IMPECCABLE SKIN SUNSCREEN FOUNDATION BROAD SPECTRUM SPF 30 SAND- zinc oxide cream

Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Sand by

Drug Labeling and Warnings

Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Sand by is a Otc medication manufactured, distributed, or labeled by Cosmetic Enterprises Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient.....Purpose

Zinc Oxide 15%......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. If swallowed, get medical help or contact a Poison Control Center right away.

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 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• children under 6 months: 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 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

INACTIVE INGREDIENT

Inactive Ingredients Aloe Barbadensis Leaf Juice, Purified Water, Caprylic/Capric Triglyceride, C13-15 Alkane, Glycerin, Lauroyl Lysine, Polyglyceryl-2 Oleate, Polyhydroxystearic Acid, C12-15 Alkyl Benzoate, Stearalkonium Hectorite, Leuconostoc/Radish Root Ferment Filtrate, Dipalmitoyl Hydroxyproline, Tetrahexyldecyl Ascorbate, Tocopherol, Sambucus Nigra Fruit Extract, Kappaphycus Alvarezii Extract, Caesalpinia Spinosa Fruit Extract, Melanin, Bisabolol, Hyaluronic Acid, Camellia Sinensis Leaf Extract, Phospholipids, Polyglyceryl-2 Stearate, Lactobacillus, Cocos Nucifera (Coconut) Fruit Extract, Ethylhexylglycerin, Sodium Chloride, Propylene Carbonate, Isopropyl Titanium, Triisostearate, Titanium Dioxide (C.I. 77891) Iron Oxides (C.I. 77492, C.I. 77491, C.I. 77499)

PRINCIPAL DISPLAY PANEL

Suntegrity

Impeccable Skin

Sunscreen Foundation

Broad Spectrum SPF 30

Non-Nano Zinc Oxide

Medium Coverage CC Cream Satin Finish

NET WT 2 OZ (56.7 g)

INGREDIENTS AND APPEARANCE

IMPECCABLE SKIN SUNSCREEN FOUNDATION BROAD SPECTRUM SPF 30 SAND 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56152-0258
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CAESALPINIA SPINOSA FRUIT EXTRACT (UNII: 2LBT8R6WE6)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
COCONUT (UNII: 3RT3536DHY)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-2 OLEATE (UNII: 5759J47SAM)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
LACTOBACILLUS (UNII: 5307V7XW8I)
ALOE BARBADENSIS LEAF JUICE (UNII: ZY81Z83H0X)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
KAPPAPHYCUS ALVAREZII EXTRACT (UNII: T479H08K2O)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
EUROPEAN ELDERBERRY (UNII: BQY1UBX046)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
LAUROYL LYSINE (UNII: 113171Q70B)
MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
C13-15 ALKANE (UNII: 114P5I43UJ)
TOCOPHEROL (UNII: R0ZB2556P8)
POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
BISABOLOL (UNII: 24WE03BX2T)
HYALURONIC ACID (UNII: S270N0TRQY)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56152-0258-1	7.1 g in 1 TUBE; Type 0: Not a Combination Product	10/24/2024
2	NDC: 56152-0258-2	56.7 g in 1 TUBE; Type 0: Not a Combination Product	10/24/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/24/2024

Labeler - Cosmetic Enterprises Ltd (017701475)