FDA.reportPublic FDA data

FACIAL SPF

Manufacturer
MAD HIPPIE LLC
Effective date
2020-03-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:39:05

Label at a glance#

ProductFACIAL SPF SPF-30
Active ingredientZINC OXIDE
Label structure9 sections

Indications and 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.

Dosage and administration

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...

Storage and handling

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT & SUNLIGHT.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

ZINC OXIDE (NON-NANO) 16%

PURPOSE

OTC - PURPOSE SECTION

SUNSCREEN

USES

INDICATIONS & USAGE SECTION

  • 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 SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT & SUNLIGHT.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MH_facial SPF NEWbox copyMH_facial SPF NEWbox copy

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73766-101-112024-03-27C16284748780-1d6a99b39-390b-a426-e053-dadaa90af4c25c59c350-4541-44f5-9048-7b2ab331ddd2
73766-101-112022-01-28C16284748780-1d6a99b39-390b-a426-e053-dadaa90af4c25c59c350-4541-44f5-9048-7b2ab331ddd2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73766-10173766-101-11

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
ALOE VERA LEAFZY81Z83H0XIACT
SHEA BUTTERK49155WL9YIACT
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETYL ALCOHOL936JST6JCNIACT
ORANGE OILAKN3KSD11BIACT
CARROT SEED OIL595AO13F11IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
ISOSTEARIC ACIDX33R8U0062IACT
JASMINUM OFFICINALE FLOWER0Q8K841432IACT
AVOCADO OIL6VNO72PFC1IACT
PHENYLETHYL ALCOHOLML9LGA7468IACT
POLYGLYCERYL-3 OLEATEXRQ165498BIACT
YELLOW WAX2ZA36H0S2VIACT
POLYGLYCERYL-6 DISTEARATEZ35I17EQOPIACT
RASPBERRY SEED OIL9S8867952AIACT
HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 40-44)AS2SZ9757NIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
HYALURONATE SODIUMYSE9PPT4THIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
14abf72b-ee9c-4eb3-e063-6294a90addf15c59c350-4541-44f5-9048-7b2ab331ddd22024-03-27WarningsExact identifier
spl set id: 5c59c350-4541-44f5-9048-7b2ab331ddd2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.