ILLUMINATING SPF 50 PLUS DROPS BROAD SPECTRUM SUNSCREEN- zinc oxide lotion

Illuminating SPF 50 plus drops Broad Spectrum Sunscreen by

Drug Labeling and Warnings

Illuminating SPF 50 plus drops Broad Spectrum Sunscreen by is a Otc medication manufactured, distributed, or labeled by Cosmetic Enterprise Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient Purpose

Zinc Oxide........ ....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 is rash occurs

WARNINGS

Warnings

For external use only

When using this product keep out of eyes, rinse with water to remove.

DOSAGE & ADMINISTRATION

Directions

• Shake well before use
• Apply liberally 15 minutes before sun exposure
• Reapply
• After 80 minutes of swimming or sweating
• immediately after towel drying
• Sun Protection Meaures. Spending time under the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regurlarly use a sunscreen with an SPF of 15 or higher, and other sun protection meaures, including:
• limit time under the sun, especially from 10:00 a.m. to 2:00 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months of age: ask doctor

INACTIVE INGREDIENT

Inactive Ingredients

C13-15 Alkane, Aqua/water/Eau, Ethyl Macadamiate, Caprylic/Capric Triglyceride, Polyhydroxystearic Acid, Propanediol, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Polyglyceryl-3 Polyricinoleate, Ectoin, Hydroxyectoin, Isostearic acid, Lecithin, Trisodium Ethylenediamine Disuccinate, Quaternium-90 Bentonite, Fragrance/Parfum, Citrus Aurantium Dulcis (Orange) Peel Oil, Triethyl Citrate, Tocopherol, Malic Acid, Stearyl Triethoxysilane, Sodium Chloride, Ethylhexylglycerin, Phenoxyethanol, Iron Oxide (CI 77491), Iron Oxide (CI 77492), Iron Oxide (CI 77499)

OTHER SAFETY INFORMATION

Other Information

Protect the product from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

Kate Somerville

Mineral SPF 50+

Hydrakate

Illuminating SPF 50+ Drops

Broad Spectrum Sunscreen

Water Resistant (80 Minutes)

50 mL 1.7 Fl. Oz

INGREDIENTS AND APPEARANCE

ILLUMINATING SPF 50 PLUS DROPS BROAD SPECTRUM SUNSCREEN 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56152-0253
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
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ECTOINE (UNII: 7GXZ3858RY)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
TOCOPHEROL (UNII: R0ZB2556P8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ISOSTEARIC ACID (UNII: X33R8U0062)
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
QUATERNIUM-90 BENTONITE (UNII: 97K5YEF88C)
STEARYL TRIETHOXYSILANE (UNII: 1VN9P25L8H)
C13-15 ALKANE (UNII: 114P5I43UJ)
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
HYDROXYECTOIN (UNII: CIJ7YN252E)
MALIC ACID (UNII: 817L1N4CKP)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56152-0253-1	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/22/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/22/2024

Labeler - Cosmetic Enterprise Ltd (017701475)