Label: EVE LOM DAILY PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN- homosalate, octisalate, oxybenzone, avobenzone, octinoxate and octocrylene cream
- NDC Code(s): 61601-1217-8
- Packager: Space Brands Limited
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 December 16, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- Uses
- Warnings
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
Directions
- apply liberally 15 minutes before sun exposure
- children under 6 months of age: Ask a doctor
- reapply at least every 2 hours
- use a water-resistant sunscreen if swimming or sweating
- 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 iof 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
-
Inactive ingredients
water, niacinamide, phenyl trimethicone, cetearyl alcohol, caprylic/capric triglyceride, behentrimonium methosulfate, divinyldimethicone/dimethicone copolymer, polysilicone-15, phenoxyethanol, cetearyl olivate, sorbitan olivate, polyquaternium-37, propylene glycol dicaprylate/dicaprate, spilanthes acmella flower extract, tocopheryl acetate, ascorbyl tetraisopalmitate, ethylhexylglycerin, lactic acid, PPG-1 trideceth-6, C12-13 pareth-3, C12-13 pareth-23, sodium citrate, citric acid, BHT.
- Other information
- PRINCIPAL DISPLAY/OUTSIDE PANEL - 5 mL Wallet Sachet
- INSIDE PANEL - 5 mL Sachet
-
INGREDIENTS AND APPEARANCE
EVE LOM DAILY PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN
homosalate, octisalate, oxybenzone, avobenzone, octinoxate and octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61601-1217 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 0.5 g in 5 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.25 g in 5 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.25 g in 5 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.15 g in 5 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.15 g in 5 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 0.135 g in 5 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) NIACINAMIDE (UNII: 25X51I8RD4) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61) POLYSILICONE-15 (UNII: F8DRP5BB29) PHENOXYETHANOL (UNII: HIE492ZZ3T) CETEARYL OLIVATE (UNII: 58B69Q84JO) SORBITAN OLIVATE (UNII: MDL271E3GR) POLYQUATERNIUM 37 (200 MPA.S) (UNII: 67C1D6YV24) PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ACMELLA OLERACEA FLOWER (UNII: 2794N5KM0K) ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) LACTIC ACID (UNII: 33X04XA5AT) PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q) C12-13 PARETH-3 (UNII: DMC6N3419L) C12-13 PARETH-23 (UNII: J1WW1510L4) SODIUM CITRATE (UNII: 1Q73Q2JULR) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61601-1217-8 1 in 1 PACKAGE 06/02/2014 1 5 mL in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/02/2014 Labeler - Space Brands Limited (218214381)