Label: SUMMER CAMP ENVIRO UV BROAD SPECTRUM SPF 50- octisalate, avobenzone, homosalate spray
- NDC Code(s): 58443-0554-3
- Packager: Prime Enterprises Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated August 16, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
-
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
- INACTIVE INGREDIENTS
- Questions or Comments?
- Summer Camp Enviro UV Facial Sunscreen Mist Broad spectrum SPF 50
-
INGREDIENTS AND APPEARANCE
SUMMER CAMP ENVIRO UV BROAD SPECTRUM SPF 50
octisalate, avobenzone, homosalate sprayProduct 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)
