Summer Camp Enviro UV Sunscreen Mist Broad Spectrum SPF 50

Summer Camp Enviro UV by

Drug Labeling and Warnings

Summer Camp Enviro UV by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUMMER CAMP ENVIRO UV BROAD SPECTRUM SPF 50- octisalate, avobenzone, homosalate spray 
Prime Enterprises Inc.

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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Summer Camp Enviro UV Sunscreen Mist Broad Spectrum SPF 50

Active Ingredients

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 5.0%

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.

Flammable: Do not use near heat, flame or while smoking.

Directions

• shake well before use
• hold container 4 to 6 inches from the skin to apply. Do not spray directly into face. Spray onto hands then apply to face. Do not breath msit in. Allow to fully dry.
• apply liberally 15 minutes beore sun exposure
• reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• Sun Protection Measures Spending time ine 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 valvue of 15 or higher and other sun protecion 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: Ask a doctor.

Other Information

Protect the product from excessive heat and direct sun.

INACTIVE INGREDIENTS

Ascorbyl Palmitate, Bisabolol, Camellia Oleifera (Green Tea) Leaf Extract, Fragrance, Glycerin, Polyester-8, Porphyra Umbilicalis Extract, SD Alcohol 40-B, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water​

Questions or Comments?

Call 800-217-8552

Summer Camp Enviro UV Facial Sunscreen Mist Broad spectrum SPF 50

SUMMER CAMP ENVIRO UV  BROAD SPECTRUM SPF 50
octisalate, avobenzone, homosalate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0554
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	26 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	43 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	86 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ASCORBYL PALMITATE (UNII: QN83US2B0N)
LEVOMENOL (UNII: 24WE03BX2T)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
ALCOHOL (UNII: 3K9958V90M)
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
ISOBORNYL ACRYLATE (UNII: IX0PRH184P)
DIBUTYL MALEATE (UNII: 4X371TMK9K)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
GLYCERIN (UNII: PDC6A3C0OX)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	yellow (Very Light Yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0554-3	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/08/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	06/08/2022

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc.		101946028	pack(58443-0554) , manufacture(58443-0554) , label(58443-0554) , analysis(58443-0554)

Revised: 8/2022

Document Id: e65df0f4-667a-6711-e053-2995a90a7161

34390-5

Set id: e65de9a6-2333-20db-e053-2995a90a83ce

Version: 1

Effective Time: 20220816