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.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3%
Homosalate 10%
Octinoxate 7.5%
Octocrylene 2%

Purpose

Sunscreen
Sunscreen
Sunscreen
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.

DOSAGE & ADMINISTRATION

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

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 value 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-sleeved shirts, pants, hats, and sunglasses
Children under 6 months of age: Ask a doctor

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,
Methyl Methacrylate Crosspolymer,
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: 51861-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 g  in 100 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)
WATERMELON (UNII: 231473QB6R)
BLACK OLIVE (UNII: 2M6QWV94OC)
LENS CULINARIS 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 (UNII: 6ADL50JAKW)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
LAURYL LACTATE (UNII: G5SU0BFK7O)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51861-050-00	1 in 1 CARTON	08/01/2017
1		28 g in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 51861-050-02	3 in 1 PACKAGE	08/01/2017
2		1 g in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 51861-050-01	15 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/01/2017

Labeler - USANA Health Sciences, Inc. (804413250)