Summer Camp Enviro UV Sheer Sunscreen Mist Broad Spectrum SPF 30

Summer Camp Enviro UV by

Drug Labeling and Warnings

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

Drug Details [pdf]

SUMMER CAMP ENVIRO UV SPF 30 SUNSCREEN MIST- avobenzone, homosalate, octisalate spray 
Prime Packaging 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 Sheer Sunscreen Mist Broad Spectrum SPF 30

Active Ingredients

Avobenzone 3%

Homosalate 7.5%

Octisalate 5%

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.

Flammable: Contents under pressure. Do not puncture or incinerate. Do no store at temperatures above 120°F. Do not use in the presence of a flame or spark, or while smoking.

Do not use on damaged or broken skin.

When using this product keep away from face to avoid breathing it. Keep out of eyes. Rinse with water to remove.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Shake well
• Hold Container 4 to 6 inches from skin to apply.
• Apply liberally 15 minutes before sun exposure.
• Do not spray directly into face. Spray on hands then apply to face.
• Do not apply in windy condirions.
• Use in well-ventilated area.
• 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 a 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-sleeve shirts, pants, hats, and sunglasses.
• Children under 6 months: Ask a doctor

Other Information

• Protect this product from excessive heat and direct sun. Avoid spraying on fabrics - could cause discoloration

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Ascorbyl Palmitate, Bisabolol, Camellia Oleifera (Green Tea) Leaf Extract, Cucumis Sativus (Cucumber) Fruit Extract, Fragrance, Glycerin, Polyester-8, Porphyra Umbilicalis Extract, SD Alcohol 40-B, Sodium Hyaluronate, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water

Question or comments?

Call 800-217-8552

www.summercamplife.com

Summer Camp Enviro UV Sheer Sunscreen Mist Broad Spectrum SPF 30

SUMMER CAMP ENVIRO UV  SPF 30 SUNSCREEN MIST
avobenzone, homosalate, octisalate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13630-0246
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25.5 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	63.8 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	42.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
LEVOMENOL (UNII: 24WE03BX2T)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
GLYCERIN (UNII: PDC6A3C0OX)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALCOHOL (UNII: 3K9958V90M)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)
WATER (UNII: 059QF0KO0R)
DIBUTYL MALEATE (UNII: 4X371TMK9K)
VINYL ACETATE (UNII: L9MK238N77)
ISOBORNYL ACRYLATE (UNII: IX0PRH184P)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CUCUMBER (UNII: YY7C30VXJT)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13630-0246-4	200 mL in 1 CAN; 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 Packaging Inc. (805987059)

Registrant - Prime Packaging Inc. (805987059)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc		101946028	manufacture(13630-0246) , analysis(13630-0246)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Packaging Inc.		805987059	pack(13630-0246) , label(13630-0246)

Revised: 8/2022

Document Id: e64ea74b-473f-cdba-e053-2995a90ad36d

34390-5

Set id: e64e9f9a-0940-d173-e053-2995a90ae5df

Version: 1

Effective Time: 20220815