Face Reality (as PLD) - Daily SPF30 (70707-400) - DELIST

Daily SPF30 by

Drug Labeling and Warnings

Daily SPF30 by is a Otc medication manufactured, distributed, or labeled by Face Reality Skin Care, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DAILY SPF30- octisalate 4.75%, oxybenzone 4.25%, octocrylene 2.80%, avobenzone 3.005 cream 
Face Reality Skin Care, LLC

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Face Reality (as PLD) - Daily SPF30 (70707-400) - DELIST

Drug Facts

Active Ingredient

Octisalate 4.75%

Oxybenzone 4.25%

Octocrylene 2.80%

Avobenzone 3.00%

Purpose

Sunscreen

UV-A Sunscreen

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

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 and 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

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

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

 protect this product from excessive heat and direct sun

Package Labeling:

DAILY SPF30 
octisalate 4.75%, oxybenzone 4.25%, octocrylene 2.80%, avobenzone 3.005 cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70707-400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.0425 g  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.028 g  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.03 g  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.0475 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
KUKUI NUT OIL (UNII: TP11QR7B8R)
ALLANTOIN (UNII: 344S277G0Z)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
BENZOIC ACID (UNII: 8SKN0B0MIM)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
WATER (UNII: 059QF0KO0R)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
EDETATE SODIUM (UNII: MP1J8420LU)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70707-400-01	62.5 g in 1 TUBE; Type 0: Not a Combination Product	05/03/2012	12/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/03/2012	12/31/2023

Labeler - Face Reality Skin Care, LLC (602958071)

Revised: 3/2024

Document Id: 14ab1296-271d-c3b5-e063-6294a90a70d4

34390-5

Set id: 3f2b463c-26a7-701f-e054-00144ff8d46c

Version: 7

Effective Time: 20240327