FDA.reportPublic FDA data

Daily SPF 30 Lotion

Manufacturer
Face Reality, Inc.
Effective date
2024-12-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:47:49

Label at a glance#

ProductDaily SPF 30
Active ingredientOCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONE
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 minites before sun expose Reapply at least 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 protecting measures including:  Limit time in the sun, expecially form 10 a.m. – 2 p.m. Wear long sleeve shirts, pants, hats and s...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octisalate 4.75% Oxybenzone 4.25% Octocrylene 2.8% Avobenzone 3% (UV-A)


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 if

OTC - STOP USE SECTION

  • rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minites before sun expose
  • Reapply at least 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 protecting measures including: 
  • Limit time in the sun, expecially form 10 a.m. – 2 p.m.
  • Wear long sleeve shirts, pants, hats and sunglasses
  • Children under 6 month: ask a doctor.

Other information

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylate/C 12-22 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.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle6Bottle6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70707-450-042024-01-30C16284748780-11030e365-270f-111a-e063-dadaa90a10e2Daily SPF 30 Lotion

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70707-450DAILY SPF 30 (OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONE) CREAM [FACE REALITY, INC.]4Legacy NDC20241205_7f05f7e4-153a-448a-be26-b66c4b9867b5.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70707-45070707-450-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 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
MACADAMIA OIL515610SU8CIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
PHENOXYETHANOLHIE492ZZ3TIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
EDETATE SODIUMMP1J8420LUIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT
OCTISALATE4X49Y0596WACTIB
OXYBENZONE95OOS7VE0YACTIB
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB

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
285f074c-1354-8e1c-e063-6394a90a369a7f05f7e4-153a-448a-be26-b66c4b9867b52024-12-03WarningsExact identifier
spl id: 285f074c-1354-8e1c-e063-6394a90a369a
spl set id: 7f05f7e4-153a-448a-be26-b66c4b9867b5

Reported adverse events (FAERS/openFDA)#

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