FACIAL SPF SPF-30- zinc oxide lotion

FACIAL SPF by

Drug Labeling and Warnings

FACIAL SPF by is a Otc medication manufactured, distributed, or labeled by MAD HIPPIE LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ZINC OXIDE (NON-NANO) 16%

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 & ASK A DOCTOR IF RASH OCCURS.

KEEP OUT OF REACH OF CHILDREN.

IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

PLEASE SHAKE WELL. APPLY LIBERALLY 15 MIN. BEFORE SUN EXPOSURE. RE-APPLY AFTER SWIMMING OR SWEATING, TOWEL DRYING, AND 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 A.M. - 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 & SUNLIGHT.

INACTIVE INGREDIENTS

ALOE BARBADENSIS LEAF JUICE, BUTYROSPERMUM PARKII (SHEA) BUTTER FRUIT, WATER, CAPRYLIC/CAPRIC TRIGLYCERIDES, CAPRYLYL GLYCOL, CETYL ALCOHOL, CITRUS SINENSIS (SWEET ORANGE) OIL, DAUCUS CAROTA SATIVA (CARROT) SEED OIL, ETHYLHEXYLGLYCERIN, GLYCERIN, ISOSTEARIC ACID, JASMINUM OFFICINALE (JASMINE) OIL, PERSEA GRATISSIMA (AVOCADO) OIL, PHENETHYL ALCOHOL, POLYGLYCERYL-3 BEESWAX, POLYGLYCERYL-6 DISTEARATE, RUBUS IDEAUS (RASPBERRY) SEED OIL, JOJOBA ESTERS, SODIUM ASCORBYL PHOSPHATE (VITAMIN C), SODIUM HYALURONATE, TOCOPHERYL (VITAMIN E)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FACIAL SPF  SPF-30
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73766-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	16 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SHEA BUTTER (UNII: K49155WL9Y)
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETYL ALCOHOL (UNII: 936JST6JCN)
ORANGE OIL (UNII: AKN3KSD11B)
CARROT SEED OIL (UNII: 595AO13F11)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
ISOSTEARIC ACID (UNII: X33R8U0062)
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
AVOCADO OIL (UNII: 6VNO72PFC1)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
POLYGLYCERYL-3 OLEATE (UNII: XRQ165498B)
YELLOW WAX (UNII: 2ZA36H0S2V)
POLYGLYCERYL-6 DISTEARATE (UNII: Z35I17EQOP)
RASPBERRY SEED OIL (UNII: 9S8867952A)
HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 40-44) (UNII: AS2SZ9757N)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73766-101-11	59 mL in 1 TUBE; Type 0: Not a Combination Product	03/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/19/2020

Labeler - MAD HIPPIE LLC (070869135)