TOTAL SUNCARE SUNSCREEN SPF 50- avobenzone, homosalate, octinoxate, octisalate, oxybenzone spray

Total Suncare Sunscreen SPF 50 by

Drug Labeling and Warnings

Total Suncare Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Total Suncare LLC, Athena (Guangzhou) Cosmetics Manufacturer Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Avobenzone        3 percent
Homosalate        10 percent
Octinoxate          3 percent
Octyl Salicylate   3 percent
Oxybenzone        4 percent

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

Uses
- Helps prevent sunburn  
- Higher SPF gives more sunburn protection 
- Provides moderate protection against sunburn
- Retains SPF after 40 minutes of activity in the water

WARNINGS

Warnings
- For External Use Only
- Flammable: Keep away from fire or flame
- UV exposure from the sun increases the risk of skin cancer, premature skin aging,
  and other skin damage. It is important to decrease UV exposure by limiting time in
  the sun, wearing protective clothing, and using a sunscreen.
- 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
- Contents under pressure. Do not puncture or incinerate. Do not store at temperature
  above 120 degrees F.
- Keep out of reach of children.

INDICATIONS & USAGE

Directions
- Apply evenly before sun exposure and as needed.
- Hold can about 6in away from body and spray onto skin.
- Do not spray onto face - spray into palm and smooth over face and neck.
- Children under 6 months of age: ask a doctor.
- Reapply as needed or after towel drying, swimming, or perspiring.

USER SAFETY WARNINGS

Other Information
- Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may
  reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
- May stain some fabrics
- Avoid long term storage above 104 degrees F
- For your protection, this bottle has an imprinted seal around the neck. Do not use if
  tamper evident seal is missing, tampered, broken, or destroyed.

INACTIVE INGREDIENT

Acrylates / Octylacrylamide Copolymer, Alcohol Denat, Alkyl Benzoate, Aloe Barbadensis Leaf extract, Fragrance, Mineral oil

PRINCIPAL DISPLAY PANEL

Total SunCare
SUN
SCREEN
SPF 50

Contininous Spray
Water Resistant

BROAD SPECTRUM
UVA/UVB PROTECTION

Clear rub-free free formula
fast and easy coverage

Net Contents 6 fl oz (177 ml)

Expiration Date?

Lot Number?

Distributed By:
Total Suncare LLC, 100 S. Washington Ave.
Dunellen, NJ 08812, United States
www.sunscreenus.com

Product of China

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOTAL SUNCARE SUNSCREEN SPF 50 
avobenzone, homosalate, octinoxate, octisalate, oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49893-300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mL  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 mL  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49893-300-01	177 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/25/2009

Labeler - Total Suncare LLC (831945980)

Establishment
Name	Address	ID/FEI	Business Operations
Athena (Guangzhou) Cosmetics Manufacturer Co., Ltd		527326663	manufacture