- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
-
Use
- Helps prevent sunburn.
- If used as directed with other sun protection measures (see Directions), helps decrease the risk of skin cancer and early skin aging caused by the sun.
- Warnings
-
Directions
- Apply liberally 30 minutes before sun exposure.
- Reapply at least every two 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 help 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
-
Inactive ingredients
Cyclopentasiloxane, Isododecane, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Caprylyl Methicone, Lauryl PEG-10 Tris (Trimethylsiloxy) Silylethyl Dimethicone, Dimethicone/Bis-Isobutyl PPG-20 Cross polymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Water/Aqua/Eau, Polyhydroxystearic Acid, Avena Sativa (Oat) Kernel Oil, Bisabolol, Saccharomyces Lysate Extract, Zingiber Officinale (Ginger) Root Extract, Boerhavia Diffusa Root Extract, Melia Azadirachta Seed Extract, Melia Azadirachta Leaf Extract, Avena Sativa (Oat) Kernel Extract, Amber Powder, Coccinia Indica Fruit Extract, Solanum Melongena (Eggplant) Fruit Extract, Ocimum Basilicum (Basil) Leaf Extract, Curcuma Longa (Tumeric) Leaf Extract, Pearl Powder, Dodecene, Hydroxyphenyl Propamidobenzoic Acid, Silica Dimethyl Silylate, Dimethicone, Butylene Glycol, Pentylene Glycol, Glycerin, Alumina, PEG-10, Stearic Acid, Triethoxycaprylylsilane, Ethylhexylglycerin, Ascorbyl Palmitate, Potassium Sorbate, Phenoxyethanol, Iron Oxides CI 77492, CI 77499.
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 22 mL Tube Carton
-
INGREDIENTS AND APPEARANCE
REDNESS RELIEF PRIMER SPF20
titanium dioxide and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68479-009 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 30 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 85 mg in 1 mL Inactive Ingredients Ingredient Name Strength Cyclomethicone 5 (UNII: 0THT5PCI0R) Isododecane (UNII: A8289P68Y2) Medium-Chain Triglycerides (UNII: C9H2L21V7U) Caprylyl Trisiloxane (UNII: Q95M2P1KJL) Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer (UNII: O4I3UFO6ZF) Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5) Water (UNII: 059QF0KO0R) Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F) Oat Kernel Oil (UNII: 3UVP41R77R) Levomenol (UNII: 24WE03BX2T) Saccharomyces Lysate (UNII: R85W246Z1C) Ginger (UNII: C5529G5JPQ) Boerhavia Diffusa Root (UNII: KR0SR09KYL) Azadirachta Indica Seed (UNII: P1NV46V59R) Azadirachta Indica Leaf (UNII: HKY915780T) Oat (UNII: Z6J799EAJK) Amber (UNII: 70J9Z0J26P) Coccinia Grandis Fruit (UNII: VLJ6WOT3K5) Eggplant (UNII: W5K7RAS4VK) Basil (UNII: 2U0KZP0FDW) Curcuma Longa Leaf (UNII: H2HC4RY52C) Pearl (Hyriopsis Cumingii) (UNII: A75L5FZ40U) Dodecene (UNII: WYE669F3GR) Hydroxyphenyl Propamidobenzoic Acid (UNII: 25KRT26H77) Silica Dimethyl Silylate (UNII: EU2PSP0G0W) Dimethicone (UNII: 92RU3N3Y1O) Butylene Glycol (UNII: 3XUS85K0RA) Pentylene Glycol (UNII: 50C1307PZG) Glycerin (UNII: PDC6A3C0OX) Aluminum Oxide (UNII: LMI26O6933) POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y) Stearic Acid (UNII: 4ELV7Z65AP) Triethoxycaprylylsilane (UNII: LDC331P08E) Ethylhexylglycerin (UNII: 147D247K3P) Ascorbyl Palmitate (UNII: QN83US2B0N) Potassium Sorbate (UNII: 1VPU26JZZ4) Phenoxyethanol (UNII: HIE492ZZ3T) Ferric Oxide Yellow (UNII: EX438O2MRT) Ferrosoferric Oxide (UNII: XM0M87F357) Product Characteristics Color GREEN Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68479-009-02 1 in 1 CARTON 1 22 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:68479-009-00 2 mL in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 03/21/2014 Labeler - Dermalogica, Inc. (177698560) Establishment Name Address ID/FEI Business Operations PakLab 790530976 MANUFACTURE(68479-009) Establishment Name Address ID/FEI Business Operations Diamond Wipes 161104729 MANUFACTURE(68479-009)