PROTECTIVE DAY- avobenzone, homosalate, octinoxate, octocrylene cream

Protective Day by

Drug Labeling and Warnings

Protective Day by is a Otc medication manufactured, distributed, or labeled by USANA Health Sciences, Inc., Universal Packaging Systems, Inc. (DBA Paklab). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octinoxate 7.5%

Octocrylene 2%

Purpose

Sunscreen

Uses

Helps Prevent Sunburn.

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

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.

(continued) Drug Facts

Directions:

Apply 2-3 pumps of product to face and neck

Apply generously and evenly 15 minutes before sun exposure

Reapply at least every 2 hours

Use a water-resistant sunscreen if swimming or sweating

. 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 value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10: a.m.–2:00 p.m. wear long-sleeved shirts, pants, hats, and sunglasses Sun Protection Measures

Children under 6 months of age: Ask a doctor

(continued) Drug Facts

Inactive Ingredients:

Water, Butylene Glycol, Tribehenin PEG-20 Esters, Isopropyl Lauroyl Sarcosinate, Pentylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isodecyl Neopentanoate, Cyclopentasiloxane, Ocimum Basilicum Hairy Root Culture Extract, Citrullus Lanatus (Watermelon) Fruit Extract, Olea Europaea (Olive) Fruit Extract*, Lens Esculenta (Lentil) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Glycine Soja (Soybean) Seed Extract, Acanthopanax Senticosus (Eleuthero) Root Extract, Panax Ginseng Root Extract, Panax Quinquefolius Root Extract, Butyrospermum Parkii (Shea) Butter, Ceramide NP, Rosa Multiflora Fruit Extract, Potassium Hydroxide, Sodium Lactate, Salicornia Herbacea Extract, Hydrolyzed Corn Starch, Sodium PCA, Diisopropyl Sebacate, Lauryl Lactate, Caprylic/Capric Triglyceride, Glycerin, Silica, Citric Acid, Fragrance.

Other Information

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

Questions or Comments?

Call toll free 1-800-950-9595

Package Labeling: 

INGREDIENTS AND APPEARANCE

PROTECTIVE DAY 
avobenzone, homosalate, octinoxate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51861-090
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9)
ISOPROPYL LAUROYL SARCOSINATE (UNII: LYR06W430J)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OCIMUM BASILICUM ROOT (UNII: 0ZW1H84PHV)
WATERMELON (UNII: 231473QB6R)
BLACK OLIVE (UNII: 2M6QWV94OC)
VICIA LENS FRUIT (UNII: ZYZ076G9JH)
APPLE (UNII: B423VGH5S9)
SOYBEAN (UNII: L7HT8F1ZOD)
ELEUTHERO (UNII: ZQH6VH092Z)
ASIAN GINSENG (UNII: CUQ3A77YXI)
AMERICAN GINSENG (UNII: 8W75VCV53Q)
SHEA BUTTER (UNII: K49155WL9Y)
CERAMIDE NP (UNII: 4370DF050B)
ROSA MULTIFLORA FRUIT (UNII: EZ5DSL4T27)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
SODIUM LACTATE (UNII: TU7HW0W0QT)
SALICORNIA EUROPAEA WHOLE (UNII: 6ADL50JAKW)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
LAURYL LACTATE (UNII: G5SU0BFK7O)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51861-090-00	1 in 1 CARTON	08/20/2024
1		28 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/20/2024

Labeler - USANA Health Sciences, Inc. (804413250)

Registrant - USANA Health Sciences, Inc. (804413250)

Establishment
Name	Address	ID/FEI	Business Operations
Universal Packaging Systems, Inc. (DBA Paklab)		177711082	manufacture(51861-090)