FDA.reportPublic FDA data

Daily SPF30

Manufacturer
Face Reality Skin Care, LLC
Effective date
2024-12-03
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 20:47:47

Label at a glance#

ProductDaily SPF30
Active ingredientOXYBENZONE, OCTOCRYLENE, AVOBENZONE, OCTISALATE
Label structure7 sections

Indications and uses

• helps prevent sunburn • if used as directed with other sun protection measures (see  ), decreases the risk of skin cancer and early skin aging caused by the sun Directions

Dosage and administration

• apply liberally 15 minutes before sun exposure • reapply 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 a.m.–2 p.m. • wear long sleeve shirts, pants, hats, and sunglasses • ch...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Octisalate 4.75%

Oxybenzone 4.25%

Octocrylene 2.80%

Avobenzone 3.00%

Purpose

OTC - PURPOSE SECTION

Sunscreen

UV-A Sunscreen

Uses

INDICATIONS & USAGE SECTION

• helps prevent sunburn • if used as directed with other sun protection measures (see  ), decreases the risk of skin cancer and early skin aging caused by the sun
Directions

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

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

• apply liberally 15 minutes before sun exposure • reapply 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 a.m.–2 p.m. • wear long sleeve shirts, pants, hats, and sunglasses • children under 6 months: Ask a doctor.





Sun protection measures.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C12-22 Alkylmethacrylate Copolymer, Alerurites Moliccana Seed (Kukui Nut Oil), Allantoin, Butyloctyl Salicylate, Benzoic Acid, C12-C15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Cetearyl Alcohol, Cyclopentasiloxane, Dimethicone, Ethylhexylglycerin, Glycereth-2 Cocoate, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Macadamina (Nut) Ternifolia Seed Oil, Magnesium Aluminum Silicate, Phenoxyethanol, Polyacrylate Crosspolymer-6, Potassium Cetyl Phosphate, Tetrasodium Edta, Tocopheryl Acetate (Vitamin E Acetate),  Tocopherol, Water.

Other Information

SPL UNCLASSIFIED SECTION

• protect this product from excessive heat and direct sun

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70707-400-012024-01-30C16284748780-11030e365-66dd-111a-e063-dadaa90a10e2Daily SPF30

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70707-400DAILY SPF30 (OCTISALATE 4.75%, OXYBENZONE 4.25%, OCTOCRYLENE 2.80%, AVOBENZONE 3.005) CREAM [FACE REALITY SKIN CARE, LLC]8Legacy NDC20241205_3f2b463c-26a7-701f-e054-00144ff8d46c.zip

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
70707-40070707-400-01

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
KUKUI NUT OILTP11QR7B8RIACT
ALLANTOIN344S277G0ZIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
BENZOIC ACID8SKN0B0MIMIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DIMETHICONE92RU3N3Y1OIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERETH-2 COCOATEJWM00VS7HCIACT
GLYCERINPDC6A3C0OXIACT
SUNFLOWER OIL3W1JG795YIIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
PHENOXYETHANOLHIE492ZZ3TIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
WATER059QF0KO0RIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
EDETATE SODIUMMP1J8420LUIACT
TOCOPHEROLR0ZB2556P8IACT
OXYBENZONE95OOS7VE0YACTIB
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB

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
285efb0d-2b73-7a5c-e063-6394a90ae4873f2b463c-26a7-701f-e054-00144ff8d46c2024-12-03WarningsExact identifier
spl id: 285efb0d-2b73-7a5c-e063-6394a90ae487
spl set id: 3f2b463c-26a7-701f-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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