SPF ELIO DROPS 30 SHEER- zinc oxide cream

SPF Elio Drops 30 Sheer by

Drug Labeling and Warnings

SPF Elio Drops 30 Sheer by is a Otc medication manufactured, distributed, or labeled by Allure Labs Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS - ZINC OXIDE 15.6%

PURPOSE

PURPOSE...............SUNSCREEN

INDICATIONS & USAGE

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

WARNINGS FOR EXTERNAL USE ONLY

DO NOT USE

DISCONTINUE USE IF IRRITATION OR REDNESS OCCURS

WHEN USING

WHEN USING THIS PRODUCT KEEP OUT OF EYES. IF CONTACT OCCURS, RINSE WITH WATER.

STOP USE

STOP USE AND ASK A DOCTOR IF SEVERE IRRITATION OCCURS

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF THE REACH OF CHILDREN IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DOSAGE & ADMINISTRATION

DIRECTIONS FOR SUNSCREEN USE: APPLY GENEROUSLY 15 MINUTES BEFORE SUN EXPOSURE. APPLY TO ALL SKIN EXPOSED BY THE SUN. CHILDREN UNDER 6 MONTHS OF AGE: 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 VALUE OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING: LIMIT TIME IN SUN, ESPECIALLY FROM 10 A.M. - 2 P.M. WEAR LONG-SLEEVED SHIRTS, PANTS, HATS AND SUNGLASSES. REAPPLY AT LEAST EVERY 2 HOURS. USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING IMMEDIATELY AFTER TOWEL DRYING AT LEAST EVERY 2 HOURS.

OTHER SAFETY INFORMATION

OTHER INFORMATION:PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: ISODODECANE, SQUALANE, POLYSILICONE-11, PROPANEDIOL DICAPRYLATE/ CAPRATE, POLYHYDROXYSTEARIC ACID, POLYGLYCERYL-3 POLYRICINOLEATE, TRIETHOXYCAPRYLYLSILANE, TOCOPHERYL ACETATE, LECITHIN, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, TETRAHEXYLDECYL ASCORBATE, CAMELLIA OLEIFERA SEED OIL, PRUNUS ARMENIACA KERNEL OIL, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, ALOE BARBADENESIS LEAF EXTRACT, PISTACIA LENTISCUS (MASTIC) GUM OIL, ARGANIA SPINOSA KERNEL OIL, BISABOLOL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPF ELIO DROPS 30 SHEER 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4232
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	15.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ISODODECANE (UNII: A8289P68Y2)
ARGAN OIL (UNII: 4V59G5UW9X)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
LEVOMENOL (UNII: 24WE03BX2T)
SQUALANE (UNII: GW89575KF9)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
PISTACIA LENTISCUS RESIN OIL (UNII: ZJ39788YVA)
PROPANEDIOL DICAPRYLATE/CAPRATE (UNII: F53961BX4F)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SAFFLOWER OIL (UNII: 65UEH262IS)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GINGER (UNII: C5529G5JPQ)
CAMELLIA OIL (UNII: T1PE06G0VE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4232-2	1 in 1 CARTON	10/28/2023
1	NDC: 62742-4232-1	29.4 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	10/28/2023

Labeler - Allure Labs Inc (926831603)

Registrant - Allure Labs Inc (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs Inc		926831603	manufacture(62742-4232)