Face Reality (as PLD) - Daily SPF 30 Lotion (70707-450) - DELIST

Daily SPF 30 by

Drug Labeling and Warnings

Daily SPF 30 by is a Otc medication manufactured, distributed, or labeled by Face Reality, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DAILY SPF 30- octisalate, oxybenzone, octocrylene, avobenzone cream 
Face Reality, Inc.

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Face Reality (as PLD) - Daily SPF 30 Lotion (70707-450) - DELIST

Drug Facts

Active ingredients

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

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

Directions

• 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

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

Inactive ingredients

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:

DAILY SPF 30 
octisalate, oxybenzone, octocrylene, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70707-450
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	47.5 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	42.5 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	28 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

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)
MACADAMIA OIL (UNII: 515610SU8C)
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)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70707-450-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2016	12/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/20/2016	12/31/2023

Labeler - Face Reality, Inc. (602958071)

Revised: 3/2024

Document Id: 14ab5253-f2ad-8130-e063-6394a90a283b

34390-5

Set id: 7f05f7e4-153a-448a-be26-b66c4b9867b5

Version: 3

Effective Time: 20240327