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NDC 13630-0246-04 Summer Camp Enviro UV 25.5; 63.8; 42.5 mg/mL; mg/mL; mg/mL Details

Summer Camp Enviro UV 25.5; 63.8; 42.5 mg/mL; mg/mL; mg/mL

Summer Camp Enviro UV is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Prime Packaging Inc.. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE.

Product Information

NDC	13630-0246
Product ID	13630-0246_e64ea74b-473f-cdba-e053-2995a90ad36d
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Summer Camp Enviro UV
Proprietary Name Suffix	SPF 30 Sunscreen Mist
Non-Proprietary Name	Avobenzone, Homosalate, Octisalate
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	25.5; 63.8; 42.5
Active Ingredient Units	mg/mL; mg/mL; mg/mL
Substance Name	AVOBENZONE; HOMOSALATE; OCTISALATE
Labeler Name	Prime Packaging Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	M020
Listing Certified Through	2024-12-31

Package

Package Images

NDC 13630-0246-04 (13630024604)

Pricing Information	N/A
NDC Package Code	13630-0246-4
Billing NDC	13630024604
Package	200 mL in 1 CAN (13630-0246-4)
Marketing Start Date	2022-06-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e64e9f9a-0940-d173-e053-2995a90ae5df Details

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

INGREDIENTS AND APPEARANCE

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13630-0246-4	200 mL in 1 CAN; Type 0: Not a Combination Product	06/08/2022

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

Labeler - Prime Packaging Inc. (805987059)

Registrant - Prime Packaging Inc. (805987059)

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

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

Revised: 8/2022

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

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

Version: 1

Effective Time: 20220815