SUNPLUS SPF 50 EVERYDAY INSPIRED BROAD SPECTRUM SUNSCREEN- avobenzone, octisalate, octocrylene liquid

SunPlus SPF 50 Everyday Inspired Broad Spectrum Sunscreen by

Drug Labeling and Warnings

SunPlus SPF 50 Everyday Inspired Broad Spectrum Sunscreen by is a Otc medication manufactured, distributed, or labeled by SUNPLUS SKIN CARE LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENTS

Avobenzone 3.00%

Octisalate 5.00%

Octocrylene 10.00%

PURPOSE

Sunscreen

USES:

• Helps prevent sunburn.
• higher SPF gives more sunburn protection
• retains SPF after 40 minutes of swimming or sweating.
• 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 or irritation develops and lasts.

Keep out of reach of children.

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

If pregnant or breast-feeding,

ask a health professional before use

DIRECTIONS

• Apply liberally 15 minutes before sun exposure and as needed.
• Children under 6 months of age: ask a dcotor.
• Reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying 
• 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 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-sleeved shirts, pants, hats, and sunglasses.

OTHER INFORMATION

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

INACTIVE INGREDIENTS

Actinidia Chinensis (Kiwi) Fruit Extract, Aloe Barbadensis Leaf (Aloe Vera) Extract, Ascorbyl Palmitate (Vitamin C), Butyloctyl Salicylate, Carthamus Tinctorius (Safflower) Oil, Cocos Nucifera (Coconut) Oil, Garcinia Mangostana (Mangosteen) Extract, Glycerin, Helianthus Annuus (Sunflower) Oil, Hydrogenated Methyl Abietate, Linum Usitatissmum (Linseed) Oil, Lycium Barbarum (Goji) Fruit Extract, Parfum (Fragrance), Punica Granatum (Pomegranate) Extract, SD-Alcohol 40B, Tocopheryl Acetate (Vitamin E).

QUESTIONS?

info@sunplusca.com or sunplusca.com

Package Labelling:

INGREDIENTS AND APPEARANCE

SUNPLUS SPF 50 EVERYDAY INSPIRED BROAD SPECTRUM SUNSCREEN 
avobenzone, octisalate, octocrylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84661-523
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 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
KIWI FRUIT (UNII: 71ES77LGJC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SAFFLOWER (UNII: 4VBL71TY4Y)
COCONUT OIL (UNII: Q9L0O73W7L)
GLYCERIN (UNII: PDC6A3C0OX)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)
FLAX SEED (UNII: 4110YT348C)
POMEGRANATE (UNII: 56687D1Z4D)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84661-523-00	177 mL in 1 CAN; Type 0: Not a Combination Product	08/05/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/05/2024

Labeler - SUNPLUS SKIN CARE LLC (067298416)