TOTAL SUNCARE SUNSCREEN SPF 30 - avobenzone, octisalate, octinoxate, oxybenzone spray 
Total Suncare LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Sunscreen SPF 30

Active Ingredients

Avobenzone    3 percent
Octisalate       2 percent
Octinoxate      5 percent
Oxybenzone   3 percent


Purpose

Sunscreen

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

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.

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.

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.

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

Total SunCare
SUN
SCREEN
SPF 15

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

Total Suncare Sunscreen SPF 30

TOTAL SUNCARE SUNSCREEN SPF 30 
avobenzone, octisalate, octinoxate, oxybenzone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49893-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2 mL  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MINERAL OIL (UNII: T5L8T28FGP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49893-200-01177 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/25/2009
Labeler - Total Suncare LLC (831945980)
Establishment
NameAddressID/FEIBusiness Operations
Athena (Guangzhou) Cosmetics Manufacturer Co., Ltd527326663manufacture

Revised: 11/2009
Document Id: b07bf5e6-4502-438f-8ed5-a21e3f3ccbf7
Set id: fbf8f4a9-aaa4-4730-b2c5-a411f4179f13
Version: 1
Effective Time: 20091125
 
Total Suncare LLC