAFE
REEF SAFE

SPF30

SHEER TOUCH
TINTED
SUNSCREEN

UVA & UVB
BROAD SPECTRUM

MEDIUM - DARK

NO OXYBENZONE

60mL/2.03 fl oz

INGREDIENTS AND APPEARANCE

SPF30 SHEER TOUCH TINTED SUNSCREEN   LIGHT - MEDIUM
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55560-5002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	215 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
XANTHAN GUM (UNII: TTV12P4NEE)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
SUCROSE COCOATE (UNII: 3H18P0UK73)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
SAFFLOWER OIL (UNII: 65UEH262IS)
GLYCERIN (UNII: PDC6A3C0OX)
CUCUMBER (UNII: YY7C30VXJT)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55560-5002-1	1 in 1 CARTON	11/01/2020
1		60 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 FINAL	part347	10/08/2020

SPF30 SHEER TOUCH TINTED SUNSCREEN   MEDIUM - DARK
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55560-5003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	215 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
XANTHAN GUM (UNII: TTV12P4NEE)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
SUCROSE COCOATE (UNII: 3H18P0UK73)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
SAFFLOWER OIL (UNII: 65UEH262IS)
GLYCERIN (UNII: PDC6A3C0OX)
CUCUMBER (UNII: YY7C30VXJT)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55560-5003-1	1 in 1 CARTON	11/01/2020
1		60 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 FINAL	part347	10/08/2020

Labeler - Andalou naturals (011472720)