![LUMENE VALO DAY MOISTURIZER SPF 15 SUNSCREEN BROAD SPECTRUM SPF 15 (OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE) CREAM [LUMENE OY]](https://medic.hrt.org//dailymed/images/d1b90cd4-5059-41ca-b24e-15dcb073c9e3/General Label.jpg)
![LUMENE VALO DAY MOISTURIZER SPF 15 SUNSCREEN BROAD SPECTRUM SPF 15 (OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE) CREAM [LUMENE OY]](https://medic.hrt.org//dailymed/images/d1b90cd4-5059-41ca-b24e-15dcb073c9e3/Inactive Ingredients.jpg)
![LUMENE VALO DAY MOISTURIZER SPF 15 SUNSCREEN BROAD SPECTRUM SPF 15 (OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE) CREAM [LUMENE OY]](https://medic.hrt.org//dailymed/images/d1b90cd4-5059-41ca-b24e-15dcb073c9e3/Package Label Details.jpg)
| NDC | 67692-242-00, 67692-242-01, 67692-242-02 |
| Set ID | d1b90cd4-5059-41ca-b24e-15dcb073c9e3 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Lumene Oy |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- Drug Facts
- ACTIVE INGREDIENTS
- USES
- WARNINGS
-
DIRECTIONS
- Apply liberally 15 minutes before sun exposure
- Use a water resistant sunscreen if swimming or sweating
- Reapply at least every 2 hours
- Children under 6 months of age: ask a doctor
- 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 value of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially form 10 a.m. -2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses
- OTHER INFORMATION
-
INACTIVE INGREDIENTS:
AQUA (WATER), HEPTYL UNDECYLENATE, CETEARYL ALCOHOL, HYDROGENATED POLYISOBUTENE, PROPANEDIOL, GLYCERIN, SQUALANE, PHENOXYETHANOL, BUTYLENE GLYCOL, CETEARYL GLUCOSIDE, TOCOPHERYL ACETATE, GLYCERYL STEARATE, PEG-100 STEARATE, PANTHENOL, POLYACRYLAMIDE, XANTHAN GUM, ACRYLATES/C1O-30 ALKYL ACRYLATE CROSSPOLYMER, LECITHIN, C13-14 ISOPARAFFIN, (CI 77891) TITANIUM DIOXIDE, DISODIUM EDTA, ETHYLHEXYLGLYCERIN, MAGNESIUM ASCORBYL PHOSPHATE, MICA, HIPPOPHAE RHAMNOIDES (SEA BUCKTHORN) OIL, RUBUS CHAMAEMORUS (CLOUDBERRY) SEED OIL, PEG-8, CAPRYLYL GLYCOL, SODIUM HYDROXIDE, LAURETH-7, TOCOPHEROL, LACTIC ACID, SERINE, SODIUM LACTATE, SORBITOL TEA-LACTATE, UREA, RUBUS CHAMAEMORUS (CLOUDBERRY) SEED EXTRACT, ASCORBYL PALMITATE, SODIUM CHLORIDE, CHONDRUS CRISPUS (CARRAGEENAN), ASCORBIC ACID, CITRIC ACID, ALLANTOIN, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, LIMONENE, LINALOOL, BUTYLPHENYL METHYLPROPIONAL, GERANIOL, CITRAL, HEXYL CINNAMAL, CITRONELLOL, PARFUM(FRAGRANCE)
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
LUMENE VALO DAY MOISTURIZER SPF 15 SUNSCREEN BROAD SPECTRUM SPF 15
octinoxate, oxybenzone, octisalate, avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67692-242 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 50 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 40 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) WATER (UNII: 059QF0KO0R) HEPTYL UNDECYLENATE (UNII: W77QUB6GXO) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) PROPANEDIOL (UNII: 5965N8W85T) GLYCERIN (UNII: PDC6A3C0OX) SQUALANE (UNII: GW89575KF9) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) PANTHENOL (UNII: WV9CM0O67Z) XANTHAN GUM (UNII: TTV12P4NEE) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) MICA (UNII: V8A1AW0880) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SODIUM HYDROXIDE (UNII: 55X04QC32I) LAURETH-7 (UNII: Z95S6G8201) TOCOPHEROL (UNII: R0ZB2556P8) LACTIC ACID (UNII: 33X04XA5AT) SERINE (UNII: 452VLY9402) SODIUM LACTATE (UNII: TU7HW0W0QT) ASCORBYL PALMITATE (UNII: QN83US2B0N) SODIUM CHLORIDE (UNII: 451W47IQ8X) CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78) ASCORBIC ACID (UNII: PQ6CK8PD0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ALLANTOIN (UNII: 344S277G0Z) SUNFLOWER OIL (UNII: 3W1JG795YI) ROSEMARY (UNII: IJ67X351P9) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) GERANIOL (UNII: L837108USY) CITRAL (UNII: T7EU0O9VPP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67692-242-00 1 in 1 BOX 09/10/2016 1 50 mL in 1 JAR; Type 0: Not a Combination Product 2 NDC:67692-242-02 1 in 1 BOX 11/22/2017 04/19/2020 2 50 mL in 1 JAR; Type 0: Not a Combination Product 3 NDC:67692-242-01 15 mL in 1 JAR; Type 0: Not a Combination Product 09/10/2016 09/21/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/10/2016 Labeler - Lumene Oy (401630129)
