FDA.reportPublic FDA data

Sheer Face Cream

Manufacturer
Make2Give LLC
Effective date
2023-10-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:23:05

Label at a glance#

ProductSheer Face
Active ingredientZINC OXIDE
Label structure7 sections

Indications and uses

• helps prevent sunburn • Retains SPF after 80 minutes of swimming or sweating • 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

• Apply liberally and spread evenly 15 minutes before sun exposure and as needed. • Reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • 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 • li...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 15%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

• helps prevent sunburn

• Retains SPF after 80 minutes of swimming or sweating • 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.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop using and ask a doctor

OTC - STOP USE SECTION

if a rash or irritation develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or call a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Apply liberally and spread evenly 15 minutes before sun exposure and as needed. • Reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • 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 am- 2pm • wear long-sleeved shirts, pants, hats, and sunglasses




Sun  Protection Measures.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Bixa Orellana (Annatto) Extract, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Camellia Sinensis (Green Tea) Leaf Extract, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oil, Citrullus Lanatus (Watermelon) Extract, Daucus Carota Sativa (Carrot) Extract, Decyl Glucoside, Ethyl Vanillin, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Hippophae Rhamnoides (Sea Buckthorn) Oil, Hydroxyethylcellulose, Polyhydroxystearic Acid, Stearic Acid, Xanthan Gum, Zemea (Corn) Propanediol.

Other Information

SPL UNCLASSIFIED SECTION

Protect the product from excessive heat and direct sun.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label5Label5Label6Label6

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75796-00375796-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ANNATTO6PQP1V1B6OIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
SHEA BUTTERK49155WL9YIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CAPRYLYL GLYCOL00YIU5438UIACT
SAFFLOWER4VBL71TY4YIACT
WATERMELON231473QB6RIACT
CARROTL56Z1JK48BIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
ETHYL VANILLINYC9ST449YJIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
GLYCERYL 1-UNDECYLENATEB68LJT9544IACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
STEARIC ACID4ELV7Z65APIACT
XANTHAN GUMTTV12P4NEEIACT
CORN0N8672707OIACT
PROPANEDIOL5965N8W85TIACT
ZINC OXIDESOI2LOH54ZACTIM

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
287410ff-fa0e-5c5e-e063-6394a90ad292a85c5fba-afd0-40a8-9f0d-954669246ff82024-12-04WarningsExact identifier
spl set id: a85c5fba-afd0-40a8-9f0d-954669246ff8

Reported adverse events (FAERS/openFDA)#

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